JMI Laboratories

North Liberty, Iowa, United States

JMI Laboratories

North Liberty, Iowa, United States
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BEDMINSTER, NJ / ACCESSWIRE / July 12, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided a comprehensive overview and update on its ongoing pre-clinical and clinical development programs, based on its taurolidine technology platform. The "R&D Day" event will be webcast live and archived on CorMedix's website. To access the webcast, visit the Events page at www.cormedix.com/media-publications/events/. Keynote speakers include Prabir Roy-Chaudhury, MD, Ph.D., Co-Principal Investigator of the Neutrolin® Phase 3 LOCK-IT 100 clinical trial, Director of the Division of Nephrology and the Arizona Kidney and Vascular Center at University of Arizona, and Co-chair of the American Society for Nephrology's Kidney Health Initiative; Allison O'Neill, M.D., Assistant Professor of Pediatrics at Harvard Medical School and Research Fellow at the Dana-Farber Cancer Institute; Z. Paul Lorenc, M.D., F.A.C.S., World-renowned, board-certified Aesthetic Plastic Surgeon; and Gregory Schultz, Ph.D., Director of the Institute for Wound Research and Professor of Obstetrics and Gynecology at the University of Florida. CorMedix has advanced several preclinical R&D programs, building upon the key characteristics of taurolidine. These include potent anti-microbial activity without resistance, anti-inflammatory properties mediated by a reduction in certain cytokines including IL-1, IL-6 and TNF, as well as selective pro-apoptotic and cytotoxic activity against cancer cells. Taurolidine is also known to penetrate biofilms and retain its activity against highly drug-resistant bacteria and fungi, making it a potentially valuable molecule for addressing the unmet need for new anti-microbial products. The R&D Day event focuses on three key areas of CorMedix's taurolidine-based pipeline: CorMedix has focused its R&D efforts to three initial medical device areas where taurolidine incorporation may add value and potentially improve patient outcomes. These include: The 2018 U.S. market is projected to be $1.7 billion for sutures, and $1.0 billion each for hydrogels and non-woven meshes. CorMedix has been successful in integrating multiple concentrations of taurolidine (2%-10%) into monofilament suture materials, where the taurolidine is dispersed throughout the matrix of the fibers (one prepared with a homopolymer of epsilon-caprolactone and another fiber composed of rho-dioxanone). Taurolidine could also be loaded onto the surface of multifilament suture materials by integrating the drug into the coating layer. The taurolidine-incorporated sutures were tested against clinically significant bacterial species, including methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis, and Pseudomonas aeruginosa using two different in vitro assays. Effectiveness of the materials at eradicating these potentially deadly microbes was confirmed using zone of inhibition (ZOI), where bacterial growth was completely inhibited in the vicinity of the taurolidine-loaded fibers; and by direct bacteria killing assays that showed ~10 log (>99.9%) reduction in bacteria following incubation with 6% taurolidine sutures. CorMedix is in the process of testing large-scale manufacturing of polydioxanone sutures containing 7% taurolidine that mimics the processes in use today. It involves creating drug-loaded polymer pellets that can be extruded in a line that enables annealing and drawing similar to the current commercial manufacturing of sutures. Zone of inhibition studies recently confirmed that the taurolidine sutures retain their antimicrobial activity when manufactured by this scalable process. Several non-woven mesh candidates were prepared by electrospinning using a variety of commercially available resorbable polymer constructs and loaded with taurolidine at strengths ranging from 21-59% by weight. The meshes were submerged in suspended cultures of P. aeruginosa and MRSA. Taurolidine-incorporated meshes demonstrated complete killing of these deadly bacteria at all strengths tested in less than four hours of exposure. Hyaluronic acid (HA) hydrogels containing taurolidine demonstrated complete killing of suspended cultures of P. aeruginosa and MRSA at all concentrations of Taurolidine tested (1.5%-6%). Furthermore, taurolidine hydrogels were effective at penetrating mature biofilms of P. aeruginosa on the surface of pig skin explants. High molecular weight HA + 3% taurolidine and myristic acid (penetration enhancer) also showed complete killing of the biofilm bacteria. CorMedix is currently conducting proof-of-concept studies in animal models for each of its medical device candidates, and these studies will continue during the second half of 2017. CorMedix's regulatory strategy for its taurolidine-incorporated medical devices is to utilize the 510(k) pathway, which uses predicate medical devices which were approved previously for similar indications, to potentially accelerate the timing and reduce the amount of data and testing required for clearance by the U.S. Food and Drug Administration (FDA). To utilize this pathway CorMedix must identify predicate device(s) and demonstrate that its candidate is substantially equivalent to the predicate device. CorMedix has identified such potential predicate devices for each of its candidates and plans to pursue this pathway as efficiently as possible. In parallel, CorMedix intends to seek CE Marking for its taurolidine-based medical devices for commercialization in European Countries and other territories. CorMedix is collaborating with the Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC) on preclinical development of taurolidine-based therapies for cancer. To date, initial candidate therapies have been developed and formulated for delivery to tumors, including potential combination therapies involving taurolidine plus another chemotherapy. The anti-cancer activity of these candidates was evaluated successfully in various cancer cell lines and animal studies are being planned. The goal of these early studies is to establish feasibility and proof-of-concept, as well as determine the optimal cancer indication(s) to pursue and with which therapeutic regimen. Currently, CorMedix and POETIC expect to utilize nano-technologies to deliver taurolidine, either alone or in a drug combination, to enable a slow, sustained release of the drug within tumors. Multiple nanoparticle platforms are being evaluated. Nanoparticle delivery of taurolidine monotherapy markedly enhanced its ability to kill neuroblastoma cells in vitro compared to free taurolidine (IC50 = 37.6 uM vs 99.7 uM, respectively). They were also effective at killing other tumor types, including non-small cell lung cancer (IC50 = 137.8 uM). Furthermore, co-administration of taurolidine nanoparticles and nanoparticles containing the chemotherapy agent vincristine demonstrated a synergistic effect against neuroblastoma cell lines compared to the activity of either drug alone. This potential synergy is supported by published scientific research showing that taurolidine can enhance the activity of cytotoxic drugs, including vincristine, against neuroblastoma cells in vitro. Pediatric neuroblastoma is a rare cancer and an Orphan Disease opportunity. CorMedix and its collaborators are focused on advancing this program through preclinical studies and determining a potential clinical strategy once in vivo proof-of-concept is achieved. Neutrolin® is a taurolidine-based, non-antibiotic, antimicrobial solution designed to prevent costly and dangerous CRBSIs and thrombosis by acting in the catheter lumen between catheter usage. CorMedix is developing Neutrolin® in a pivotal Phase 3 clinical program in the United States for preventing CRBSIs in patients with end stage renal disease (ESRD) undergoing hemodialysis via a central venous catheter. The product has CE Marking and is available in Europe and other territories through marketing and distribution partners. Taurolidine, the active antimicrobial in Neutrolin®, is effective against a broad range of bacteria and fungi, including antibiotic-resistant strains, with no reported resistance in a clinical setting. An important contributor to antibiotic resistance is the ability of certain microorganisms to form biofilms. Biofilms play an important role in the tenacity and pathology of a number of infectious diseases, because within the biofilm, microorganisms tend to be less metabolically active and highly resistant to antibiotics. Taurolidine is not an antibiotic and its ability to penetrate mature biofilms of clinically relevant bacteria has been demonstrated successfully. Biofilms are also present on a very high percentage of medical devices, including central venous catheters. The taurolidine in Neutrolin® may prevent biofilm from forming on the catheter lumen in between uses, making it an effective means of maintaining proper bloodflow and catheter patency. Infections are now on par with cardiovascular complications as a primary reason for hospitalization and mortality among ESRD patients receiving hemodialysis, and major health organizations are focused on reducing or eliminating CRBSI. The American Society for Nephrology recently partnered with the U.S. Centers for Disease Control and Prevention (CDC) to develop the Nephrologists Transforming Dialysis Safety (NTDS) project to promote infection prevention in outpatient dialysis facilities. The use of innovative products like Neutrolin®, which aligns with current clinical and outpatient workflows as a catheter lock solution, could become an important part of this effort to minimize CRBSI and improve outcomes for patients. Multidrug-resistant Candida auris is an emerging pathogenic yeast species causing serious illness in humans, which the CDC has cited as a "serious global health threat." C. auris is associated with life-threatening bloodstream and wound infections, causing recent hospital outbreaks globally with high mortality. It is resistant to all standard antifungals and is able to form biofilms that enhance its pathogenicity and persistence in the hospital setting. Patients with central venous catheters are among those at highest risk of C. auris infection, which can lead to potentially deadly CRBSIs. CorMedix announced the results of a special culture sensitivity test of taurolidine against clinical isolates of C. auris, which showed 100% inhibition of the yeast at the concentration of taurolidine currently contained in Neutrolin®. As such, Neutrolin may prevent C. auris infections in one of the highest risk patient populations. Furthermore, incorporation of taurolidine into sutures, meshes, and hydrogels may help prevent C. auris infections in surgical wounds, burns and diabetic foot ulcers. The sensitivity testing was performed by premier microbiology and antimicrobial surveillance laboratory JMI Laboratories. CorMedix looks forward to working with global regulatory agencies to leverage the benefits of taurolidine to possibly help prevent resistant microbial infections. Khoso Baluch, President and CEO of CorMedix, stated, "We are pleased to provide this overview of our R&D pipeline, which represents multiple opportunities to generate significant long-term value for our shareholders. Our focused efforts in the medical device space and in oncology have demonstrated early successes that we find very encouraging as we advance these programs in proof-of-concept studies, which are currently in progress in animals. Leveraging the unique properties of taurolidine in these areas is a significant part of our overall growth strategy, as we continue to execute on the U.S. clinical development and European commercialization of Neutrolin®. We thank our shareholders and our strategic collaborators for their continued support." The event will be webcast live and archived on CorMedix's website. To access the webcast, visit the Events page at www.cormedix.com/media-publications/events/. The R&D Day will include several Q&A sessions. To submit a question during the event, please email [email protected]. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to possible uses of taurolidine, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on planned or future research, including for additional uses for taurolidine; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.


BEDMINSTER, NJ / ACCESSWIRE / July 12, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided a comprehensive overview and update on its ongoing pre-clinical and clinical development programs, based on its taurolidine technology platform. The "R&D Day" event will be webcast live and archived on CorMedix's website. To access the webcast, visit the Events page at www.cormedix.com/media-publications/events/. Keynote speakers include Prabir Roy-Chaudhury, MD, Ph.D., Co-Principal Investigator of the Neutrolin® Phase 3 LOCK-IT 100 clinical trial, Director of the Division of Nephrology and the Arizona Kidney and Vascular Center at University of Arizona, and Co-chair of the American Society for Nephrology's Kidney Health Initiative; Allison O'Neill, M.D., Assistant Professor of Pediatrics at Harvard Medical School and Research Fellow at the Dana-Farber Cancer Institute; Z. Paul Lorenc, M.D., F.A.C.S., World-renowned, board-certified Aesthetic Plastic Surgeon; and Gregory Schultz, Ph.D., Director of the Institute for Wound Research and Professor of Obstetrics and Gynecology at the University of Florida. CorMedix has advanced several preclinical R&D programs, building upon the key characteristics of taurolidine. These include potent anti-microbial activity without resistance, anti-inflammatory properties mediated by a reduction in certain cytokines including IL-1, IL-6 and TNF, as well as selective pro-apoptotic and cytotoxic activity against cancer cells. Taurolidine is also known to penetrate biofilms and retain its activity against highly drug-resistant bacteria and fungi, making it a potentially valuable molecule for addressing the unmet need for new anti-microbial products. The R&D Day event focuses on three key areas of CorMedix's taurolidine-based pipeline: Development of medical devices that incorporate taurolidine Development of taurolidine-based therapy for cancer Continued development of Neutrolin® for the prevention of bloodstream infections CorMedix has focused its R&D efforts to three initial medical device areas where taurolidine incorporation may add value and potentially improve patient outcomes. These include: Development of anti-microbial suture materials to prevent surgical site infections (SSIs) Development of antimicrobial hydrogels to help prevent infections in burns and other wounds as well as treat infections in those sites. The hydrogels may also be effective as treatments for diabetic foot ulcers. Development of non-woven antimicrobial meshes to prevent infection and graft failure following hernia repair and reconstructive surgery The 2018 U.S. market is projected to be $1.7 billion for sutures, and $1.0 billion each for hydrogels and non-woven meshes. Development of Anti-Microbial Suture materials CorMedix has been successful in integrating multiple concentrations of taurolidine (2%-10%) into monofilament suture materials, where the taurolidine is dispersed throughout the matrix of the fibers (one prepared with a homopolymer of epsilon-caprolactone and another fiber composed of rho-dioxanone). Taurolidine could also be loaded onto the surface of multifilament suture materials by integrating the drug into the coating layer. The taurolidine-incorporated sutures were tested against clinically significant bacterial species, including methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis, and Pseudomonas aeruginosa using two different in vitro assays. Effectiveness of the materials at eradicating these potentially deadly microbes was confirmed using zone of inhibition (ZOI), where bacterial growth was completely inhibited in the vicinity of the taurolidine-loaded fibers; and by direct bacteria killing assays that showed ~10 log (>99.9%) reduction in bacteria following incubation with 6% taurolidine sutures. CorMedix is in the process of testing large-scale manufacturing of polydioxanone sutures containing 7% taurolidine that mimics the processes in use today. It involves creating drug-loaded polymer pellets that can be extruded in a line that enables annealing and drawing similar to the current commercial manufacturing of sutures. Zone of inhibition studies recently confirmed that the taurolidine sutures retain their antimicrobial activity when manufactured by this scalable process. Development of Anti-Microbial Non-Woven Meshes Several non-woven mesh candidates were prepared by electrospinning using a variety of commercially available resorbable polymer constructs and loaded with taurolidine at strengths ranging from 21-59% by weight. The meshes were submerged in suspended cultures of P. aeruginosa and MRSA. Taurolidine-incorporated meshes demonstrated complete killing of these deadly bacteria at all strengths tested in less than four hours of exposure. Development of Anti-Microbial Hydrogels Hyaluronic acid (HA) hydrogels containing taurolidine demonstrated complete killing of suspended cultures of P. aeruginosa and MRSA at all concentrations of Taurolidine tested (1.5%-6%). Furthermore, taurolidine hydrogels were effective at penetrating mature biofilms of P. aeruginosa on the surface of pig skin explants. High molecular weight HA + 3% taurolidine and myristic acid (penetration enhancer) also showed complete killing of the biofilm bacteria. CorMedix is currently conducting proof-of-concept studies in animal models for each of its medical device candidates, and these studies will continue during the second half of 2017. CorMedix's regulatory strategy for its taurolidine-incorporated medical devices is to utilize the 510(k) pathway, which uses predicate medical devices which were approved previously for similar indications, to potentially accelerate the timing and reduce the amount of data and testing required for clearance by the U.S. Food and Drug Administration (FDA). To utilize this pathway CorMedix must identify predicate device(s) and demonstrate that its candidate is substantially equivalent to the predicate device. CorMedix has identified such potential predicate devices for each of its candidates and plans to pursue this pathway as efficiently as possible. In parallel, CorMedix intends to seek CE Marking for its taurolidine-based medical devices for commercialization in European Countries and other territories. CorMedix is collaborating with the Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC) on preclinical development of taurolidine-based therapies for cancer. To date, initial candidate therapies have been developed and formulated for delivery to tumors, including potential combination therapies involving taurolidine plus another chemotherapy. The anti-cancer activity of these candidates was evaluated successfully in various cancer cell lines and animal studies are being planned. The goal of these early studies is to establish feasibility and proof-of-concept, as well as determine the optimal cancer indication(s) to pursue and with which therapeutic regimen. Currently, CorMedix and POETIC expect to utilize nano-technologies to deliver taurolidine, either alone or in a drug combination, to enable a slow, sustained release of the drug within tumors. Multiple nanoparticle platforms are being evaluated. Nanoparticle delivery of taurolidine monotherapy markedly enhanced its ability to kill neuroblastoma cells in vitro compared to free taurolidine (IC50 = 37.6 uM vs 99.7 uM, respectively). They were also effective at killing other tumor types, including non-small cell lung cancer (IC50 = 137.8 uM). Furthermore, co-administration of taurolidine nanoparticles and nanoparticles containing the chemotherapy agent vincristine demonstrated a synergistic effect against neuroblastoma cell lines compared to the activity of either drug alone. This potential synergy is supported by published scientific research showing that taurolidine can enhance the activity of cytotoxic drugs, including vincristine, against neuroblastoma cells in vitro. Pediatric neuroblastoma is a rare cancer and an Orphan Disease opportunity. CorMedix and its collaborators are focused on advancing this program through preclinical studies and determining a potential clinical strategy once in vivo proof-of-concept is achieved. Neutrolin® is a taurolidine-based, non-antibiotic, antimicrobial solution designed to prevent costly and dangerous CRBSIs and thrombosis by acting in the catheter lumen between catheter usage. CorMedix is developing Neutrolin® in a pivotal Phase 3 clinical program in the United States for preventing CRBSIs in patients with end stage renal disease (ESRD) undergoing hemodialysis via a central venous catheter. The product has CE Marking and is available in Europe and other territories through marketing and distribution partners. Taurolidine, the active antimicrobial in Neutrolin®, is effective against a broad range of bacteria and fungi, including antibiotic-resistant strains, with no reported resistance in a clinical setting. An important contributor to antibiotic resistance is the ability of certain microorganisms to form biofilms. Biofilms play an important role in the tenacity and pathology of a number of infectious diseases, because within the biofilm, microorganisms tend to be less metabolically active and highly resistant to antibiotics. Taurolidine is not an antibiotic and its ability to penetrate mature biofilms of clinically relevant bacteria has been demonstrated successfully. Biofilms are also present on a very high percentage of medical devices, including central venous catheters. The taurolidine in Neutrolin® may prevent biofilm from forming on the catheter lumen in between uses, making it an effective means of maintaining proper bloodflow and catheter patency. Infections are now on par with cardiovascular complications as a primary reason for hospitalization and mortality among ESRD patients receiving hemodialysis, and major health organizations are focused on reducing or eliminating CRBSI. The American Society for Nephrology recently partnered with the U.S. Centers for Disease Control and Prevention (CDC) to develop the Nephrologists Transforming Dialysis Safety (NTDS) project to promote infection prevention in outpatient dialysis facilities. The use of innovative products like Neutrolin®, which aligns with current clinical and outpatient workflows as a catheter lock solution, could become an important part of this effort to minimize CRBSI and improve outcomes for patients. Multidrug-resistant Candida auris is an emerging pathogenic yeast species causing serious illness in humans, which the CDC has cited as a "serious global health threat." C. auris is associated with life-threatening bloodstream and wound infections, causing recent hospital outbreaks globally with high mortality. It is resistant to all standard antifungals and is able to form biofilms that enhance its pathogenicity and persistence in the hospital setting. Patients with central venous catheters are among those at highest risk of C. auris infection, which can lead to potentially deadly CRBSIs. CorMedix announced the results of a special culture sensitivity test of taurolidine against clinical isolates of C. auris, which showed 100% inhibition of the yeast at the concentration of taurolidine currently contained in Neutrolin®. As such, Neutrolin may prevent C. auris infections in one of the highest risk patient populations. Furthermore, incorporation of taurolidine into sutures, meshes, and hydrogels may help prevent C. auris infections in surgical wounds, burns and diabetic foot ulcers. The sensitivity testing was performed by premier microbiology and antimicrobial surveillance laboratory JMI Laboratories. CorMedix looks forward to working with global regulatory agencies to leverage the benefits of taurolidine to possibly help prevent resistant microbial infections. Khoso Baluch, President and CEO of CorMedix, stated, "We are pleased to provide this overview of our R&D pipeline, which represents multiple opportunities to generate significant long-term value for our shareholders. Our focused efforts in the medical device space and in oncology have demonstrated early successes that we find very encouraging as we advance these programs in proof-of-concept studies, which are currently in progress in animals. Leveraging the unique properties of taurolidine in these areas is a significant part of our overall growth strategy, as we continue to execute on the U.S. clinical development and European commercialization of Neutrolin®. We thank our shareholders and our strategic collaborators for their continued support." The event will be webcast live and archived on CorMedix's website. To access the webcast, visit the Events page at www.cormedix.com/media-publications/events/. The R&D Day will include several Q&A sessions. To submit a question during the event, please email Cormedix@tiberend.com. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to possible uses of taurolidine, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on planned or future research, including for additional uses for taurolidine; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. BEDMINSTER, NJ / ACCESSWIRE / July 12, 2017 / CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided a comprehensive overview and update on its ongoing pre-clinical and clinical development programs, based on its taurolidine technology platform. The "R&D Day" event will be webcast live and archived on CorMedix's website. To access the webcast, visit the Events page at www.cormedix.com/media-publications/events/. Keynote speakers include Prabir Roy-Chaudhury, MD, Ph.D., Co-Principal Investigator of the Neutrolin® Phase 3 LOCK-IT 100 clinical trial, Director of the Division of Nephrology and the Arizona Kidney and Vascular Center at University of Arizona, and Co-chair of the American Society for Nephrology's Kidney Health Initiative; Allison O'Neill, M.D., Assistant Professor of Pediatrics at Harvard Medical School and Research Fellow at the Dana-Farber Cancer Institute; Z. Paul Lorenc, M.D., F.A.C.S., World-renowned, board-certified Aesthetic Plastic Surgeon; and Gregory Schultz, Ph.D., Director of the Institute for Wound Research and Professor of Obstetrics and Gynecology at the University of Florida. CorMedix has advanced several preclinical R&D programs, building upon the key characteristics of taurolidine. These include potent anti-microbial activity without resistance, anti-inflammatory properties mediated by a reduction in certain cytokines including IL-1, IL-6 and TNF, as well as selective pro-apoptotic and cytotoxic activity against cancer cells. Taurolidine is also known to penetrate biofilms and retain its activity against highly drug-resistant bacteria and fungi, making it a potentially valuable molecule for addressing the unmet need for new anti-microbial products. The R&D Day event focuses on three key areas of CorMedix's taurolidine-based pipeline: Development of medical devices that incorporate taurolidine Development of taurolidine-based therapy for cancer Continued development of Neutrolin® for the prevention of bloodstream infections CorMedix has focused its R&D efforts to three initial medical device areas where taurolidine incorporation may add value and potentially improve patient outcomes. These include: Development of anti-microbial suture materials to prevent surgical site infections (SSIs) Development of antimicrobial hydrogels to help prevent infections in burns and other wounds as well as treat infections in those sites. The hydrogels may also be effective as treatments for diabetic foot ulcers. Development of non-woven antimicrobial meshes to prevent infection and graft failure following hernia repair and reconstructive surgery The 2018 U.S. market is projected to be $1.7 billion for sutures, and $1.0 billion each for hydrogels and non-woven meshes. Development of Anti-Microbial Suture materials CorMedix has been successful in integrating multiple concentrations of taurolidine (2%-10%) into monofilament suture materials, where the taurolidine is dispersed throughout the matrix of the fibers (one prepared with a homopolymer of epsilon-caprolactone and another fiber composed of rho-dioxanone). Taurolidine could also be loaded onto the surface of multifilament suture materials by integrating the drug into the coating layer. The taurolidine-incorporated sutures were tested against clinically significant bacterial species, including methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus epidermidis, and Pseudomonas aeruginosa using two different in vitro assays. Effectiveness of the materials at eradicating these potentially deadly microbes was confirmed using zone of inhibition (ZOI), where bacterial growth was completely inhibited in the vicinity of the taurolidine-loaded fibers; and by direct bacteria killing assays that showed ~10 log (>99.9%) reduction in bacteria following incubation with 6% taurolidine sutures. CorMedix is in the process of testing large-scale manufacturing of polydioxanone sutures containing 7% taurolidine that mimics the processes in use today. It involves creating drug-loaded polymer pellets that can be extruded in a line that enables annealing and drawing similar to the current commercial manufacturing of sutures. Zone of inhibition studies recently confirmed that the taurolidine sutures retain their antimicrobial activity when manufactured by this scalable process. Development of Anti-Microbial Non-Woven Meshes Several non-woven mesh candidates were prepared by electrospinning using a variety of commercially available resorbable polymer constructs and loaded with taurolidine at strengths ranging from 21-59% by weight. The meshes were submerged in suspended cultures of P. aeruginosa and MRSA. Taurolidine-incorporated meshes demonstrated complete killing of these deadly bacteria at all strengths tested in less than four hours of exposure. Development of Anti-Microbial Hydrogels Hyaluronic acid (HA) hydrogels containing taurolidine demonstrated complete killing of suspended cultures of P. aeruginosa and MRSA at all concentrations of Taurolidine tested (1.5%-6%). Furthermore, taurolidine hydrogels were effective at penetrating mature biofilms of P. aeruginosa on the surface of pig skin explants. High molecular weight HA + 3% taurolidine and myristic acid (penetration enhancer) also showed complete killing of the biofilm bacteria. CorMedix is currently conducting proof-of-concept studies in animal models for each of its medical device candidates, and these studies will continue during the second half of 2017. CorMedix's regulatory strategy for its taurolidine-incorporated medical devices is to utilize the 510(k) pathway, which uses predicate medical devices which were approved previously for similar indications, to potentially accelerate the timing and reduce the amount of data and testing required for clearance by the U.S. Food and Drug Administration (FDA). To utilize this pathway CorMedix must identify predicate device(s) and demonstrate that its candidate is substantially equivalent to the predicate device. CorMedix has identified such potential predicate devices for each of its candidates and plans to pursue this pathway as efficiently as possible. In parallel, CorMedix intends to seek CE Marking for its taurolidine-based medical devices for commercialization in European Countries and other territories. CorMedix is collaborating with the Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC) on preclinical development of taurolidine-based therapies for cancer. To date, initial candidate therapies have been developed and formulated for delivery to tumors, including potential combination therapies involving taurolidine plus another chemotherapy. The anti-cancer activity of these candidates was evaluated successfully in various cancer cell lines and animal studies are being planned. The goal of these early studies is to establish feasibility and proof-of-concept, as well as determine the optimal cancer indication(s) to pursue and with which therapeutic regimen. Currently, CorMedix and POETIC expect to utilize nano-technologies to deliver taurolidine, either alone or in a drug combination, to enable a slow, sustained release of the drug within tumors. Multiple nanoparticle platforms are being evaluated. Nanoparticle delivery of taurolidine monotherapy markedly enhanced its ability to kill neuroblastoma cells in vitro compared to free taurolidine (IC50 = 37.6 uM vs 99.7 uM, respectively). They were also effective at killing other tumor types, including non-small cell lung cancer (IC50 = 137.8 uM). Furthermore, co-administration of taurolidine nanoparticles and nanoparticles containing the chemotherapy agent vincristine demonstrated a synergistic effect against neuroblastoma cell lines compared to the activity of either drug alone. This potential synergy is supported by published scientific research showing that taurolidine can enhance the activity of cytotoxic drugs, including vincristine, against neuroblastoma cells in vitro. Pediatric neuroblastoma is a rare cancer and an Orphan Disease opportunity. CorMedix and its collaborators are focused on advancing this program through preclinical studies and determining a potential clinical strategy once in vivo proof-of-concept is achieved. Neutrolin® is a taurolidine-based, non-antibiotic, antimicrobial solution designed to prevent costly and dangerous CRBSIs and thrombosis by acting in the catheter lumen between catheter usage. CorMedix is developing Neutrolin® in a pivotal Phase 3 clinical program in the United States for preventing CRBSIs in patients with end stage renal disease (ESRD) undergoing hemodialysis via a central venous catheter. The product has CE Marking and is available in Europe and other territories through marketing and distribution partners. Taurolidine, the active antimicrobial in Neutrolin®, is effective against a broad range of bacteria and fungi, including antibiotic-resistant strains, with no reported resistance in a clinical setting. An important contributor to antibiotic resistance is the ability of certain microorganisms to form biofilms. Biofilms play an important role in the tenacity and pathology of a number of infectious diseases, because within the biofilm, microorganisms tend to be less metabolically active and highly resistant to antibiotics. Taurolidine is not an antibiotic and its ability to penetrate mature biofilms of clinically relevant bacteria has been demonstrated successfully. Biofilms are also present on a very high percentage of medical devices, including central venous catheters. The taurolidine in Neutrolin® may prevent biofilm from forming on the catheter lumen in between uses, making it an effective means of maintaining proper bloodflow and catheter patency. Infections are now on par with cardiovascular complications as a primary reason for hospitalization and mortality among ESRD patients receiving hemodialysis, and major health organizations are focused on reducing or eliminating CRBSI. The American Society for Nephrology recently partnered with the U.S. Centers for Disease Control and Prevention (CDC) to develop the Nephrologists Transforming Dialysis Safety (NTDS) project to promote infection prevention in outpatient dialysis facilities. The use of innovative products like Neutrolin®, which aligns with current clinical and outpatient workflows as a catheter lock solution, could become an important part of this effort to minimize CRBSI and improve outcomes for patients. Multidrug-resistant Candida auris is an emerging pathogenic yeast species causing serious illness in humans, which the CDC has cited as a "serious global health threat." C. auris is associated with life-threatening bloodstream and wound infections, causing recent hospital outbreaks globally with high mortality. It is resistant to all standard antifungals and is able to form biofilms that enhance its pathogenicity and persistence in the hospital setting. Patients with central venous catheters are among those at highest risk of C. auris infection, which can lead to potentially deadly CRBSIs. CorMedix announced the results of a special culture sensitivity test of taurolidine against clinical isolates of C. auris, which showed 100% inhibition of the yeast at the concentration of taurolidine currently contained in Neutrolin®. As such, Neutrolin may prevent C. auris infections in one of the highest risk patient populations. Furthermore, incorporation of taurolidine into sutures, meshes, and hydrogels may help prevent C. auris infections in surgical wounds, burns and diabetic foot ulcers. The sensitivity testing was performed by premier microbiology and antimicrobial surveillance laboratory JMI Laboratories. CorMedix looks forward to working with global regulatory agencies to leverage the benefits of taurolidine to possibly help prevent resistant microbial infections. Khoso Baluch, President and CEO of CorMedix, stated, "We are pleased to provide this overview of our R&D pipeline, which represents multiple opportunities to generate significant long-term value for our shareholders. Our focused efforts in the medical device space and in oncology have demonstrated early successes that we find very encouraging as we advance these programs in proof-of-concept studies, which are currently in progress in animals. Leveraging the unique properties of taurolidine in these areas is a significant part of our overall growth strategy, as we continue to execute on the U.S. clinical development and European commercialization of Neutrolin®. We thank our shareholders and our strategic collaborators for their continued support." The event will be webcast live and archived on CorMedix's website. To access the webcast, visit the Events page at www.cormedix.com/media-publications/events/. The R&D Day will include several Q&A sessions. To submit a question during the event, please email Cormedix@tiberend.com. CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to possible uses of taurolidine, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on planned or future research, including for additional uses for taurolidine; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.


CHAPEL HILL, N.C., June 02, 2017 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that researchers will present data from eight studies of fusidic acid and solithromycin at the American Society for Microbiology (ASM) 2017 meeting in New Orleans, LA. “We are pleased that ASM has recognized data informing important potential uses of solithromycin and fusidic acid with two late breakers and eight overall presentations at the conference,” said David Oldach, M.D., chief medical officer of Cempra. In addition, Toyama, Cempra’s partner for solithromycin in Japan, and JMI Laboratories, an independent laboratory conducting work supported by Cempra, will present the following abstracts: Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for CABP for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd. (Toyama), a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Solithromycin is also in development for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic acid is Cempra's second product candidate, which has completed a phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is also studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com. Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: results of our and our strategic commercial partners' preclinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community acquired bacterial pneumonia; our dependence on the success of solithromycin and fusidic acid; our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our ability to produce and sell any approved products and the price we are able to realize for those products; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.


CHAPEL HILL, N.C., June 02, 2017 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that researchers will present data from eight studies of fusidic acid and solithromycin at the American Society for Microbiology (ASM) 2017 meeting in New Orleans, LA. “We are pleased that ASM has recognized data informing important potential uses of solithromycin and fusidic acid with two late breakers and eight overall presentations at the conference,” said David Oldach, M.D., chief medical officer of Cempra. In addition, Toyama, Cempra’s partner for solithromycin in Japan, and JMI Laboratories, an independent laboratory conducting work supported by Cempra, will present the following abstracts: Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for CABP for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd. (Toyama), a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Solithromycin is also in development for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic acid is Cempra's second product candidate, which has completed a phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is also studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com. Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: results of our and our strategic commercial partners' preclinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community acquired bacterial pneumonia; our dependence on the success of solithromycin and fusidic acid; our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our ability to produce and sell any approved products and the price we are able to realize for those products; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.


CHAPEL HILL, N.C., June 02, 2017 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that researchers will present data from eight studies of fusidic acid and solithromycin at the American Society for Microbiology (ASM) 2017 meeting in New Orleans, LA. “We are pleased that ASM has recognized data informing important potential uses of solithromycin and fusidic acid with two late breakers and eight overall presentations at the conference,” said David Oldach, M.D., chief medical officer of Cempra. In addition, Toyama, Cempra’s partner for solithromycin in Japan, and JMI Laboratories, an independent laboratory conducting work supported by Cempra, will present the following abstracts: Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for CABP for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd. (Toyama), a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Solithromycin is also in development for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic acid is Cempra's second product candidate, which has completed a phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is also studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com. Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: results of our and our strategic commercial partners' preclinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community acquired bacterial pneumonia; our dependence on the success of solithromycin and fusidic acid; our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our ability to produce and sell any approved products and the price we are able to realize for those products; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.


CHAPEL HILL, N.C., June 02, 2017 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that researchers will present data from eight studies of fusidic acid and solithromycin at the American Society for Microbiology (ASM) 2017 meeting in New Orleans, LA. “We are pleased that ASM has recognized data informing important potential uses of solithromycin and fusidic acid with two late breakers and eight overall presentations at the conference,” said David Oldach, M.D., chief medical officer of Cempra. In addition, Toyama, Cempra’s partner for solithromycin in Japan, and JMI Laboratories, an independent laboratory conducting work supported by Cempra, will present the following abstracts: Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases. Cempra's two lead product candidates are currently in advanced clinical development. Solithromycin has been evaluated in two phase 3 clinical trials for community-acquired bacterial pneumonia (CABP). Cempra is currently seeking approval for CABP for both intravenous and oral capsule formulations from the U.S. Food and Drug Administration. Solithromycin is licensed to strategic commercial partner Toyama Chemical Co., Ltd. (Toyama), a subsidiary of FUJIFILM Holdings Corporation, for certain exclusive rights in Japan. Cempra is contracted with BARDA for the development of solithromycin for pediatric use and has commenced enrollment in a global phase 2/3 trial to evaluate the safety and efficacy of solithromycin versus standard of care antibiotics in children and adolescents from two months to 17 years of age. Solithromycin is also in development for uncomplicated urogenital urethritis caused by Neisseria gonorrhoeae or chlamydia. Fusidic acid is Cempra's second product candidate, which has completed a phase 3 trial comparing fusidic acid to linezolid in patients with acute bacterial skin and skin structure infections (ABSSSI). Cempra also has an ongoing exploratory study of fusidic acid for chronic oral treatment of refractory infections in bones and joints. Both products seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. Cempra is also studying solithromycin for ophthalmic conditions and has synthesized novel macrolides for non-antibiotic uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Cempra was founded in 2006 and is headquartered in Chapel Hill, N.C. For additional information about Cempra please visit www.cempra.com. Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: results of our and our strategic commercial partners' preclinical studies and clinical trials are not predictive of results from subsequent clinical trials for any possible therapy; our ability to obtain FDA and foreign regulatory approval of solithromycin as a treatment for community acquired bacterial pneumonia; our dependence on the success of solithromycin and fusidic acid; our and our strategic commercial partners' ability to obtain FDA and foreign regulatory approval of our product candidates; the costs, sources of funds, enrollment, timing, regulatory review and results of our studies and clinical trials and those of our strategic commercial partners; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including solithromycin and fusidic acid; our ability to commercialize and launch, whether on our own or with a strategic partner, any product candidate that receives regulatory approval; our ability to produce and sell any approved products and the price we are able to realize for those products; innovation by our competitors; and our ability to stay abreast of and comply with new or modified laws and regulations that currently apply or become applicable to our business. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.


News Article | June 5, 2017
Site: www.sciencedaily.com

Findings from a study that looked at susceptibility trends of Staphylococcus aureus in U.S. hospital patients showed that key antibiotics used to treat the bacteria became more active over the course of the study, a rare occurrence. Researchers at JMI Laboratories evaluated susceptibility trends of antibiotics from 2009 to 2015 by testing clinical isolates from medical centers across the U.S. The research is presented on June 4th at the ASM Microbe conference in New Orleans, Louisiana. "Results showed that S. aureus' rates of resistance to certain antibiotics decreased over time, which isn't often seen," said presenting author Helio S. Sader, M.D., Ph.D., Senior Director, Microbiology & Surveillance at JMI Laboratories. The rates of S. aureus being resistant to oxacillin (MRSA) decreased from 47.2% in 2009 to 43.6% in 2015, and more recent data from this program showed a further decrease to 42.2% in 2016. Resistance to other antibiotics, such as levofloxacin, clindamycin, and erythromycin, also showed some decrease during the same period, whereas susceptibility to ceftaroline, trimethoprim-sulfanethoxazole, and tetracycline remained stable. Furthermore, ceftaroline remained very active against methicillin-resistant S. aureus (MRSA) (97.2% susceptible) and methicillin-susceptible S. aureus (100.0% susceptible) with no marked variations or trends during the study period. One important result is that S. aureus resistance to daptomycin, linezolid, vancomycin, and tigecycline remained extremely rare with no sign of increasing. Researchers tested a total of 19,036 clinical isolates from 42 U.S. medical centers to determine how susceptible S. aureus would be to antibiotic agents. JMI used broth microdilution methods, the gold-standard method, to test susceptibility. Medical center staff participating in the AWARE program followed a common study protocol to send collected bacterial isolates to JMI Laboratories to test how susceptible the isolates were to specific antibiotics. During the late 1990s, people in the U.S. started to become infected with MRSA outside hospitals, in community settings, and this community-acquired MRSA (CA-MRSA) spread rapidly. CA-MRSA greatly changed how clinicians treated some community-acquired infections, especially skin and soft tissue infections and respiratory tract infections in children. Community-acquired MRSA was susceptible to trimethoprim-sulfamethoxazole, clindamycin, and tetracycline, and the bacteria was less susceptible to erythromycin and fluoroquinolones; however, CA-MRSA clones evolved and became more resistant to other antibiotic agents. "The prevalence of the main S. aureus clone causing community-acquired and healthcare-associated infections in many parts of the U.S. seems to be decreasing in some areas," said Dr. Sader, "A prevalence decrease may change the antimicrobial resistance profiles of S. aureus, emphasizing the importance of monitoring this organism through large resistance surveillance programs."


News Article | June 5, 2017
Site: www.eurekalert.org

New Orleans, LA - June 4, 2017 - Findings from a study that looked at susceptibility trends of Staphylococcus aureus in U.S. hospital patients showed that key antibiotics used to treat the bacteria became more active over the course of the study, a rare occurrence. Researchers at JMI Laboratories evaluated susceptibility trends of antibiotics from 2009 to 2015 by testing clinical isolates from medical centers across the U.S. The research is presented on June 4th at the ASM Microbe conference in New Orleans, Louisiana. "Results showed that S. aureus' rates of resistance to certain antibiotics decreased over time, which isn't often seen," said presenting author Helio S. Sader, M.D., Ph.D., Senior Director, Microbiology & Surveillance at JMI Laboratories. The rates of S. aureus being resistant to oxacillin (MRSA) decreased from 47.2% in 2009 to 43.6% in 2015, and more recent data from this program showed a further decrease to 42.2% in 2016. Resistance to other antibiotics, such as levofloxacin, clindamycin, and erythromycin, also showed some decrease during the same period, whereas susceptibility to ceftaroline, trimethoprim-sulfanethoxazole, and tetracycline remained stable. Furthermore, ceftaroline remained very active against methicillin-resistant S. aureus (MRSA) (97.2% susceptible) and methicillin-susceptible S. aureus (100.0% susceptible) with no marked variations or trends during the study period. One important result is that S. aureus resistance to daptomycin, linezolid, vancomycin, and tigecycline remained extremely rare with no sign of increasing. Researchers tested a total of 19,036 clinical isolates from 42 U.S. medical centers to determine how susceptible S. aureus would be to antibiotic agents. JMI used broth microdilution methods, the gold-standard method, to test susceptibility. Medical center staff participating in the AWARE program followed a common study protocol to send collected bacterial isolates to JMI Laboratories to test how susceptible the isolates were to specific antibiotics. During the late 1990s, people in the U.S. started to become infected with MRSA outside hospitals, in community settings, and this community-acquired MRSA (CA-MRSA) spread rapidly. CA-MRSA greatly changed how clinicians treated some community-acquired infections, especially skin and soft tissue infections and respiratory tract infections in children. Community-acquired MRSA was susceptible to trimethoprim-sulfamethoxazole, clindamycin, and tetracycline, and the bacteria was less susceptible to erythromycin and fluoroquinolones; however, CA-MRSA clones evolved and became more resistant to other antibiotic agents. "The prevalence of the main S. aureus clone causing community-acquired and healthcare-associated infections in many parts of the U.S. seems to be decreasing in some areas," said Dr. Sader, "A prevalence decrease may change the antimicrobial resistance profiles of S. aureus, emphasizing the importance of monitoring this organism through large resistance surveillance programs." This investigation was performed by JMI Laboratories (North Liberty, Iowa, USA). The data used in this investigation was generated as part of the Assessing Worldwide Antimicrobial Resistance and Evaluation (AWARE) Program, which is sponsored by Allergan. ASM Microbe, the annual meeting of the American Society for Microbiology, covers the complete spectrum of microbiology, featuring innovative science, world class speakers, and scientists from around the globe with more than 500 sessions and over 575 speakers. ASM Microbe is held in New Orleans, Louisiana from June 1 -5, 2017. The American Society for Microbiology is the largest single life science society, composed of over 50,000 scientists and health professionals. ASM's mission is to promote and advance the microbial sciences. ASM advances the microbial sciences through conferences, publications, certifications and educational opportunities. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.


News Article | June 5, 2017
Site: www.sciencedaily.com

Findings from a study that looked at susceptibility trends of Staphylococcus aureus in U.S. hospital patients showed that key antibiotics used to treat the bacteria became more active over the course of the study, a rare occurrence. Researchers at JMI Laboratories evaluated susceptibility trends of antibiotics from 2009 to 2015 by testing clinical isolates from medical centers across the U.S. The research is presented on June 4th at the ASM Microbe conference in New Orleans, Louisiana. "Results showed that S. aureus' rates of resistance to certain antibiotics decreased over time, which isn't often seen," said presenting author Helio S. Sader, M.D., Ph.D., Senior Director, Microbiology & Surveillance at JMI Laboratories. The rates of S. aureus being resistant to oxacillin (MRSA) decreased from 47.2% in 2009 to 43.6% in 2015, and more recent data from this program showed a further decrease to 42.2% in 2016. Resistance to other antibiotics, such as levofloxacin, clindamycin, and erythromycin, also showed some decrease during the same period, whereas susceptibility to ceftaroline, trimethoprim-sulfanethoxazole, and tetracycline remained stable. Furthermore, ceftaroline remained very active against methicillin-resistant S. aureus (MRSA) (97.2% susceptible) and methicillin-susceptible S. aureus (100.0% susceptible) with no marked variations or trends during the study period. One important result is that S. aureus resistance to daptomycin, linezolid, vancomycin, and tigecycline remained extremely rare with no sign of increasing. Researchers tested a total of 19,036 clinical isolates from 42 U.S. medical centers to determine how susceptible S. aureus would be to antibiotic agents. JMI used broth microdilution methods, the gold-standard method, to test susceptibility. Medical center staff participating in the AWARE program followed a common study protocol to send collected bacterial isolates to JMI Laboratories to test how susceptible the isolates were to specific antibiotics. During the late 1990s, people in the U.S. started to become infected with MRSA outside hospitals, in community settings, and this community-acquired MRSA (CA-MRSA) spread rapidly. CA-MRSA greatly changed how clinicians treated some community-acquired infections, especially skin and soft tissue infections and respiratory tract infections in children. Community-acquired MRSA was susceptible to trimethoprim-sulfamethoxazole, clindamycin, and tetracycline, and the bacteria was less susceptible to erythromycin and fluoroquinolones; however, CA-MRSA clones evolved and became more resistant to other antibiotic agents. "The prevalence of the main S. aureus clone causing community-acquired and healthcare-associated infections in many parts of the U.S. seems to be decreasing in some areas," said Dr. Sader, "A prevalence decrease may change the antimicrobial resistance profiles of S. aureus, emphasizing the importance of monitoring this organism through large resistance surveillance programs."


Ceftaroline fosamil has recently received US Food and Drug Administration approval for treatment of acute bacterial skin/skin structure infections (SSSIs), including those caused by methicillin-resistant Staphylococcus aureus and community-acquired bacterial pneumonia for pediatric patients ≥2 months old. We evaluated the potency and spectrum of ceftaroline and comparators when tested against community-acquired respiratory tract infection (CARTI) and SSSI pathogens from pediatric patients. A total of 3141 consecutive, unique pediatric patient isolates of clinical significance (1460 CARTI and 1681 SSSI isolates) were collected from 29 US medical centers and tested for susceptibility to ceftaroline and comparators by broth microdilution methods. The organism collection included Streptococcus pneumoniae (n = 754), Haemophilus influenzae (487), S. aureus (1399), β-hemolytic streptococci (214), Enterobacteriaceae (112), Pseudomonas aeruginosa (58), Klebsiella spp. (39), Escherichia coli (26) and miscellaneous other bacteria (52). Susceptibility results were analyzed according to patient age as follows: ≤1, 2-5, 6-12 and 13-17 years old. Overall, 99%-100% of Gram-positive isolates and H. influenzae were susceptible to ceftaroline according to Clinical and Laboratory Standards Institute clinical breakpoint criteria. Ceftaroline exhibited potent in vitro activity against bacterial pathogens from CARTI and SSSI recently (2012-2014) collected from pediatric patients in US medical centers. Ceftaroline was particularly active against methicillin-resistant S. aureus from SSSI ([minimum inhibitory concentration for 50% and 90% of isolates (MIC50/90,)] and ceftriaxone-nonsusceptible isolates of S. pneumoniae from CARTI (MIC50/90, 0.25/0.5 μg/mL; 98.3% susceptible).

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