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News Article | May 10, 2017
Site: www.prnewswire.com

The IMPALA study is a randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of Molgradex with placebo in patients with PAP. The study, which began enrolling patients in Europe and Japan last year, will be expanded to enroll a total of 90 patients, half of which have already been enrolled. Patient enrollment is expected to be completed by the first quarter of 2018, and top line data is expected to be available by the fourth quarter of 2018. "Molgradex is a unique product that directly addresses the disease mechanism causing PAP – an autoimmune blockade of a naturally occurring signaling protein, GM-CSF, which is required to clear excess surfactant from the lungs," said Dr. Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, Cincinnati Children's Hospital Medical Center, and Director of the NCATS-NHLBI Rare Lung Diseases Clinical Research Consortium. "PAP is a debilitating lung disease with a high clinical need for an effective medicinal treatment to reduce or eliminate the need for whole lung lavage. Inhaled GM-CSF restores the ability of lung cells to clear surfactant. Based on an increasing body of literature and clinical experience of explorative use of inhaled GM-CSF, I and my colleagues treating PAP patients worldwide are very optimistic about the potential of Molgradex as a truly transformative treatment option in PAP." The primary endpoint in the IMPALA study will remain the absolute change from baseline in arterial-alveolar oxygen gradient, a measure of patient's oxygenation status, following 24 weeks of treatment. In addition, the FDA will focus its review on three key secondary endpoints that will be assessed to show improvement in clinical symptoms and function, including six-minute walk distance, St. George's respiratory questionnaire, and the time to need of whole lung lavage. Patients are randomized to receive treatment for up to 24 weeks in one of three treatment arms: 1) Molgradex 300 µg administered once daily, 2) Molgradex 300 µg and matching placebo administered daily in 7-day intermittent cycles of each, or 3) inhaled placebo administered once daily. About Pulmonary Alveolar Proteinosis (PAP) PAP is a rare lung disease which is characterized by the build-up of lung surfactant in the alveoli, or air sacs, of the lungs. The surfactant consists of proteins and lipids, and is an important physiological substance that lines the inside of the alveoli to prevent the lungs from collapsing. In a healthy lung, the old and inactivated surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by GM-CSF to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering the macrophages unable to perform their tasks. As a result, an excess of surfactant accumulates in the alveoli, causing obstruction of gas exchange, and patients start to experience shortness of breath, and decreased exercise tolerance. Patients may also experience chronic cough, as well as episodes of fever, chest pain, or coughing blood, especially if secondary lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for lung transplant. About Molgradex Molgradex, an inhaled formulation of recombinant human GM-CSF, is being developed for the treatment of autoimmune pulmonary alveolar proteinosis, or PAP. Savara is also pursuing indication expansion, with priority on the development of Molgradex in rare infectious lung diseases, where stimulation of the innate immune system has the potential to improve clinical outcomes. The Company expects to announce details related to its indication expansion strategy by the third quarter of 2017. Molgradex has been granted Orphan Drug Designation for the treatment of PAP in the United States and the European Union. About Savara Savara Inc. is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases. Savara's pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF, in Phase 3 development, AeroVanc, an inhaled vancomycin in preparation for a Phase 3 study, and Aironite, an inhaled nebulized sodium nitrite in Phase 2 development. Savara's strategy involves expanding its pipeline of best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara's management team has significant experience in orphan drug development and pulmonary medicine, in identifying unmet needs, creating and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma) Forward Looking Statements  Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. Such statements include, but are not limited to, statements regarding the Molgradex development strategy, potential to considerably expedite the approval of the product in the U.S., that Molgradex can offer a game changing treatment alternative, patient enrollment expected to be completed by the first quarter of 2018, and top line data expected to be available by the fourth quarter of 2018 and expecting to announce details related to its indication expansion strategy by the third quarter of 2017. Savara may not actually achieve any of the matters referred to in such forward looking statements, and you should not place undue reliance on these forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment in a timely manner, the timing and ability of Savara to raise additional equity capital to fund continued operations; the ability to successfully develop Savara's product candidates, and the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates that are safe and effective for use as human therapeutics. Risks and uncertainties facing Savara are described more fully in Savara's filings with the Securities and Exchange Commission including the Form 8-K filed on April 27, 2017, other filings on Form 8-K, the Annual Report on Form 10-K for the fiscal year ended December 31, 2016, the Quarterly Report on Form 10-Q for the quarter ended March 31 2017 and the Registration Statement on Form S-4 related to the Mast/Savara merger. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes any obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/savara-announces-expedited-us-molgradex-development-strategy-300454877.html


News Article | May 11, 2017
Site: www.prweb.com

Nimblify Inc., a clinical trials technology company, will have a strong presence at MAGI's Clinical Research Conference on May 21-24, 2017 in Philadelphia, PA at the Loews Hotel. Nimblify is a Gold Sponsor of the event, along with its parent company, Forte Research Systems, and will have significant involvement throughout the conference. Nimblify Founder & CEO, Shree Kalluri, will help present MAGI's Award for Excellence in Site Payments, powered by Nimblify. The inaugural awards recognize and congratulate the sponsors that pay sites promptly. Forte’s customers contributed data for hundreds of studies with nearly 32,000 payment records, and Nimblify curated and analyzed the data. The ceremony takes place on Monday, May 22 during the opening of the conference, and will announce the winner and runner-up. On Sunday, May 21 from 9 am-12 pm, Orla Mester, Senior Vice President of Operations at Forte and Nimblify will host the workshop, “Develop a Technology Road Map for Your Research Site” focused on helping attendees develop a plan for technology implementation at the site level. This interactive workshop equips attendees with questions to ask and answer when determining their technology needs – from hosting and security to regulatory compliance – to help ensure successful system implementation and user adoption. Additionally, on Tuesday, May 23 from 9:30-10:15 am, Laura Hilty, Vice President of Product Management at Nimblify will present the session, “Sponsor Payments to Sites: How Long Does it Really Take?” In this session, co-presented by DrugDev, Hilty shares new data on payment collection timelines, including the analysis and results of the current state of the industry, performed by Dr. Wendy Tate, Director of Data Analytics at Nimblify. This talk also uncovers how sponsors can accelerate payments to sites and ideas to improve payment processes. Attendees can pick up a free, print edition of the eBook, “Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials” and learn more about Nimblify and Forte’s software solutions at their booth in the exhibit hall. For more information, please email info(at)nimblify(dot)com. About Nimblify Nimblify, Inc. is a clinical trials technology company dedicated to improving trial outcomes by connecting stakeholders in clinical research in innovative ways. Nimblify created Participant Payments, a patient-centric payment system, and hosts Site Benchmarks, a free award-winning metrics and comparative analytics tool for sites. Nimblify also collaboratively and continuously develops Research Insights, a cloud-based analytics platform with actionable information, and hosts the Nimblify Marketplace, which provides business operations solutions for sites to save time, reduce costs and ensure quality. Spun out of Forte Research Systems in August 2015, Nimblify is a privately held company and is headquartered in Madison, Wisconsin.


In addition, systolic blood pressure (SBP) in the subset of type 1 diabetic patients in the study with baseline hypertension (SBP ≥130 mmHg) was reduced by 9.9 mmHg and 11.0 mmHg at week 12 when treated with 200 mg and 400 mg of sotagliflozin, respectively, compared to a reduction of 4.4 mmHg on placebo (p=0.017 and p=0.003 for the 200 mg and 400 mg doses, respectively). Notably, the outcome on every secondary endpoint favored sotagliflozin over placebo, with results for the 400 mg dose having achieved statistical significance for all six secondary endpoints (results for the first two secondary endpoints were also statistically significant for the 200 mg dose): Sotagliflozin was generally well tolerated during the 28-week extension period, with rates of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to AEs that were consistent with rates seen in the initial 24-week treatment period. The rate of severe hypoglycemia was the same or lower for the sotagliflozin arms than placebo during the 28-week extension period (10 patients (4.3%) for placebo, compared to 10 (4.2%) and 6 (2.5%) for sotagliflozin 200 mg and 400 mg, respectively), and was slightly lower overall than the rate seen in the initial 24-week treatment period. The rate of diabetic ketoacidosis (DKA) during the 28-week extension period was slightly higher than the rate seen in the initial 24-week treatment period for placebo (one patient, 0.4%) and the 200 mg dose arm (6, 2.5%) and lower for the 400 mg dose arm (3, 1.3%). "Sotagliflozin's ability to improve both A1C and other measures of health such as body weight and blood pressure holds promise for addressing important areas of need in type 1 diabetes, and the additional inTandem1 results announced today highlight the differentiated profile of sotagliflozin in the type 1 diabetes landscape," said Lonnel Coats, Lexicon's president and chief executive officer. "In the coming weeks, we look forward to the outcome of inTandem3, with its 'net benefit' primary efficacy endpoint that measures the proportion of patients achieving an A1C of less than 7% without a severe hypoglycemia or DKA event. We saw favorable results on the same endpoint in inTandem1 and inTandem2 and remain confident about replicating these data in inTandem3." "Type 1 diabetes is a tough disease for patients and their providers to take care of. The potential of sotagliflozin to lower blood glucose and favorably affect body weight and blood pressure is tremendous," said John Buse, M.D., Ph.D., lead investigator of inTandem1 and Professor of Medicine, Chief of the Division of Endocrinology and Metabolism, Director of the Diabetes Care Center, and Executive Associate Dean for Clinical Research at the University of North Carolina School of Medicine. "If approved, sotagliflozin could be an important oral therapy for individuals with type 1 diabetes while on insulin." The Phase 3 study known as inTandem1 was a double-blind, placebo-controlled, multi-center study of 793 patients in the U.S. and Canada with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured. The mean baseline A1C level at the time of randomization after the six-week optimization period was 7.6% for all three dose arms. The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial had a double-blind long-term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 268 patients in the placebo arm, 263 patients in the 200mg dose arm, and 262 patients in the 400 mg dose arm. The overall mean placebo adjusted A1C reduction was 0.35% in the 200 mg dose arm (p<0.001) and 0.41% in the 400mg dose arm (p<0.001) over the initial 24-week treatment period. The A1C benefit achieved with sotagliflozin was sustained over the full 52-week duration of the study for both the 200 mg and 400 mg doses (p<0.001 at week 52). Sotagliflozin was generally well tolerated during the study. Across all three dose arms (placebo, 200mg, 400mg), over the full 52 weeks of treatment, the incidences of AEs were 80.6%, 81.7% and 79.8%, respectively; the incidences of SAEs were 7.5%, 10.3% and 11.1%, respectively; and discontinuations due to AEs were 4.1%, 4.9% and 6.5%, respectively. There was one death in the study in the placebo arm and no deaths in either sotagliflozin arm. Two primary safety concerns for patients with type 1 diabetes are severe hypoglycemia and DKA. The number of patients with severe hypoglycemia events during the full 52 weeks of treatment was 26 (9.7%), 17 (6.5%), and 17 (6.5%) in the placebo, 200 mg and 400 mg dose arms, respectively. The number of patients with DKA events during the full 52 weeks of treatment was 1 (0.4%), 9 (3.4%), and 11 (4.2%) in the placebo, 200 mg and 400 mg dose arms, respectively. Lexicon is conducting another, similar pivotal Phase 3 clinical trial predominantly in Europe (inTandem2), from which top-line, primary efficacy endpoint and safety data at 24 weeks has previously been reported and additional data from secondary endpoints as well as pooled continuous glucose monitoring (CGM) results from inTandem1 and inTandem2 are expected in the third quarter of 2017. Lexicon is conducting a third, global Phase 3 clinical trial, inTandem3, studying approximately 1,400 type 1 diabetes patients treated with sotagliflozin 400mg once daily or placebo on a background of any insulin therapy, but without insulin optimization prior to randomization. Top-line data from inTandem3 is expected in the coming weeks. Discovered using Lexicon's unique approach to gene science, sotagliflozin is a first-in-class, oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin has been shown in a Phase 2 study to improve glycemic control in people with type 1 diabetes while reducing their need for mealtime insulin. Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and retains an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan). Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its recently-launched product for carcinoid syndrome diarrhea, XERMELO™ (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com. This press release contains "forward-looking statements," including statements relating to Lexicon's and its licensees' clinical development of and regulatory filings for sotagliflozin and the results and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that clinical studies of sotagliflozin may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin in accordance with Lexicon's currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other potential drug candidates, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/lexicon-pharmaceuticals-reports-additional-positive-data-from-pivotal-intandem1-phase-3-study-for-sotagliflozin-in-patients-with-type-1-diabetes-300455820.html


News Article | May 11, 2017
Site: globenewswire.com

HOUSTON, May 11, 2017 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc. (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the first quarter ended March 31, 2017 and provided an update on recent corporate developments. “Our ongoing Phase 2 trial of prexigebersen for the treatment of acute myeloid leukemia (AML) is advancing according to plan and we remain on track to complete our 19 patient interim analysis by the end of this year,” said Peter Nielsen, President and CEO of Bio-Path Holdings. “Additionally, we were honored to welcome Dr. William Hahne to our team as Vice President of Clinical Research. His extensive experience directing clinical research programs, curating product pipelines, and liaising with regulatory agencies will be critical as we see our next candidate, BP1002, into the clinic for the treatment of lymphoma.” Financial Results for the First Quarter Ended March 31, 2017 The Company reported a net loss of $0.4 million, or $0.01 per share, for the three months ended March 31, 2017, compared to a net loss of $1.9 million, or $0.02 per share, for the same period in 2016.  The decrease was primarily due to a non-cash change in the fair value of the Company’s warranty liability during the period of $1.6 million. Research and development expenses for both the three months ended March 31, 2017 and March 31, 2016, were $1.0 million. General and administrative expenses for the three months ended March 31, 2017 increased to $1.0 million, compared to $0.8 million for the three months ended March 31, 2016 primarily due to increased stock-based compensation expense during the period. Change in fair value of the Company’s warrant liability for the three months ended March 31, 2017 resulted in non-cash income of $1.6 million.  The company did not have the warrant liability in the comparable period for 2016. As of March 31, 2017, the Company had cash of $7.1 million, compared to $9.4 million at December 31, 2016.  Net cash used in operating activities for the three months ended March 31, 2017 was $1.8 million compared to $2.4 million for the comparable period in 2016.  Net cash used in investing activities for the three months ended March 31, 2017 was $0.4 million. Bio-Path Holdings will host a conference call today to review these first quarter 2017 financial results, as well as to provide a general update on the Company, via a webcast and conference call at 8:30 a.m. ET. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229- 8838 (international) and refer to the conference ID number 11686674. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com. Bio-Path is a biotechnology company focused on developing therapeutic products utilizing DNAbilize™, its proprietary liposomal delivery and antisense technology, to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, liposomal Grb2 antisense), is in a Phase II study for blood cancers and in preclinical studies for solid tumors. Bio-Path’s second drug candidate, also a liposomal antisense drug, is ready for the clinic where it will be evaluated in lymphoma and solid tumors. For more information, please visit the Company's website at http://www.biopathholdings.com.


News Article | May 10, 2017
Site: www.prweb.com

The Orthopaedic Research and Education Foundation (OREF) and the National Stem Cell Foundation (NSCF) announced today they have partnered to fund a second adult stem cell research grant, the OREF Clinical Research Grant in Cellular Therapy. As with their co-funded grant in 2014, this collaboration will allow both organizations to direct significant funding to stem cell research, which is expected to play a key role in the future of orthopaedic medicine. The grant will provide up to $800,000 over a three-year period, making it the largest grant ever offered by OREF. According to the American Academy of Orthopaedic Surgeons, stem cell therapies hold great promise for the treatment of many common musculoskeletal conditions including bone fractures and nonunions, articular cartilage damage and ligament and tendon ruptures and tears. Dr. Paula Grisanti, Chairman & CEO of NSCF said, “The National Stem Cell Foundation is delighted to partner with OREF in funding research projects with this kind of promise. It is our goal to fund collaborations that will accelerate the development and availability of stem cell therapies with the greatest potential for immediate impact.” “The OREF mission is about coming together to support innovative and promising orthopaedic research. This new program with the National Stem Cell Foundation is a powerful illustration of what we can achieve when we combine our resources, experience and creativity for the good of our patients and the practice of orthopaedics,” stated David G. Lewallen, MD, OREF Board President. About the National Stem Cell Foundation The National Stem Cell Foundation is a charitable 501(c)(3) organization that funds adult stem cell and regenerative medicine research to accelerate treatment options, advocates for patients participating in clinical trials and supports STEM education to inspire the next generation of researchers and scientists nationwide. For more information, please visit http://www.nationalstemcellfoundation.org About the Orthopaedic Research and Education Foundation The Orthopaedic Research and Education Foundation is a charitable 501(c)(3) organization committed to improving lives by supporting excellence in orthopaedic research. OREF is dedicated to being the leader in supporting research that improves function, eliminates pain and restores mobility, and is the premiere orthopaedic organization funding research across all specialties. A list of research and funding priorities is available at oref.org/grants or follow @oreftoday on Twitter.


News Article | May 12, 2017
Site: www.prweb.com

Mediaplanet today announces the launch of this May’s edition of “Clinical Trials.” This campaign will educate doctors, physicians, nurses, and allied healthcare professionals on the benefits of conducting a clinical trial, while honing in on the proper and most effective ways to improve the process, ultimately leading to an increase in completed trials, treatments, and live saving discoveries. Only around 32% of drugs have a probability into making it to phase 3 trials, and only 1 in 10 drugs actually make it to the market. This means that the time, effort, and dollars that are being spent (800k-1.4B) for clinical trials are not panning out as plan, which causes hesitation in their conduction. There are several factors leading to the incompletion of a clinical trial. Ensuring the clinical trial is planned properly, leads to a higher success rate of the trial.The need for more participants and better planned clinical trials is crucial. The print component of “Clinical Trials” is distributed within today’s edition of USA Today in New York, Boston, Washington/Baltimore, Phoenix, and the Carolinasmarkets, with a circulation of approximately 250,000 copies and an estimated readership of 750,000. The digital component is distributed nationally, through a vast social media strategy, and across a network of top news sites and partner outlets. To explore the digital version of the campaign, click here. Cancer survivor and clinical trial activist T.J. Share graces the cover of the print publication. Through an exclusive interview on the interior, T.J. shares his story on how participating in clinical trials saved his life. T.J. talks about the power of clinical trials and how others can educate themselves on these life-saving studies. T.J. encourages all to consider clinical trials as an option, he says “when it comes down to it, we are all patients at some point, so we should know what all of our options are before making a decisions.” This campaign was made possible with the support of the Center for Information on Clinical Research Participation (CISCRP), Association of Clinical Research Professionals (ACRP), Coalition for Clinical Trials Awareness(CCTA), Clinical Trials Transformation Initiative (CTTI), QST Consultations, TransCelerate BioPharma Inc., Biogen, Merck, Pfizer, Janssen, CureForward, and PerkinElmer. About Mediaplanet  Mediaplanet specializes in the creation of content marketing campaigns covering a variety of industries. We tell meaningful stories that educate our audience and position our clients as solution providers. Our unique ability to pair the right leaders with the right readers, through the right platforms, has made Mediaplanet a global content marketing powerhouse. Our award-winning stories have won the hearts of countless readers while serving as a valuable platform for brands and their missions. Just call us storytellers with a purpose. Please visit http://www.mediaplanet.com for more on who we are and what we do.


News Article | May 11, 2017
Site: globenewswire.com

HOUSTON, May 11, 2017 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc. (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize™ liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the first quarter ended March 31, 2017 and provided an update on recent corporate developments. “Our ongoing Phase 2 trial of prexigebersen for the treatment of acute myeloid leukemia (AML) is advancing according to plan and we remain on track to complete our 19 patient interim analysis by the end of this year,” said Peter Nielsen, President and CEO of Bio-Path Holdings. “Additionally, we were honored to welcome Dr. William Hahne to our team as Vice President of Clinical Research. His extensive experience directing clinical research programs, curating product pipelines, and liaising with regulatory agencies will be critical as we see our next candidate, BP1002, into the clinic for the treatment of lymphoma.” Financial Results for the First Quarter Ended March 31, 2017 The Company reported a net loss of $0.4 million, or $0.01 per share, for the three months ended March 31, 2017, compared to a net loss of $1.9 million, or $0.02 per share, for the same period in 2016.  The decrease was primarily due to a non-cash change in the fair value of the Company’s warranty liability during the period of $1.6 million. Research and development expenses for both the three months ended March 31, 2017 and March 31, 2016, were $1.0 million. General and administrative expenses for the three months ended March 31, 2017 increased to $1.0 million, compared to $0.8 million for the three months ended March 31, 2016 primarily due to increased stock-based compensation expense during the period. Change in fair value of the Company’s warrant liability for the three months ended March 31, 2017 resulted in non-cash income of $1.6 million.  The company did not have the warrant liability in the comparable period for 2016. As of March 31, 2017, the Company had cash of $7.1 million, compared to $9.4 million at December 31, 2016.  Net cash used in operating activities for the three months ended March 31, 2017 was $1.8 million compared to $2.4 million for the comparable period in 2016.  Net cash used in investing activities for the three months ended March 31, 2017 was $0.4 million. Bio-Path Holdings will host a conference call today to review these first quarter 2017 financial results, as well as to provide a general update on the Company, via a webcast and conference call at 8:30 a.m. ET. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229- 8838 (international) and refer to the conference ID number 11686674. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com. Bio-Path is a biotechnology company focused on developing therapeutic products utilizing DNAbilize™, its proprietary liposomal delivery and antisense technology, to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, liposomal Grb2 antisense), is in a Phase II study for blood cancers and in preclinical studies for solid tumors. Bio-Path’s second drug candidate, also a liposomal antisense drug, is ready for the clinic where it will be evaluated in lymphoma and solid tumors. For more information, please visit the Company's website at http://www.biopathholdings.com.


"The EMU program in Clinical Research Administration was one of the first academic programs developed in this discipline and is well known and highly regarded globally," Sonstein said. "Since 1996, our graduates have been employed both locally, throughout the U.S. and around the world." The Healthcare Management Degree Guide said in its description that "Eastern Michigan University's accredited MS in clinical research might be one of the best programs for working adults who already have an established career in a research facility." "EMU expects – and then builds on – a certain level of prior education and relevant work experience," the guide noted. "By assuming this baseline of industry knowledge, EMU is able to offer an accelerated program; students can complete all required courses (including the capstone research thesis) in as little as 24 months with part-time enrollment." The ranking of the program, located in EMU's College of Health and Human Services, was based on information gathered in part from the National Center for Education Statistics and the Consortium of Academic Programs in Clinical Research. "We then ranked the schools based on expertise and involvement in the field, career training and curricular relevance, accessibility to students, and application of knowledge," said Amanda Ginder, head of online relations for the guide. Ginder said that Healthcare Management Degree Programs knows that many private companies – as well as government agencies, like the FDA – need clinical researchers and managers to act as watchdogs for the new medicines, treatments, and diagnostic products that are hitting the market every day. "Graduating with a master's degree in research and clinical research management can position you for any number of financially rewarding career paths, she said. See the Healthcare Management Degree Guide website for a list of top programs, including Eastern's No. 1 ranking. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/eastern-michigan-university-masters-program-in-clinical-research-administration-ranked-best-in-the-country-300456022.html


The potentially debilitating condition known as gastroparesis, which results when stomach muscle contractions function abnormally, causing the stomach's contents to empty too slowly, affects as many as five million Americans. Often the cause of the disease is unknown and the underlying bioelectrical activity that initiates and coordinates gastric contractions, known as slow waves, is not fully understood. However, a first-of-its-kind portable wireless device developed by an NYIT-led research team can monitor stomach motility to enable physicians to measure and ultimately better understand slow wave activity. Aydin Farajidavar, Ph.D., assistant professor of Electrical and Computer Engineering at New York Institute of Technology (NYIT) School of Engineering and Computing Sciences, today presented results captured from his study - the first portable wireless device developed and validated in clinical settings to document gastric contractions in patients suffering from gastroparesis. Farajidavar's work, "A Novel System and Methodology for Continuous Ambulatory Monitoring of Gastric Slow Waves," was selected as a Poster of Distinction for presentation during Digestive Disease Week 2017. Further, it was rated in the top 10 percent of all AGA (American Gastroenterological Association) abstracts selected for poster presentation at DDW, the world's largest gathering of physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. "From an engineering perspective, we know that the wireless device works effectively; the system and methodology we developed enable physicians to document slow waves in patients with gastroparesis. The system can help us to better understand the effect of electrical stimulation on gastric contractions and to examine a variety of hypotheses about the gastric activity," Farajidavar said. This research project is part of an ongoing effort in NYIT School of Engineering and Computing Sciences' Integrated Medical Systems laboratory to develop devices to better diagnose gastrointestinal disorders and diseases. The team's developed system consists of a portable module that can wirelessly transmit data to a back-end receiver connected to a PC to display and store for off-line analysis. The device can also log data on a memory card for long-term monitoring. In addition to three NYIT graduate engineering students and a postdoctoral fellow, Farajidavar's research team includes Thomas L. Abell, M.D. and Abigail Stocker, M.D., world-class gastroenterologists from University of Louisville Medical Center, which is participating in the National Institute of Diabetes and Digestive and Kidney Diseases-sponsored Gastroparesis Clinical Research Consortium. Each patient in the study, registered at University of Louisville under the care of Drs. Abell and Stocker, received two temporary electrodes and leads via endoscopy prior to having a permanent stimulator. One of the leads connected to the gastric stimulator; the other was connected to the developed recording system. The gastric waves were recorded wirelessly for short periods of time (approximately 10 minutes) before and after turning on the stimulator. Then each patient received the developed portable module, set in data-logging mode. Patients returned approximately five days later; in most cases, signals were recorded and analyzed successfully in terms of frequency and amplitudes. The frequency, amplitude, and shape of the short waves varied between the patients, and for each patient, varied depending on fed- and fast-states. "It is significant that the monitoring of the gastric activity was captured over the course of several days with patients in the trial utilizing portable devices. Now that activity in the stomach can be measured objectively, this ultimately could revolutionize how some digestive diseases can be diagnosed and treated," Farajidavar said. "This result could not have happened without the close collaboration between the NYIT engineering team and the University of Louisville physician team, and the patients who volunteered to participate in this study. I am privileged to have such hard-working students and postdoctoral fellow in my lab at NYIT." New York Institute of Technology (NYIT) offers 90 degree programs, including undergraduate, graduate, and professional degrees, in more than 50 fields of study, including architecture and design; arts and sciences; education; engineering and computing sciences; health professions; management; and osteopathic medicine. A non-profit independent, private institution of higher education, NYIT has 10,000 students attending campuses on Long Island and Manhattan, online, and at its global campuses. NYIT is guided by its mission to provide career-oriented professional education, offer access to opportunity to all qualified students, and support applications-oriented research that benefits the larger world. To date, 100,000 graduates have received degrees from NYIT. For more information, visit nyit.edu.


Williams G.P.,Clinical Research
European Journal of Cancer Prevention | Year: 2010

A detailed review of the literature was performed in a bid to identify the presence of a common link between specific hormone interactions and the increasing prevalence of global disease. The synergistic action of unopposed oestrogen and leptin, compounded by increasing insulin, cortisol and xeno-oestrogen exposure directly initiate, promote and exacerbate obesity, type 2 diabetes, uterine overgrowth, prostatic enlargement, prostate cancer and breast cancer. Furthermore these hormones significantly contribute to the incidence and intensity of anxiety and depression, Alzheimer's disease, heart disease and stroke. This review, in collaboration with hundreds of evidence-based clinical researchers, correlates the significant interactions these hormones exert upon the upregulation of p450 aromatase, oestrogen, leptin and insulin receptor function; the normal status quo of their binding globulins; and how adduct formation alters DNA sequencing to ultimately produce an array of metabolic conditions ranging from menopausal symptoms and obesity to Alzheimer's disease and breast and prostate cancer. It reveals the way that poor diet, increased stress, unopposed endogenous oestrogens, exogenous oestrogens, pesticides, xeno-oestrogens and leptin are associated with increased aromatase activity, and how its products, increased endogenous oestrogen and lowered testosterone, are associated with obesity, type 2 diabetes, Alzheimer's disease and oestrogenic disease. This controversial break-through represents a paradigm shift in medical thinking, which can prevent the raging pandemic of diabetes, obesity and cancer currently sweeping the world, and as such, it will reshape health initiatives, reduce suffering, prevent waste of government expenditure and effectively transform preventative medicine and global health care for decades. © 2010 Lippincott Williams & Wilkins, Inc.

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