News Article | March 2, 2017
(New York, NY - March 2, 2017) --Mount Sinai researchers have discovered that a rheumatoid arthritis drug can block a metabolic pathway that occurs in tumors with a common cancer-causing gene mutation, offering a new possible therapy for aggressive cancers with few therapeutic options, according to a study to be published in Cancer Discovery. Ramon Parsons, MD, PhD, Ward-Coleman Chair in Cancer Research and Chair of the Department of Oncological Sciences at the Icahn School of Medicine at Mount Sinai, led a team that studied how a mutation of the PTEN gene rewires a metabolic pathway in tumors, channeling increased amounts of the amino acid glutamine into the pathway, speeding up DNA production, and causing uncontrolled growth of the tumor. The team discovered that leflunomide, an oral rheumatoid arthritis drug approved by the U.S. Food and Drug Administration, blocks an enzyme in this pathway and damages the DNA created through the pathway, killing PTEN mutant cancer cells while leaving healthy cells untouched. Parsons and his team transplanted human breast cancer cells into mice to test leflunomide's efficacy. Leflunomide drastically reduced the breast cancer tumors in the mice. "Finding successful targeted therapies for cancer is a challenging but important goal in the face of insufficient treatment options," said Dr. Parsons, who discovered the PTEN gene. "Targeted therapies that are tumor-specific are much needed, and identifying changes based on specific tumor suppressor or oncogene alterations will facilitate this effort. Due to the high mutation rate of PTEN in cancer, the effects of PTEN could be at the heart of targeted therapy." This discovery has implications in aggressive cancers with the PTEN mutation and few treatment options such as triple negative breast cancer, prostate cancer, endometrial cancer, and glioblastoma, a brain cancer. Dr. Parsons hopes to create a clinical trial to further test leflunomide in patients with breast and colon cancer. This research was funded by NCI R01CA082783, R01CA155117, and P01CA97403 (R.P.), and partially supported by NIH grants 5P01CA120964 and 5P30CA006516 (J.MA.), and R01 GM041890 and the Breast Cancer Research Foundation (L.C.). The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services--from community-based facilities to tertiary and quaternary care. The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is on the "Honor Roll" of best hospitals in America, ranked No. 15 nationally in the 2016-2017 "Best Hospitals" issue of U.S. News & World Report. The Mount Sinai Hospital is also ranked as one of the nation's top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke's, and Mount Sinai West are ranked regionally. Mount Sinai's Kravis Children's Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report in "Best Children's Hospitals." For more information, visit http://www. or find Mount Sinai on Facebook, Twitter and YouTube.
News Article | February 21, 2017
CITY OF INDUSTRY, CA--(Marketwired - Feb 21, 2017) - Marina Biotech, Inc. ( : MRNA), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension and cancer, today announced the appointment of Seymour Fein, M.D., as Chief Medical Officer "I am thrilled to welcome Dr. Fein to the Marina Biotech team," stated Joseph W. Ramelli, CEO of Marina Biotech. "His strong background and expertise in gastroenterology and oncology, make him the perfect fit to oversee the clinical development of Marina Biotech's pipeline. The fact that he has successfully taken over 20 drugs through development to approval, is a strong endorsement of the potential for the company to successfully develop innovative therapies for horrible diseases such as familial adenomatous polyposis (FAP)." "I'm excited to join the Marina Biotech team and for the opportunity to help develop CEQ508 for the unmet medical need of FAP. This product is a first in class shRNA which utilizes a novel delivery technology enabling oral administration and direct targeting of the dysplastic tissue," stated Dr. Seymour Fein. Dr. Fein's professional activities have been focused on drug development research for over 35 years. He has been extensively involved in the successful development of numerous drugs, biologics and medical devices over this time leading to FDA approvals for over 20 drugs (NDAs, sNDAs, BLAs) and devices (PMAs). Dr. Fein began his career at Hoffmann-La Roche Ltd. as a senior research physician and was responsible for a clinical development program that led to U.S. Food and Drug Administration (FDA) approval of recombinant interferon-alpha for cancer treatment. Dr. Fein was also the medical director of Bayer Healthcare Pharmaceuticals (U.S.) where he was responsible for therapeutic areas including gastroenterology, oncology, and cardiology. He later served as medical director for Rorer Group (now part of Sanofi) and Ohmeda (now part of Baxter). Dr. Fein founded and has been managing partner of a clinical and regulatory consulting organization and has worked closely with the Division of Gastroenterology and Inborn Errors Products at the FDA. He has participated in the development of and FDA approval of numerous drug products in many therapeutic areas. Dr. Fein has successfully overseen entrepreneurial drug development leading to the FDA approval of two orphan drug products in the field of gastroenterology. Dr. Fein received his B.A. degree from the University of Pennsylvania and his M.D. degree with honors from New York Medical College. He completed a three-year residency in internal medicine at Dartmouth and a three-year fellowship in medical oncology and hematology at Harvard Medical School, where he served as an instructor of medicine during his final fellowship year. Dr. Fein is board-certified in both oncology and internal medicine. About Marina Biotech, Inc. Marina Biotech is a biotechnology company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer. Our pipeline includes combination therapies of oligonucleotide-based therapeutics and small molecules. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome). By its merger with IthenaPharma, Marina Biotech recently acquired IT-102/IT-103 -- next generation celecoxib -- which will be developed together with CEQ508 as a therapeutic enhancer for therapies against FAP and CRC. IT-102/IT-103 are also being developed for the treatment of combined arthritis/ hypertension and treatment of pain requiring high dose of celecoxib. Additional information about Marina Biotech is available at http://www.marinabio.com. Marina Biotech Forward-Looking Statements Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to successfully integrate its business operations with those of IthenaPharma; (ii) the ability of Marina Biotech to obtain funding to support its clinical development; (iii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iv) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (v) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (vi) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech's most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.
News Article | February 15, 2017
March is colorectal cancer awareness month and, if you’re over 50 or if you’re younger than 50 but have a family history, it is a very good time to undergo a screening colonoscopy. Colorectal cancer is the second most common cancer in the United States and is also one of the most preventable. Most colorectal cancers develop from noncancerous polyps and removing these polyps can markedly reduce your risk of getting the disease. Ohio Gastroenterology & Liver Institute (http://www.ohiogi.com) cares about the community and strongly believes in the importance of colorectal screening. That is why OGI are donating 100 referrals to receive the HyGIeaCare® Prep which will allow patients to achieve excellent preparation of the colon by a method which is much more easily tolerated than traditional oral bowel preps. The HyGIeaCare® Center is located at 4746 Montgomery Rd. Suite 200 - Cincinnati, OH (call 513-569-1343 for scheduling) and features the HyGIeaCare® System which is approved by the U.S. Food and Drug Administration (FDA) and which effectively cleans the bowel using a gentle infusion of warm, gravity-flow filtered water. “At Ohio GI, we pride ourselves on personalized, professional, prompt, specialized care for each and every patient,” said Pradeep Bekal MD, a gastroenterologist from Ohio GI. “Screening for colorectal cancer saves lives and having an excellent preparation is key to effective colonoscopy. I urge the community to call and schedule their colonoscopy and benefit from our exclusive offering of HyGIeaCare® Prep.” The convenience of HyGIeaCare prep for colonoscopy At the HyGIeaCare® Center, the prep is performed in a clean and comfortable environment. Our trained technician leads the patient to a private room where he or she is seated on an ergonomic basin. The technician walks the patient through the procedure, which routinely takes less than one hour. A small, sterile, disposable nozzle is easily inserted about an inch into the rectum and a gentle stream of warm water flows into the bowel, loosening stool and causing the intestine to contract allowing for the comfortable, odorless and discreet evacuation of the colon. Water continues to gently flow until the technician determines the colon has been sufficiently cleansed. The HyGIeaCare Prep replaces traditional oral preps for colonoscopy and is performed immediately prior to the scheduled colonoscopy. It is safe, comfortable and preferred over oral preps. For more information about HyGIeaCare® please go to: http://www.hygieacare.com Ohio Gastroenterology and Liver Institute (“Ohio GI”) Ohio GI (http://www.ohiogi.com ) is the largest and most comprehensive private Gastroenterology practice servicing Greater Cincinnati, Fairfield and Northern Kentucky. Ohio GI combines unparalleled personalized expertise with prompt appointments in geographically convenient offices and related Endoscopy Centers. As the area’s Gastroenterology innovation leader Ohio GI introduces cutting edge therapies and medical technologies. Ohio GI offers consultative and procedural expertise by employing physicians who sub-specialize in important areas such as Inflammatory Bowel Disease (IBD), Pancreatic Diseases, Hepatology / Liver Diseases, Women’s Digestive Health and Esophageal / Swallowing Disorders as well as screening colonoscopy and preventative health management. Ohio GI monitors a variety of quality metrics (eg, cecal intubation rates, colonoscopy withdrawal times, adenoma detection rates) to ensure that its physicians exceed national benchmark standards. Ohio GI operates a major national Medical Research Center and has participated in many pivotal trials which have led to the approval of new treatments for Crohns Disease, Ulcerative Colitis, Irritable Bowel Syndrome, GERD, Hepatitis B, Hepatitis C, Duodenal Ulcers and Gastric Ulcers. The physicians of Ohio GI are also actively engaged in Greater Cincinnati’s local and regional medical community as well as with a variety of national Gastroenterology societies. About HyGIeaCare, Inc.(http://www.hygieacare.com) Chairman and CEO Gavriel (Gabi) Meron - the founder and former CEO of Given Imaging, the Company that successfully brought the PillCam to the world - partnered with Texas-based Lifestream Purification Systems to form HyGIeaCare, Inc. to bring the HyGIeaCare FDA-cleared Prep System and procedure exclusively to the GI world. The goal of HyGIeaCare is to provide unique services and solutions to gastroenterologists to deliver better GI outcomes for their patients and their practice through HyGIeaCare Centers to be established in the US and throughout the world.
News Article | February 17, 2017
Vooraanstaand expert Jørgen Jahnsen, hoogleraar Gastro-enterologie aan de Universiteit van Oslo, Noorwegen, gaf commentaar op de studie: “ Dit is de eerste RCT om het gebruik van een biosimilar bij inflammatoire darmaandoeningen te onderzoeken. Hoewel we al een schat aan geëxtrapoleerde en parktijkgegevens voor CT-P13 hebben, wilden gastro-enterologen al enige tijd de zekerheid van een RCT, en het is bemoedigend om dergelijke positieve data te zien van het RCT-onderzoek van Celltrion.” De werkelijke kostenbesparingen in verband met het gebruik van CT-P13 voor alle indicaties werden onderzocht in vijf Europese landen vanaf begin 2015 tot de eerste helft van 2016. Volgens de op ECCO gepresenteerde data bedroegen de totale kostenbesparingen waargenomen voor Duitsland, Italië, Spanje en het Verenigd Koninkrijk € 32,4 miljoen, en de bevindingen suggereren dat hierdoor nog eens 5428 patiënten per jaar toegang kunnen krijgen tot deze belangrijke biologische therapie. Er waren geen kostenbesparingen in Frankrijk, omdat de prijs van de biosimilar en het referentieproduct infliximab gelijk waren. Desondanks is het gebruik van CT-P13 in dit land echter geleidelijk toegenomen.4 Man Hoon Kim, President en CEO van Celltrion Healthcare, verklaarde: “ Bij Celltrion zijn we toegewijd aan het aanpakken van de behoeften van de klinische gemeenschap door middel van robuuste wetenschappelijke exploratie. Een pivotaal RCT-onderzoek naar de ziekte van Crohn is hiervan een belangrijk voorbeeld. De resultaten van dit cruciale onderzoek zijn in overeenstemming met onze andere RCT's en vele IBD-praktijkstudies die zijn uitgevoerd. Meer in het algemeen is het bevredigend om de veranderingen te zien die CT-P13 maakt in de voor financiële problemen staande gezondsheidszorgsystemen in Europa.” Inflammatoire darmziekten (IBD) zoals de ziekte van Crohn (CD) en colitis ulcerosa (UC) zijn chronische invaliderende gastrointestinale aandoeningen die van invloed zijn op het gehele leven van een patiënt.5 Ongeveer 2,5 - 3 miljoen mensen in Europa worden er door getroffen;6 CD treft ongeveer drie personen per 1.000 en UC ongeveer 5 personen per 1000.5 Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ De studie is een gerandomiseerde, dubbelblinde, parallelgroep, Fase Ⅲ studie om de werkzaamheid en veiligheid te onderzoeken van CT-P13 en referentie infliximab bij CD-patiënten. Van 220 patiënten gerandomiseerd in 58 studiecentra in 16 landen, maakten 214 patiënten vol tot week 6 voor de primaire analyse en 180 patiënten tot week 30. De studie werd in gelijke mate gefinancierd door Celltrion en Pfizer. CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Beschikbaar op www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [laatst bekeken januari 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.
News Article | February 22, 2017
An early-stage clinical trial has found that, compared to a placebo, a novel medication significantly reduces potentially life-threatening episodes of swelling of the airway as well as the hands, feet, and abdomen of patients affected by a rare genetic disorder. The findings were published in the New England Journal of Medicine. Although the small study was designed to test safety of the drug, the findings were so obviously promising that an expedited phase III clinical study has just started enrolling patients at the Icahn School of Medicine at Mount Sinai and other locations. The study's co-lead author, Paula Busse, MD, is an allergist-immunologist at Mount Sinai and an associate professor at the Icahn School of Medicine. The disorder, hereditary angioedema (HAE), causes recurrent and unpredictable attacks of swelling throughout the body. What triggers these attacks is not known. The multicenter, double-blind, placebo-controlled phase 1b study of 37 patients with type 1 or 2 HAE found that all participants that used a 300-mg dose of the drug, lanadelumab, were attack-free, as were 82 percent who took 400 mg. Only 27 percent of participants who used a placebo were incident-free. "Lanadelumab appears to stop attacks of HAE before they start, and this prophylactic approach may represent an exciting new advance for patients," says Dr. Busse, who treats dozens of patients with the disorder. "Given the uncertainty of when an attack may happen, some HAE patients don't want to travel," she says. "The disease can produce such swelling for three to five days that a face is disfigured, hands can't be used, it is difficult to walk, and the abdomen can become very painful. Having a drug that can provide an ongoing buffer against HAE will be wonderful." Current therapies for preventing HAE attacks work, but there are some drawbacks, Dr. Busse adds. A drug known as a C-1 inhibitor needs to be given intravenously every three or four days, and another approach, the use of pills called androgens (a modified testosterone), can produce unwanted hair growth in women, affect mood, cause weight gain, affect lipid levels and liver function, and inhibit growth in children. Lanadelumab, on the other hand, is a monoclonal antibody that is injected every two weeks and was found to be well tolerated by patients in this trial. HAE is an autosomal, dominantly inherited blood disorder caused by a deficiency or dysfunction of a regulatory gene known as the C1 inhibitor. The C1 inhibitor protein normally suppresses the production of another protein called bradykinin, which is the cause of swelling. Without a C1 inhibitor that functions properly, a person produces more bradykinin and consumes less of it. Bradykinin causes the swelling (angioedema) by making vessels dilate and leak fluid. The study included extensive blood analysis, which closely tracked how the drug successfully suppressed production of bradykinin. "If the phase III clinical study confirms the benefit we have seen, lanadelumab will make life much easier for HAE patients," says Dr. Busse. "Many patients who don't like and therefore don't use current treatments will likely opt for this new therapy, which will hopefully reduce morbidity and mortality, and improve the quality of life of patients with HAE." Dr. Busse worked with researchers from a number of universities nationally, and with a research team from Dyax, the developer of Lanadelumab and supporter of the trial. The Mount Sinai Health System is an integrated health system committed to providing distinguished care, conducting transformative research, and advancing biomedical education. Structured around seven hospital campuses and a single medical school, the Health System has an extensive ambulatory network and a range of inpatient and outpatient services--from community-based facilities to tertiary and quaternary care. The System includes approximately 7,100 primary and specialty care physicians; 12 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. Physicians are affiliated with the renowned Icahn School of Medicine at Mount Sinai, which is ranked among the highest in the nation in National Institutes of Health funding per investigator. The Mount Sinai Hospital is in the "Honor Roll" of best hospitals in America, ranked No. 15 nationally in the 2016-2017 "Best Hospitals" issue of U.S. News & World Report. The Mount Sinai Hospital is also ranked as one of the nation's top 20 hospitals in Geriatrics, Gastroenterology/GI Surgery, Cardiology/Heart Surgery, Diabetes/Endocrinology, Nephrology, Neurology/Neurosurgery, and Ear, Nose & Throat, and is in the top 50 in four other specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 10 nationally for Ophthalmology, while Mount Sinai Beth Israel, Mount Sinai St. Luke's, and Mount Sinai West are ranked regionally. Mount Sinai's Kravis Children's Hospital is ranked in seven out of ten pediatric specialties by U.S. News & World Report in "Best Children's Hospitals." For more information, visit http://www. , or find Mount Sinai on Facebook, Twitter and YouTube.
News Article | March 1, 2017
GALWAY, Ireland--(BUSINESS WIRE)--The American Gastroenterology Association (AGA) Institute Clinical Practice Updates Committee (CPUC) has issued a clinical practice update and expert review of the functional lumen imaging probe (FLIP®). The clinical practice update, published in the March issue of Clinical Gastroenterology and Hepatology, gives advice on five areas of best practice for the Food and Drug Administration (FDA) cleared measurement tool used to guide management of various upper gastrointestinal disorders. The FLIP® is indicated for use with an endoflip® System in a clinical setting to measure pressure and dimensions in the esophagus, pylorus and anal sphincters. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders. It is also used to guide therapy during bariatric procedures and specialized esophageal surgery. The clinical practice update describes the technique and reviews the potential indications in achalasia, EoE and GERD, making the following ‘Best Practice Advice Statements’: 1. Best Practice Advice Statement 1: Clinicians should not make a diagnosis or treatment decision based on function lumen imaging probe (FLIP®) assessment alone; 2. Best Practice Advice Statement 2: FLIP® assessment is a complementary tool to assess esophagogastric junction (EGJ) opening dynamics and the stiffness of the esophageal wall; 3. Best Practice Advice Statement 3: Utilization should follow distinct protocols and analysis paradigms based on the disease state of interest; 4. Best Practice Advice Statement 4: Clinicians should not utilize FLIP in routine diagnostic assessments of gastroesophageal reflux disease (GERD); 5. Best Practice Advice Statement 5: FLIP® should not be used to diagnose eosinophilic esophagitis (EoE) but may have a role in severity assessment and therapeutic monitoring. The best practice update notes: “The evolution of esophageal function testing has moved rapidly over the last 10 years along the continuum of manometric technique and bolus transit assessment. FLIP® offers an innovative method that enhances the assessment of esophageal function in various diseases including the management of achalasia. Emerging evidence also supports the clinical relevance of FLIP in assessing disease severity and measuring outcomes in EoE. We recommend that further evaluation is required in the application of FLIP® to GERD interventions targeting the EGJ and other foregut disorders”. The AGA Institute Clinical Practice Updates Committee is charged with providing authoritative and balanced articles for Gastroenterology and Clinical Gastroenterology and Hepatology. “We acknowledge and welcome the role the AGA Institute is playing in updating the Gastroenterology profession on new technologies by providing objective clinical assessment in these clinical practice updates. We agree that FLIP® technology, which is at the core of Crospon’s endoflip® imaging system, is a complementary tool to assist clinicians in diagnosis, particularly in conjunction with endoscopy”, said John O’Dea, CEO and Founder of Crospon. “We would concur that there is more work needed to progress the use of FLIP® in GERD diagnostics, however, but would note that intra-operative use of the technology in GERD surgery is more advanced. While not a diagnostic tool for clinicians in cases of suspected EoE, endoflip® has a role to play in measuring the response of the esophagus to treatment, particularly where there is a narrowing due to fibro-stenosis and in predicting the risk of food impaction ”. The clinical practice update also concluded that more work is needed which focuses on optimizing data analytics, standardizing protocols, and defining outcome metrics. John O’Dea agreed, adding: “We think that is a fair comment presently but developments on further analysis and reporting modules are in progress. The introduction of real-time FLIP® Topography and analytics of maximal esophageal diameter in future software updates along with additions to our endoflip® product line later this year will address a number of these issues”. Crospon is an endoscopic diagnostics company that is changing the face of esophageal function testing with its endoflip® and esoflip® technologies. The minimally invasive medical devices transform the patient experience when it comes to swallow testing and deliver a whole new diagnostic tool set into the hands of gastroenterology professionals. Established in 2006 by chairman and chief executive John O’Dea and with offices in the US and Ireland, Crospon’s experienced team designs and manufactures medical devices that allow clinicians to assess the real-time effects of their interventions during endoscopic and laparoscopic procedures.
News Article | February 18, 2017
1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.
News Article | February 15, 2017
While diet, exercise and behavior modification are essential components of obesity management, a successful long-term weight loss strategy should also include avoiding or minimizing medication-related weight gain, according to a new report from Weill Cornell Medicine. In the paper, published Feb. 10 in Gastroenterology, investigators from the Comprehensive Weight Control Center at Weill Cornell Medicine underscore the necessity for physicians to evaluate the potential side effects and interactions of medications they prescribe for patients with obesity, and to familiarize themselves with alternatives that may limit weight gain or may even assist with weight loss. "Physicians know that some medications can increase weight, but they don't always know what alternatives are out there," said lead author Dr. Leon Igel, an assistant professor of clinical medicine in the Division of Endocrinology, Diabetes and Metabolism at Weill Cornell Medicine. "We want physicians who treat patients with obesity to feel more comfortable prescribing these alternatives. Our paper looks at how to practically manage patients with obesity by prescribing the optimal medications for them." Numerous factors contribute to obesity and the body's inability to shed excess weight, including commonly used medications such as steroids or contraceptives. Additional impediments to weight loss may include medications such as insulin, metoprolol and paroxetine, which are vital for treating, respectively, diabetes, hypertension and depression - chronic conditions that are common among people with obesity. However, a patient's weight loss desire does not typically guide a physician's prescribing practices. "Each practitioner has a goal in mind," Dr. Igel said. "A cardiologist wants to lower blood pressure. A psychiatrist wants to make sure that mood is well regulated. They're not necessarily focusing on which medications will affect weight, but rather what will achieve their treatment goal." It is essential, therefore, that internists and other physicians be aware of what medications their patients are taking and how they are likely to interact; recognizing when they can prescribe one medication as a substitute for another, or pair a medication that causes weight gain with one that minimizes its effect. "Not everyone can be taken off insulin," Dr. Igel said. But some patients might be able to couple insulin with other agents that promote weight loss to neutralize insulin's effect on weight. Obesity, which is defined as a body mass index of greater than or equal to 30, affects approximately one-third of all Americans. Taking multiple medications to manage chronic conditions is common among this population. Less common is the use of dedicated weight loss medication, which many insurers do not cover, and few physicians are trained to prescribe. Still, physicians should know which patients would be optimal candidates for each weight loss medication, and when certain weight loss medications should be avoided, Dr. Igel said. For example, patients with uncontrolled hypertension, coronary disease, hyperthyroidism, or glaucoma should not take phentermine, an appetite suppressant that is also a stimulant. "We wanted to provide extra guidance, so that practitioners are using the right types of medications for the right types of patients," Dr. Igel said.
News Article | February 27, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Infusion Pump Market by Product (Volumetric, Syringe, Enteral, Insulin, Implantable, PCA, Accessories), Application (Oncology, Diabetes, Gastroenterology, Analgesia, Pediatrics, Hematology) & End User (Hospital, Home care) - Global Forecast to 2021" report to their offering. The global infusion pumps market is estimated to grow at a CAGR of 6.0% from 2016 to 2021, to reach USD 10.84 billion by 2021 from USD 8.12 billion in 2016. Increasing prevalence of chronic diseases along with increasing geriatric population, increasing adoption of portable infusion pumps to reduce hospital expenditure, steady increase in surgical procedural volumes, and rising applications of infusion pumps in pain management are some of the key factors driving the growth of this market. However, patient safety risks and medication errors associated with infusion pumps leading to product recalls and stringent regulations for new products may restrict the growth of this market during the forecast period. On the basis of product type, the infusion pumps market is segmented into devices and accessories. The Accessories segment is further segmented into dedicated and non-dedicated disposables. The dedicated disposables segment accounted for the largest share of the infusion pump accessories market in 2015. Devices segment is further subsegmented into volumetric infusion pumps, syringe infusion pumps, insulin infusion pumps, enteral infusion pumps, ambulatory infusion pumps, patient-controlled analgesia infusion pumps, and implantable infusion pumps. In 2015, the volumetric infusion pumps segment dominated the infusion pump devices market. The large share of this segment can be attributed to the increasing demand for volumetric infusion pumps in hospitals, long-term acute care centers, clinics, and ambulatory surgery centers. For more information about this report visit http://www.researchandmarkets.com/research/8ch6tl/infusion_pump
News Article | March 1, 2017
NEW YORK--(BUSINESS WIRE)--Please replace the release, dated March 1, 2017, with the following corrected version due to multiple revisions in the Financial Results bullets and financial tables. SYNERGY PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2016 FINANCIAL RESULTS AND BUSINESS UPDATE Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today reported its financial results and business update for the full year and the three months ended December 31, 2016. “The approval of TRULANCE™ (plecanatide) in the United States for the treatment of adults with chronic idiopathic constipation was a tremendous event not just for Synergy, but also for the millions of patients with CIC who have been in need of a new therapeutic option,” said Gary S. Jacob, PhD, Chairman and Chief Executive Officer of Synergy Pharmaceuticals Inc. “I am pleased with the progress our team has made implementing a strong and compelling commercial plan, a robust high quality supply chain, and ensuring that the Synergy organization, healthcare providers and payers, are well prepared for the launch of TRULANCE this month. In addition, we are continuing our efforts to bring TRULANCE to patients with irritable bowel syndrome with constipation, as we remain on-track to file a supplemental new drug application (sNDA) this month.” “Together with the approval of TRULANCE, the fourth quarter of 2016 and beginning of 2017 were marked by several key accomplishments, including positive top-line results in two Phase 3 trials of TRULANCE in IBS-C which will support the sNDA filing and the recent publication of our Phase 3 CIC data in the American Journal of Gastroenterology. We’ve also strengthened our balance sheet and enhanced our strategic options as we completed a $125 million financing, continued to reduce our convertible debt and successfully eliminated restrictive covenants associated with that debt. These achievements put Synergy in an excellent position for future growth as we begin to commercialize our first product, TRULANCE.” We are focused on three key strategic imperatives to achieve our objective of ensuring that TRULANCE is ready for launch this quarter: TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC). Please click here for Full Prescribing Information. CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual’s quality of life, including increasing stress levels and anxiety. Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with 2 or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D), or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time. It is estimated that the prevalence of IBS-C in the U.S. adult population is approximately 4 to 5 percent, although this number may vary as patients often fluctuate between the three subtypes of IBS. TRULANCE™ (plecanatide) is a once-daily tablet approved for adults with CIC and is being evaluated for IBS-C. With the exception of a single amino acid, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin is thought to act in a pH-sensitive manner, targeting GC-C receptors primarily in the small intestine coinciding with areas of fluid secretion. Synergy is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. The company has pioneered discovery, research and development efforts on analogs of uroguanylin, a naturally occurring and endogenous human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary uroguanylin analog platform includes one commercial product TRULANCE (plecanatide) and a second lead product candidate - dolcanatide. For more information, please visit www.synergypharma.com. Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Annual Report on Form 10-K for the year ended December 31, 2016 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.