|Vitae Announces Top-Line Results From Metformin Arm of Ongoing Phase 2 Clinical Trial of BI187004/VTP-34072; Merck Announces Phase 3 Study of Single-Dose EMEND®|
|By David Fowler|
|Monday, 29 June 2015 20:11|
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 29, 2015.
Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company, today announced top-line clinical efficacy results from the metformin arm of an ongoing Phase 2 proof-of-concept clinical trial of BI187004/VTP-34072 in the treatment of overweight type 2 diabetic patients. BI187004/VTP-34072 is a potential first-in-class 11β-hydroxysteroid dehydrogenase type 1 (11β HSD1) inhibitor that was discovered by Vitae and is currently being developed by Boehringer Ingelheim GmbH (Boehringer Ingelheim), a leader in diabetes treatments and cardiometabolic research and development.
Safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of BI187004/VTP-34072 as monotherapy or as an add-on to metformin background therapy are being investigated over 28 days in a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Primary efficacy data (fasting plasma glucose) from the metformin arm did not meet Boehringer Ingelheim's predefined endpoint criteria. Data from the placebo-controlled monotherapy arm of the trial, which is still ongoing, are expected to be reported later this year. Together, these data sets will be used by Boehringer Ingelheim to determine appropriate next steps for BI187004/VTP-34072.
"The metabolically complex, overweight type 2 diabetic patient population is in need of novel mechanisms of action that can address their overall risk profile," said Dr. Richard Gregg, Chief Scientific Officer of Vitae. "We are anxious to learn more about BI187004/VTP-34072 when the study is completed and fully analyzed."
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase 3 study investigating the safety and efficacy of single-dose EMEND® (fosaprepitant dimeglumine) for Injection, Merck's substance P/neurokinin (NK-1) receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic (vomit-inducing) chemotherapy (MEC). In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose EMEND for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Annual Meeting on Supportive Care in Cancer (Abstract #27-02-O) in Copenhagen (June 25-27, 2015).
"The results from this important Phase 3 trial are very encouraging as they are the first study to evaluate EMEND for Injection in a combination regimen for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy – and show the potential to use a single day antiemetic regimen," said Dr. Bernardo L. Rapoport, principal investigator for the study and chief medical oncologist, Medical Oncology Centre of Rosebank, Johannesburg, South Africa.
"Nausea and vomiting remain a significant burden for patients receiving chemotherapy and we look forward to submitting these data for EMEND for Injection to the U.S. Food and Drug Administration," said Stuart Green, vice president, clinical research, Merck Research Laboratories. "This study builds on our decade of research for EMEND and Merck's overall commitment to help people with cancer."
EMEND for Injection, a substance P/Neurokinin-1 (NK1) receptor antagonist approved for use in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer (HEC) chemotherapy, including high-dose cisplatin; and for prevention of nausea and vomiting associated with initial and repeat courses of MEC. EMEND has not been studied for treatment of established nausea and vomiting. Chronic continuous administration of EMEND is not recommended.
In the U.S., the single-dose regimen of EMEND for Injection is approved for use associated with HEC. Merck plans to submit these recent data to the Food and Drug Administration in the second half of 2015 to seek approval for a regimen containing single-dose EMEND for Injection for the prevention of CINV associated with MEC.
About Phase 3 Study for Single-Dose EMEND for Injection in MEC -- In this global randomized, Phase 3, double-blind study, more than 1,000 patients receiving MEC were randomly assigned to receive either single-dose EMEND for Injection (150 mg) in combination with ondansetron capsules (16 mg) and dexamethasone capsules (12 mg) (n=504) on day one (followed by oral placebo for ondansetron on days two and three) or an active control regimen consisting of placebo (saline IV) in combination with ondansetron (16 mg) and dexamethasone (20 mg) (n=497) on day one (followed by 8 mg ondansetron on days two and three). The primary endpoint of the study was complete response (CR) (as measured by no vomiting and no use of rescue medication for nausea or vomiting) in the delayed phase (25 to 120 hours following initiation of chemotherapy). The secondary endpoints were CR after the first dose of chemotherapy in the acute phase (0 to 24 hours) and in the overall phase (0-120 hours), as well as no vomiting in the overall phase.
Single-Dose EMEND for Injection Regimen Achieved Superior Control of CINV -- For the primary study endpoint, EMEND for Injection regimen provided higher incidence of CR in days 2 through 5 – with CR observed in 78.9 percent of patients receiving the EMEND for Injection regimen versus 68.5 percent in the active control group (p <0.001). For the secondary endpoints, in the acute phase, CR was observed in 93.2 percent of patients receiving the EMEND for Injection regimen versus 91 percent in the active control group (p = 0.184). In the overall phase, the incidence of CR was observed in 77.1 percent of patients receiving the EMEND for Injection regimen versus 66.9 percent in the active control group (p <0.001). Additionally, a significantly greater proportion of patients receiving the EMEND for Injection regimen experienced no vomiting in the overall phase (82.7 percent with EMEND vs 72.9 percent in the active control group) and delayed phase (83.9 percent with EMEND vs 75.1 percent in the active control group) (both p <0.001) – with a favorable trend in the acute phase (94.8 percent with EMEND vs 92 percent in the active control group).
Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received confirmation from the United States Department of Justice that it has closed its investigation into the company’s marketing of the Impella® 2.5 device without taking enforcement action.
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it will visit the Nasdaq MarketSite in Times Square on Monday, June 29th.
Alliqua BioMedical, Inc. (NASDAQ:ALQA), a provider of advanced wound care products, will ring the opening bell at the Nasdaq Stock Market in Times Square to celebrate the Company's acquisition of Celleration, which closed on May 29, 2015.
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced the successful completion of a diesel demonstration program with Volkswagen of America, Inc. that was designed to test the commercial readiness of Amyris renewable diesel and its ability to enhance VW's innovative and advanced diesel technology.
The University of Alabama at Birmingham, home to the UAB Health System and the third largest academic medical center in the United States, and athenahealth, Inc. (NASDAQ:ATHN), a leading provider of cloud-based services and mobile applications for medical groups and health systems, today announced that they will work together to improve care coordination in the ambulatory space.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the submission of a New Drug Application (NDA) for drisapersen for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is December 27, 2015.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced it has completed the previously announced acquisition of Blackbird Bio Finance and University of South Florida's ("Licensor") next generation GVAX vaccine's ("CD40LGVAX") related technologies and technical knowledge.
Connecture, Inc. (NASDAQ:CNXR), a provider of web-based information systems used to create health insurance marketplaces, announced that the company will be presenting a two-part webinar series, with part one occurring on Tuesday, June 30 at 12:00 p.m. CDT.
Fibrocell Science, Inc. (Nasdaq:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that the company has been added to the Russell 2000® Index as part of Russell Investments' annual reconstitution that took place after the market closed on June 26, 2015.
FibroGen, Inc. (Nasdaq:FGEN), a research-based biopharmaceutical company, announced today that it has received a scheduled $120.0 million non-contingent license payment from AstraZeneca AB ("AstraZeneca") under its collaboration agreements with AstraZeneca for roxadustat in the United States, China and certain other territories.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, today announced the achievement of two important regulatory milestones for obeticholic acid (OCA) in primary biliary cirrhosis (PBC): submission of a New Drug Application (NDA) for accelerated approval to the U.S. Food and Drug Administration (FDA) and acceptance of the Marketing Authorization Application (MAA) by the European Medicines Agency (EMA).
Kips Bay Medical, Inc. (OTCQB:KIPS) today announced its decision to terminate its eMESH I clinical feasibility trial due to poor early angiographic results from enrolled patients who had an eSVS Mesh implanted using the new surgical implant technique and its intention to effect an orderly wind down of its operations.
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced top-line 52-week safety results from its Study of Oral Androgen Replacement ("SOAR") pivotal Phase 3 clinical study (http://clinicaltrials.gov/show/NCT02081300) evaluating efficacy and safety of LPCN 1021, an oral testosterone product candidate, in hypogonadal men with low testosterone.
Prothena Corporation plc (Nasdaq:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapy programs, today announced the appointment of Anders Härfstrand, MD, PhD, to its Board of Directors.
OncoMed Pharmaceuticals, Inc., (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced the appointment of Rick Winningham to the company's Board of Directors.
SANUWAVE Health, Inc. (OTCQB:SNWV), a shockwave technology company, announced today that Kevin A. Richardson II, SANUWAVE's Chairman of the board and Chief Executive Officer, will present at the 2015 Landmark Venture Forum, hosted by Landmark Angels, Inc., being held Tuesday, June 30 at the offices of Marcum LLP in Boston MA.
TOMI™ Environmental Solutions, Inc. (OTCQB:TOMZ), a global bacteria decontamination and infection prevention company, announced the company has retired $5 million in outstanding convertible debt, resulting in the company becoming completely debt free.
Zosano Pharma Corporation (NASDAQ:ZSAN) announced today that Vikram Lamba, Chief Executive Officer, will provide a company overview at the Cantor Fitzgerald Inaugural Healthcare Conference on July 8, 2015.