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NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) announced today its equity investment and plans for a research collaboration with GRAIL Inc., a life sciences company whose mission is to detect cancer early when it potentially can be cured. By combining the power of high intensity cancer DNA sequencing, leading edge computer science and large clinical studies into a diagnostic platform, GRAIL aims to develop highly sensitive blood tests that detect cancer in its early stages to enable earlier intervention with targeted therapies. As an investor, Bristol-Myers Squibb will gain early access to GRAIL’s comprehensive clinical trial databases that may serve as a rich resource for understanding tumor genomics. Additionally, Bristol-Myers Squibb and GRAIL have agreed to principal terms of a research collaboration that would enable Bristol-Myers Squibb to examine its clinical data using GRAIL’s analytic tools to inform research and development decisions, guide strategies to advance point of care companion diagnostics and potentially improve selection, care and management of patients through more targeted treatments. “ A key enabler of our Immuno-Oncology strategy is to leverage precision medicine to speed the selection of the most effective combinations of therapies for patients,” said Francis Cuss, MB BChir, FRCP, chief scientific officer, Bristol-Myers Squibb. “ GRAIL’s future innovation potential is significant. Liquid biopsies hold the potential to support much earlier intervention and better define individual patient characteristics that may enhance treatment decisions.” Bristol-Myers Squibb has a diverse early portfolio of Immuno-Oncology mechanisms it’s evaluating across a broad range of tumors and modalities, with 10 investigational I-O molecules in the clinic and ongoing registrational trials in 14 tumor types. Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook. This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical studies discussed in this release will be successfully developed or approved for any of the uses described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


CAMBRIDGE, Mass., May 17, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported interim data from the Phase 1 study of DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. Data from the study was published online as an abstract in advance of a poster presentation being held at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6, 2017 in Chicago, Illinois.   “These data combining DKN-01 with gemcitabine and cisplatin are highly encouraging and provide a strong rationale for advanced clinical development. Biliary tract cancer is an aggressive disease with a poor prognosis and for which there are limited treatment options.  First-line chemotherapy studies have reported response rates of 20% to 25%, progression-free survival of 5.6 to eight months, and overall survival of 11 to 12 months,” commented Jennifer Eads, MD, of the University Hospitals Siedman Cancer Center at Case Western Reserve University and an investigator on the study. Data from the study showed that DKN-01 in combination with gemcitabine and cisplatin was well tolerated with no new emerging safety trends.  At the selected 300 mg DKN-01 dose level, seven of 22 patients (31.8%) experienced a partial response and 21 patients experienced a partial response or stable disease, representing a disease control rate of 95.5%. The preliminary median progression-free survival was 9.4 months, and the median overall survival was not yet reached. The median number of cycles of DKN-01 was eight (range of one to 17), and the median duration on study was 206 days.  Eight patients were still on therapy as of the time of data cut-off. “This study suggests that DKN-01 shows activity in combination with gemcitabine and cisplatin. Results so far look promising, and further evaluation of its additional benefit over standard of care chemotherapy in patients with biliary tract cancer is warranted,” commented Juan Valle MB ChB MSc FRCP, Professor of Medical Oncology in the University of Manchester (Institute of Cancer Studies) and primary investigator of the landmark Phase 3 ABC-02 study evaluating gemcitabine and cisplatin for the treatment of advanced biliary tract cancers. “We are encouraged by the impressive durable responses in patients with advanced biliary tract cancer,” said Christopher K. Mirabelli, Ph.D., Chief Executive Officer of Leap Therapeutics. “We have recently expanded the study to enroll an additional 20 patients to further characterize the patients that respond to DKN-01 combination therapy. Based on the safety and efficacy profile seen to date, we are aggressively moving DKN-01 forward in biliary tract cancer, genetically-defined patient populations in gastric, liver, and uterine cancers, and soon in combination with checkpoint inhibitors.” About the Study The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received one of two dose levels (150 mg or 300 mg) of DKN-01 in combination with gemcitabine and cisplatin during Part A, with 20 additional patients treated at 300 mg dose level of DKN-01 in the Part B expansion cohort. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. Leap Poster Presentation Details Abstract Number: 4075 Title:  “A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC).” Session Title: Poster Session: Gastrointestinal (Noncolorectal) Cancer Date: June 3, 2017 Time: 8:00AM-11:30AM Central Time About Leap Therapeutics Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer, alone and in combination with paclitaxel, and in patients with biliary tract cancer, in combination with gemcitabine and cisplatin. An investigator-initiated study of DKN-01 will be conducted in hepatocellular carcinoma patients, in combination with sorafenib.  DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response that is in two monotherapy studies.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the "SEC"), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.


CAMBRIDGE, Mass., May 17, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported interim data from the Phase 1 study of DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. Data from the study was published online as an abstract in advance of a poster presentation being held at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6, 2017 in Chicago, Illinois.   “These data combining DKN-01 with gemcitabine and cisplatin are highly encouraging and provide a strong rationale for advanced clinical development. Biliary tract cancer is an aggressive disease with a poor prognosis and for which there are limited treatment options.  First-line chemotherapy studies have reported response rates of 20% to 25%, progression-free survival of 5.6 to eight months, and overall survival of 11 to 12 months,” commented Jennifer Eads, MD, of the University Hospitals Siedman Cancer Center at Case Western Reserve University and an investigator on the study. Data from the study showed that DKN-01 in combination with gemcitabine and cisplatin was well tolerated with no new emerging safety trends.  At the selected 300 mg DKN-01 dose level, seven of 22 patients (31.8%) experienced a partial response and 21 patients experienced a partial response or stable disease, representing a disease control rate of 95.5%. The preliminary median progression-free survival was 9.4 months, and the median overall survival was not yet reached. The median number of cycles of DKN-01 was eight (range of one to 17), and the median duration on study was 206 days.  Eight patients were still on therapy as of the time of data cut-off. “This study suggests that DKN-01 shows activity in combination with gemcitabine and cisplatin. Results so far look promising, and further evaluation of its additional benefit over standard of care chemotherapy in patients with biliary tract cancer is warranted,” commented Juan Valle MB ChB MSc FRCP, Professor of Medical Oncology in the University of Manchester (Institute of Cancer Studies) and primary investigator of the landmark Phase 3 ABC-02 study evaluating gemcitabine and cisplatin for the treatment of advanced biliary tract cancers. “We are encouraged by the impressive durable responses in patients with advanced biliary tract cancer,” said Christopher K. Mirabelli, Ph.D., Chief Executive Officer of Leap Therapeutics. “We have recently expanded the study to enroll an additional 20 patients to further characterize the patients that respond to DKN-01 combination therapy. Based on the safety and efficacy profile seen to date, we are aggressively moving DKN-01 forward in biliary tract cancer, genetically-defined patient populations in gastric, liver, and uterine cancers, and soon in combination with checkpoint inhibitors.” About the Study The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received one of two dose levels (150 mg or 300 mg) of DKN-01 in combination with gemcitabine and cisplatin during Part A, with 20 additional patients treated at 300 mg dose level of DKN-01 in the Part B expansion cohort. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. Leap Poster Presentation Details Abstract Number: 4075 Title:  “A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients (pts) for first-line therapy with advanced biliary tract cancer (BTC).” Session Title: Poster Session: Gastrointestinal (Noncolorectal) Cancer Date: June 3, 2017 Time: 8:00AM-11:30AM Central Time About Leap Therapeutics Leap Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is in clinical trials in patients with gastroesophageal cancer, alone and in combination with paclitaxel, and in patients with biliary tract cancer, in combination with gemcitabine and cisplatin. An investigator-initiated study of DKN-01 will be conducted in hepatocellular carcinoma patients, in combination with sorafenib.  DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response that is in two monotherapy studies.  For more information about Leap Therapeutics, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via http://www.investors.leaptx.com/. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap’s expectations with respect to the development and advancement of DKN-01, TRX518, and other programs, including the initiation, timing and design of future studies, enrollment in future studies, business development, and other future expectations, plans and prospects. Leap has attempted to identify forward looking statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics’ periodic filings with the Securities and Exchange Commission (the "SEC"), including Leap Therapeutics’ Form 10-K that Leap filed with the SEC on March 31, 2017. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.


News Article | April 17, 2017
Site: www.prweb.com

The Osteoarthritis Research Society International (OARSI) will host the 2017 World Congress on Osteoarthritis, April 27 – 30 at Caesar’s Palace in Las Vegas, Nevada. The annual OARSI Congress is a global forum for those involved in OA research and treatment from academia and industry. The meeting features international speakers presenting the latest information on a wide range of topics related to joint damage and OA. More than 1,100 of the world's leading scientists, clinicians, clinical investigators, rheumatologists, orthopedists, radiologists and others interested in osteoarthritis research are expected to attend this broad-based global forum presented annually by OARSI. “The World Congress brings together professionals across all disciplines to learn about new technologies and research in the OA field,” said Dr. Tonia Vincent, Congress Program Chair and OARSI Board Member. “The program committee has worked tirelessly to develop a program that will allow attendees the opportunity to learn and network with some of the best and most informed professionals in the industry.” This 2017 World Congress program features plenary sessions, concurrent sessions, breakfast workshops and more oral presentations of abstracts than any Congress before it. Attendees may receive Continuing Medical Education credits by registering and attending sessions. Back by popular demand, there will be a debate held on Saturday, April 29 titled, Is Exercise Good or Bad for OA?! Dr. Stephen Messier is well-known for his work on the effects of exercise and weight loss on gait, strength, function, and pain in knee OA and will highlight the benefits of exercise in patients with OA. Dr. Nigel Arden, MBBS, FRCP, MSc, is an International Leader in epidemiology, predictive modelling and trial design and will focus on the negative effects of exercise for those with OA. o    Lifetime Achievement Award Recipient: Stefan Lohmander o    Basic Science Award Recipient: Francisco Blanco, "Osteoarthritis, From the Chondrocyte to the Mitochondria" o    Clinical Science Award Recipient: Frances Berenbaum,"Inflammation in Osteoarthritis: Why Does OA Occur in Non-weight Bearing Joints?" o    Lindsay Hall BSc, PhD, All You Need to Know About the Microbiome! - Discover the critical role your gut and its resident microbes play in host well-being. Dr Lindsay Hall from the Institute of Food Research will talk through the role of the microbiota, including detection methodologies, bacterial biology and how the microbiota controls different physiological functions such as immune system development. New features at this year’s Congress include: o    The goal of this new course is to equip investigators and industry sponsors to understand the complexities of running patient-oriented randomized clinical trials in osteoarthritis. Programming for Young Investigators: OARSI offers an interactive forum designed for young investigators to meet leaders in OA research to seek career and research advice. Various programs throughout the Congress link young investigators with someone working within their field of interest. For more information or to obtain a press pass for any of the offered sessions or abstracts visit http://2017.oarsi.org/. Opportunities to sponsor the OARSI 2017 Congress are also available. About OARSI: OARSI is the premier international organization for scientists and health care professional focused on the prevention and treatment of osteoarthritis through the promotion and presentation of research, education and the worldwide dissemination of new knowledge. For more information on the 2017 World Congress on Osteoarthritis and a complete schedule of events visit http://2017.oarsi.org/.


LUND, Sweden, Feb. 22, 2017 /PRNewswire/ -- NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF), the mitochondrial medicine company, today announced two new research agreements and the appointment of Professor Philippe Gallay, PhD, and Professor Massimo Pinzani, MD, PhD, FRCP, as scientific advisors. The aim of the agreements is to further explore NeuroVive's new drug compounds in development for the treatment of NASH and hepatocellular carcinoma (HCC). In the new collaboration with Philippe Gallay, the research teams will explore the mechanisms of action of the potent anti-cancer effects of NeuroVive's novel sanglifehrin-based compounds. These studies will be an important part in NeuroVive's HCC lead candidate selection process. "I am enthusiastic about continuing the fruitful collaboration with the NeuroVive research team. NeuroVive's potent drug compounds have unique and promising features that I am really excited in continuing to explore" said Prof. Philippe Gallay. In the collaboration with Massimo Pinzani, the research groups at Engitix Ltd and NeuroVive will assess the anti-fibrotic properties of NV556 by using Engitix' human liver 3D models. The models offer an important opportunity to evaluate and validate effects in appropriate pathophysiological conditions. "Fibrosis is a critical part of the progression of several liver diseases including NASH, and I look forward to further study the anti-fibrotic effects of NeuroVive's new drug compounds and how they may contribute to fill the unmet medical need in this area", said Prof. Massimo Pinzani. "I am very pleased that Philippe Gallay and Massimo Pinzani have joined our efforts in advancing the research and development of our NASH and HCC treatment opportunities" said Magnus Hansson, Chief Medical Officer at NeuroVive. "Their scientific guidance as experts in the field of liver disease mechanisms and clinical management will be most valuable in the continued development of our project pipeline, as well as in the ultimate positioning of our candidate drugs in the future treatment landscape." Philippe Gallay is Professor of Immunology at the Department of Immunology and Microbiology at the well esteemed Scripps Research Institute in California, US. Phillipe Gallay and NeuroVive has previously worked together with the company's cyclophilin inhibitor platform, a research effort that focused on the most potent cyclophilin inhibitor so far developed, NV556. Massimo Pinzani is Professor of Medicine, clinical hepatologist and Director of the University College London (UCL) Institute for Liver and Digestive Health, UK. He also holds the prestigious chair of the Sheila Sherlock Liver Centre at the Royal Free Hospital in London and he is the Chairman of Engitix Ltd. Engitix Ltd is a spin-out from the UCL Institute for Liver and Digestive Health, based at the Royal Free Hospital, London. Engitix is using its proprietary human organ decellularization technology to develop tissue engineered products for application in regenerative medicine and drug target research. Engitix' core expertise is human whole-liver and tissue-specific and disease specific ECM (extra cellular matrix) scaffolds for treatment and research of liver disease. Liver cancer includes two major types: hepatocellular carcinoma (HCC) and intrahepatic bile duct cancer. HCC is the sixth most-common type of cancer and the third most-common cause of death worldwide. HCC patients have a high medical need for new and effective treatment alternatives. NeuroVive's NVP024 project is focused on the company's new generation of sanglifehrin-based compounds which have shown potent inhibitory effects on HCC cells and anti-cancer activity in an experimental model of HCC. About NASH and NeuroVive's projects NV556 and NVP022 Fatty liver, fibrosis and inflammation are hallmarks of NASH, a condition that can lead to cirrhosis of the liver or liver cancer. There is a strong link between NASH and other metabolic disorders, such as diabetes and obesity. About 3-5% of all Americans (about 15 million people) suffer from NASH and there are currently no registered treatments. NV556 is a potent cyclophilin inhibitor in NeuroVive's Sangamide class of compounds. NV556 has shown an inhibitory effect on fibrosis development in an experimental model of NASH. NVP022 is a novel class of compounds that has a completely different mode of action than NV556 that may complement NV556 in the treatment of NASH. NVP022 is targeting mitochondrial metabolic pathways in NASH. NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine. The company is committed to the discovery and development of medicines that preserve mitochondrial integrity and function in areas of unmet medical need. The company's strategy is to take drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive enhances the value of its projects in an organization that includes strong international partnerships and a network of mitochondrial research institutions, as well as expertise with capacities within drug development and production. NeuroVive has a project in early clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®). NeuroSTAT has orphan drug designation in Europe and in the US. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF). For investor relations and media questions, please contact: Cecilia Hofvander NeuroVive Tel: +46 (0)46-275-62-21 or ir@neurovive.com Charles Athle Nelson NeuroVive US representative Tel +1 212-961-6277 or ir.usa@neurovive.com This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 10:30 a.m. CET on February 22, 2017. This information was brought to you by Cision http://news.cision.com http://news.cision.com/neurovive-pharmaceutical/r/neurovive-appoints-recognized-scientific-advisors-and-enters-research-agreements-in-nash-and-hepatoc,c2195673 The following files are available for download:


LUND, Sweden, Feb 22, 2017 /PRNewswire/ -- NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP, OTCQX: NEVPF), the mitochondrial medicine company, today announced two new research agreements and the appointment of Professor Philippe Gallay, PhD, and Professor Massimo Pinzani, MD, PhD, FRCP, as scientific advisors. The aim of the agreements is to further explore NeuroVive's new drug compounds in development for the treatment of NASH and hepatocellular carcinoma (HCC). In the new collaboration with Philippe Gallay, the research teams will explore the mechanisms of action of the potent anti-cancer effects of NeuroVive's novel sanglifehrin-based compounds. These studies will be an important part in NeuroVive's HCC lead candidate selection process. "I am enthusiastic about continuing the fruitful collaboration with the NeuroVive research team. NeuroVive's potent drug compounds have unique and promising features that I am really excited in continuing to explore" said Prof. Philippe Gallay. In the collaboration with Massimo Pinzani, the research groups at Engitix Ltd and NeuroVive will assess the anti-fibrotic properties of NV556 by using Engitix' human liver 3D models. The models offer an important opportunity to evaluate and validate effects in appropriate pathophysiological conditions. "Fibrosis is a critical part of the progression of several liver diseases including NASH, and I look forward to further study the anti-fibrotic effects of NeuroVive's new drug compounds and how they may contribute to fill the unmet medical need in this area", said Prof. Massimo Pinzani. "I am very pleased that Philippe Gallay and Massimo Pinzani have joined our efforts in advancing the research and development of our NASH and HCC treatment opportunities" said Magnus Hansson, Chief Medical Officer at NeuroVive. "Their scientific guidance as experts in the field of liver disease mechanisms and clinical management will be most valuable in the continued development of our project pipeline, as well as in the ultimate positioning of our candidate drugs in the future treatment landscape." Philippe Gallay is Professor of Immunology at the Department of Immunology and Microbiology at the well esteemed Scripps Research Institute in California, US. Phillipe Gallay and NeuroVive has previously worked together with the company's cyclophilin inhibitor platform, a research effort that focused on the most potent cyclophilin inhibitor so far developed, NV556. Massimo Pinzani is Professor of Medicine, clinical hepatologist and Director of the University College London (UCL) Institute for Liver and Digestive Health, UK. He also holds the prestigious chair of the Sheila Sherlock Liver Centre at the Royal Free Hospital in London and he is the Chairman of Engitix Ltd. Engitix Ltd is a spin-out from the UCL Institute for Liver and Digestive Health, based at the Royal Free Hospital, London. Engitix is using its proprietary human organ decellularization technology to develop tissue engineered products for application in regenerative medicine and drug target research. Engitix' core expertise is human whole-liver and tissue-specific and disease specific ECM (extra cellular matrix) scaffolds for treatment and research of liver disease. Liver cancer includes two major types: hepatocellular carcinoma (HCC) and intrahepatic bile duct cancer. HCC is the sixth most-common type of cancer and the third most-common cause of death worldwide. HCC patients have a high medical need for new and effective treatment alternatives. NeuroVive's NVP024 project is focused on the company's new generation of sanglifehrin-based compounds which have shown potent inhibitory effects on HCC cells and anti-cancer activity in an experimental model of HCC. About NASH and NeuroVive's projects NV556 and NVP022 Fatty liver, fibrosis and inflammation are hallmarks of NASH, a condition that can lead to cirrhosis of the liver or liver cancer. There is a strong link between NASH and other metabolic disorders, such as diabetes and obesity. About 3-5% of all Americans (about 15 million people) suffer from NASH and there are currently no registered treatments. NV556 is a potent cyclophilin inhibitor in NeuroVive's Sangamide class of compounds. NV556 has shown an inhibitory effect on fibrosis development in an experimental model of NASH. NVP022 is a novel class of compounds that has a completely different mode of action than NV556 that may complement NV556 in the treatment of NASH. NVP022 is targeting mitochondrial metabolic pathways in NASH. NeuroVive Pharmaceutical AB is a leader in mitochondrial medicine. The company is committed to the discovery and development of medicines that preserve mitochondrial integrity and function in areas of unmet medical need. The company's strategy is to take drugs for rare diseases through clinical development and into the market. The strategy for projects within larger indications outside the core focus area is out-licensing in the preclinical phase. NeuroVive enhances the value of its projects in an organization that includes strong international partnerships and a network of mitochondrial research institutions, as well as expertise with capacities within drug development and production. NeuroVive has a project in early clinical phase II development for the prevention of moderate to severe traumatic brain injury (NeuroSTAT®). NeuroSTAT has orphan drug designation in Europe and in the US. The R&D portfolio consists of several late stage research programs in areas ranging from genetic mitochondrial disorders to cancer and metabolic diseases such as NASH. NeuroVive is listed on Nasdaq Stockholm, Sweden (ticker: NVP). The share is also traded on the OTCQX Best Market in the US (OTC: NEVPF). For investor relations and media questions, please contact: Cecilia Hofvander NeuroVive Tel: +46 (0)46-275-62-21 or ir@neurovive.com Charles Athle Nelson NeuroVive US representative Tel +1 212-961-6277 or ir.usa@neurovive.com This information is information that NeuroVive Pharmaceutical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 10:30 a.m. CET on February 22, 2017. This information was brought to you by Cision http://news.cision.com http://news.cision.com/neurovive-pharmaceutical/r/neurovive-appoints-recognized-scientific-advisors-and-enters-research-agreements-in-nash-and-hepatoc,c2195673 The following files are available for download:


News Article | February 17, 2017
Site: www.eurekalert.org

BOSTON - A new study led by researchers at Beth Israel Deaconess Medical Center (BIDMC) has found that lower levels of vitamin D in the blood increase the risk of clinical relapse in patients with Ulcerative Colitis (UC), an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the colon. The study was published in the February issue of the journal Clinical Gastroenterology and Hepatology. Lower vitamin D levels have been associated with active disease in patients with UC, but it has been unknown whether they increase disease relapses. "Prior studies in patients with Crohn's disease and Ulcerative Colitis had linked low vitamin D levels to disease flare-ups," said senior author Alan Moss, MD, a gastroenterologist at the Digestive Disease Center at BIDMC and Associate Professor of Medicine at Harvard Medical School. "However, it has been unclear if the flare-up was lowering vitamin D levels, or if low vitamin D levels were causing the flare-up. We thought that if we looked at vitamin D levels when the disease was inactive and then followed patients moving forward, the impact of baseline vitamin D levels on future events may be clearer." Moss and colleagues collected vitamin D serum levels through a physician-blinded prospective study of 70 patients with UC in clinical remission who were followed up after a surveillance colonoscopy at BIDMC. The study measured vitamin D levels in blood samples and levels of inflammation through blood tests and biopsies. The researchers then followed the patients for 12 months and compared the data from participating patients who remained well and the others who experienced relapses. The investigators found the mean baseline vitamin D level to be lower in patients who later relapsed than those who did not. "Patients who had higher vitamin D levels when their disease was in remission were less likely to experience a relapse in the future," said John Gubatan, MD, a physician at BIDMC and first author of the study. "This suggests that higher vitamin D levels may play some role in preventing the UC relapse." The threshold level of blood vitamin D that was protective was greater than 35ng/ml, which is within the range recommended by the National Institutes of Health for a healthy individual. Ongoing work by Gubatan and Moss is now examining the link between vitamin D and a protein called cathelicidin in the cells lining the colon. The link may have beneficial effects on microbial composition, an important component of a healthy colon. Building on this research, investigators are trying to unravel how vitamin D may protect cells in the colon and the microbial composition of the bacteria, fungi, protozoa and viruses that live on and inside the human body, Moss noted. In addition to Moss and Gubatan, the study was performed at BIDMC by authors Shuji Mitsuhashi, Talia Zenlea, MD, Laura Rosenberg, MD, and Simon Robson, MB, ChB, FRCP, PhD. This work was supported by grants from the National Institutes of Health (K23DK084338) and a Rabb Research Award (ACM). Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www. .


SAN CARLOS, Calif.--(BUSINESS WIRE)--In advance of the first-ever National Heart Valve Disease Awareness Day, the Lipoprotein(a) Foundation is highlighting a number of studies that demonstrate the impact of elevated Lp(a) and its significance as an independent, genetic risk factor for early cardiovascular disease. Recently published research has shown that elevated Lp(a) is the strongest independent genetic risk factor for heart valve disease and individuals with high Lp(a) may also be susceptible to earlier and more aggressive valve disease. The Lipoprotein(a) Foundation has partnered with the Alliance for Aging Research to promote National Heart Valve Disease Awareness Day on February 22, during National Heart Month. The Lipoprotein(a) Foundation recently issued an Infographic to raise awareness about aortic valve disease, including aortic stenosis, the most common form of valve disease in the Western world. More than 5 million adults in the U.S. are estimated to have some form of aortic valve disease and some 15,000 die every year.1 For more information about patients with high Lp(a) and valve disease, visit www.TESTLpa.org. George Thanassoulis, MD MSc FRCP(C), Director of Preventive and Genomic Cardiology at the McGill University Health Center and Associate Professor at McGill University, Montreal, and a member of the Lipoprotein(a) Foundation’s Scientific Advisory Board, has been involved in three recent studies linking elevated levels of Lp(a) and aortic valve disease. The study “Estimating the Population Impact of Lp(a) Lowering on the Incidence of Myocardial Infarction and Aortic Stenosis,” was recently published in the American Heart Association journal, Arteriosclerosis, Thrombosis, and Vascular Biology. With potent Lp(a)-lowering therapies on the horizon, researchers sought to estimate the potential population impact of Lp(a) lowering that may be achieved by these therapies in primary prevention. Results showed that reducing high Lp(a) could potentially prevent up to 1 in 14 cases of myocardial infarction and 1 in 7 cases of aortic valve stenosis. “These data demonstrate that among those with high Lp(a), nearly one third of heart attacks and half of all cases of aortic stenosis can be attributed to high Lp(a) and may be preventable with Lp(a) lowering therapy. Lowering Lp(a) could significantly reduce the impact of cardiovascular disease,” said Dr Thanassoulis. In “Lipoprotein (a) in calcific aortic valve disease: from genomics to novel drug target for aortic stenosis,” published in the Journal of Lipid Research (DOI: 10.1194/jlr.R051870) and “Lipoprotein(a): new insights from modern genomics,” published in the January issue of Current Opinion in Lipidology (DOI:10.1097/MOL.0000000000000392), Dr Thanassoulis and colleagues identify Lipoprotein(a) as the strongest independent genetic risk factor for both myocardial infarction and aortic stenosis. According to Dr Thanassoulis, “With mounting epidemiological and genetic findings in support of Lp(a)-mediated valve disease, it is critical to discuss potential mechanisms underlying this observation, and outline the steps to translate this discovery to a much needed novel therapeutic strategy for AV disease. With novel therapies on the horizon, Lp(a) is poised to gain significant clinical relevance and its lowering could have a significant impact on the burden of CVD.” Dr Thanassoulis also announced that he just received a Research Project Grant (RO1) from the National Institutes of Health/ National Heart, Lung, and Blood Institute (NHLBI). The purpose of the grant, titled, “Genetic and molecular epidemiology of Lp(a)-mediated calcific aortic valve disease,” is to extend discovery of the role of Lp(a) in aortic stenosis. The objectives are to better understand the molecular determinants of Lp(a) mediated valve calcification and identify causal disease pathways that may be targeted by novel therapeutics. One in 5 people globally have inherited high Lp(a) - 63 million in the U.S.4 - and Lp(a) is currently the strongest monogenetic risk factor for coronary heart disease and aortic stenosis.2,3 Lp(a) concentrations can be measured by a simple blood test and could be the first step in preventing up to 120,000 cardiovascular events every year;1,5 however, it is not included in most standard lipid panel tests that check cholesterol levels.1 “There is a growing body of research that links high lipoprotein(a) to heart attacks, strokes and now aortic stenosis and heart valve disease. Studies likes the ones conducted by Dr Thanassoulis continue to demonstrate that high Lp(a) is the strongest independent genetic risk factor for many cardiac conditions and therapies under development could have tremendous impact. We are proud to support education and awareness of Heart Valve Disease and will continue to empower patients and prevent cardiovascular events due to high Lipoprotein(a) through proper testing and diagnosis,” said Sandra Revill Tremulis, founder of Lipoprotein(a) Foundation. Because approximately 63 million Americans have high Lipoprotein(a) and are at risk of premature cardiovascular disease, the vision for the foundation is: To live in a world where high Lipoprotein(a) is routinely diagnosed, treated and family screened. The mission is to prevent cardiovascular events due to high Lipoprotein(a) by diagnosing this inherited risk for cardiovascular disease; educating and empowering patients and saving lives. Our goal is to save lives by increasing awareness, advocating for routine testing, and supporting research that will lead to a specific treatment for elevated Lipoprotein(a). Based in San Carlos, California, the Lipoprotein(a) Foundation is a patient-founded, 501(c)3 non-profit organization. Learn more about Aortic Valve Disease and high Lp(a) visit: www.TESTLpa.org


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sanofi Genzyme, the specialty care global business unit of Sanofi, today announced the start of a Phase 2 trial of an investigational oral therapy for patients with Parkinson’s disease who carry a single copy of a gene mutation that is the most common genetic risk factor for the disease. The trial will assess the drug’s dynamics, efficacy and safety. This is the first industry-sponsored Phase 2 clinical trial in a genetically defined population of Parkinson’s disease. Parkinson’s disease is a chronic, degenerative neurological disorder affecting an estimated one million people in the United States and more than five million people worldwide.1 An estimated 5 – 10% of Parkinson’s disease patients carry a mutation of the glucocerebrosidase (GBA) gene that allows lipids called glycosphingolipids to build up in cells. The molecule being studied, GZ/SAR402671, reduces the production of glycosphingolipids. “ Patients with Parkinson’s disease and a GBA gene mutation are predisposed to develop motor symptoms at a younger age, have a higher prevalence of cognitive impairment and undergo more rapid disease progression,” explains Anthony Schapira, MD, DSc, FRCP, FMedSci, Head of Department of Clinical Neurosciences, UCL Institute of Neurology and Lead Principal Investigator for the study. “Investigating a targeted therapy for these patients is an important first step in addressing the serious unmet needs these patients and their families face in managing Parkinson’s disease.” The clinical trial, known as MOVES-PD, will be run in two phases: a dose escalation study followed by a study of efficacy and safety. The randomized, double blind study will enroll more than 200 patients at trial sites around the world. The primary endpoint of the study is the change in score from baseline in a scale commonly used to measure Parkinson’s disease progression known as the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II and III. This includes self-evaluation of daily life activities and motor experience, and a clinician-scored motor evaluation. “We are excited to be able to bring the results of our many years of research in GBA gene mutations to a new therapeutic area with the potential to benefit patients with Parkinson’s disease,” said Tanya Fischer, MD, PhD, Global Project Head of Early Development for Parkinson’s Disease and Movement Disorders, Sanofi R&D. “ We look forward to evaluating whether this molecule, which has been shown to cross into the brain in preclinical studies, may positively impact the devastating neurologic effects of this disease.” Sanofi has studied GBA gene mutations for more than 30 years. People with GBA mutations in both copies of the gene, as opposed to a single mutation in GBA Parkinson’s disease, have Gaucher disease. Gaucher disease is a rare genetic disorder in which the buildup of a lipid in the cells leads to a broad spectrum of systemic manifestations including bruising, fatigue, anemia, low blood platelets, bone and joint pain, enlargement of liver and spleen, as well as neurological manifestations such as seizures and incoordination in severe forms. Sanofi Genzyme introduced the world’s first treatment for Gaucher disease and Sanofi R&D remains committed to developing treatments for conditions associated with GBA mutations, including Gaucher disease and Parkinson’s disease. For more information on this trial, please visit https://www.clinicaltrials.gov/ or https://www.clinicaltrialsregister.eu. About Sanofi Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2015. 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