|Oxygen Biotherapeutics Announces Halt of Oxycyte Phase IIb Traumatic Brain Injury Trial; Biogen Announces Five-Year Results from ENDORSE Phase 3 Study|
|By Josh Gee|
|Thursday, 11 September 2014 19:05|
“With the difficulties we have had enrolling patients at the current Phase IIb clinical sites for Oxycyte, the Oxygen Board of Directors and management team has decided that completing this trial in a reasonable period of time is not feasible,” said Dr. Ronald Blanck, Chairman of the Oxygen Board of Directors. "We will be considering strategic alternatives for Oxycyte moving forward.”
Oxycyte, a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier, was in clinical and preclinical studies for intravenous delivery in indications such as traumatic brain injury, decompression sickness and stroke. The current Phase IIb study was evaluating the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI).
The Company will be focusing resources on its lead critical care product, levosimendan, a calcium sensitizer in Phase 3 development in the United States for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS).
In July 2014, Oxygen initiated a Phase 3 trial in the United States to evaluate levosimendan in cardiac surgery patients at risk of developing LCOS. The FDA has granted Fast Track status for levosimendan in this indication.
Biogen Idec (NASDAQ: BIIB) announced that five-year results from the ENDORSE Phase 3 extension study show TECFIDERA® (dimethyl fumarate) provides strong and sustained efficacy in a broad range of people living with relapsing-remitting multiple sclerosis (RRMS). These data will be presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRIMS).
Across all patients in the ENDORSE study who received TECFIDERA, including some patients who were treated for up to seven and a half years, the safety profile remained consistent with no new or worsening safety signals. Additional analyses in patients who were newly diagnosed with multiple sclerosis (MS) when the parent studies DEFINE and CONFIRM began indicate that TECFIDERA had a robust long-term effect on MS relapse rates, disability progression and MRI measures in these patients.
“TECFIDERA continues to provide patients with effective oral treatment for MS that is supported by a growing body of data reinforcing its benefits and favorable safety profile,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. “These new ENDORSE results provide further insight into the positive impact of using TECFIDERA early in the course of MS and for long-term treatment of this chronic disease.”
ENDORSE Clinical Efficacy and MRI Outcomes - ENDORSE is a global, dose-blind extension study evaluating the long-term safety and efficacy of TECFIDERA (240 mg, dosed twice a day [BID] or three times a day [TID]). Patients who received up to two years of TECFIDERA in the pivotal Phase 3 DEFINE and CONFIRM studies continued on the same dose in ENDORSE. Patients who previously received placebo or glatiramer acetate (GA; 20 mg subcutaneous daily injection; CONFIRM only) in DEFINE and CONFIRM were randomized 1:1 to TECFIDERA BID or TID.
At five years (two years in DEFINE or CONFIRM and three years in ENDORSE), interim results show that patients who continued on TECFIDERA BID treatment experienced sustained clinical efficacy on relapse and disability progression endpoints as measured by annualized relapse rate (ARR) and 24-week Expanded Disability Status Scale (EDSS), similar to what was observed after two years in DEFINE and CONFIRM. These patients also maintained a low frequency of brain lesions over five years as measured by new or enlarging T2-hyperintense lesions, new non-enhancing T1-hypointense lesions and gadolinium-enhanced [Gd+] lesions.
An analysis of data from ENDORSE evaluated the long-term efficacy of TECFIDERA in newly diagnosed patients, defined as those diagnosed within one year prior to enrolling in DEFINE or CONFIRM and either disease modifying treatment-naïve or previously treated with corticosteroids alone.
Over the five-year observation period, newly diagnosed patients taking TECFIDERA BID experienced sustained reductions in relapses (measured by ARR and proportion of patients who relapsed), disability progression (measured by 24-week EDSS) and number of brain lesions. These effects are similar to the results reported for the overall ENDORSE study population, supporting the consistent efficacy of TECFIDERA in this subpopulation.
“As shown in the ENDORSE study, TECFIDERA provides consistent outcomes across a broad range of relapsing-remitting MS patients, including those who are newly diagnosed, highlighting its utility in the range of patients we see in practice,” said Ralf Gold, M.D., professor and chair of the Department of Neurology at St. Josef-Hospital, Ruhr-University in Bochum, Germany. “The long-term efficacy of TECFIDERA in reducing key measures of disease activity and its favorable safety profile help support its role as an important therapeutic option for people living with MS.”
Effect of TECFIDERA on No Evidence of Disease Activity - Another analysis from ENDORSE evaluated the long-term effects of TECFIDERA on the emerging measure of No Evidence of Disease Activity (NEDA) over five years. Patients were assessed annually and were considered to have NEDA if they had: no relapses, no 24-week confirmed disability progression, no Gd+ lesions, and no new or enlarging T2-hyperintense lesions.
Results over five years show that the proportion of patients achieving NEDA annually was maintained in patients who continued on TECFIDERA, and was improved in patients who switched from placebo to treatment with TECFIDERA BID in the ENDORSE study.
ENDORSE Safety - The safety profile of TECFIDERA observed in ENDORSE was consistent with the favorable findings reported in the DEFINE and CONFIRM studies. There were no new or worsening safety findings observed in patients who continued treatment with TECFIDERA from DEFINE and CONFIRM or in patients who switched to TECFIDERA therapy after the conclusion of the pivotal studies.
All patients in ENDORSE had received treatment with TECFIDERA for at least five years if previously on TECFIDERA in DEFINE or CONFIRM, including some patients who had received TECFIDERA for up to seven and a half years cumulatively. Patients previously on placebo in DEFINE or CONFIRM had received TECFIDERA in ENDORSE for at least three years. The most common adverse events in patients who switched to TECFIDERA from placebo or GA were flushing and gastrointestinal (GI) events, the incidences of which were generally similar to what was observed in DEFINE and CONFIRM. In patients continuing on TECFIDERA therapy, the most common adverse events were MS relapse and nasopharyngitis (common cold).
In patients continuing on, or new to, TECFIDERA treatment there was no overall increased risk of serious infections (including opportunistic infections) or malignancies. There was no overall increased risk of renal dysfunction, urinary events or hepatic adverse events in any treatment group; and mean white blood cell and lymphocyte counts remained stable.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that it has priced a public offering of 13,725,490 shares of its common stock at a price to the public of $2.55 per share.
Akebia Therapeutics, Inc. (Nasdaq:AKBA), a biopharmaceutical company focused on the development of novel, proprietary therapeutics based on hypoxia-inducible factor (HIF) biology and the commercialization of these products for patients with kidney disease, will visit the NASDAQ MarketSite in Times Square.
Alameda Health System (AHS) has announced that a total of 263 employees were honored for their dedicated service at the Annual Employee Awards Banquet, which took place on September 5, 2014.
Avalanche Biotechnologies, Inc. (Nasdaq:AAVL), a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today reported financial results and operational highlights for the quarter ended June 30, 2014.
Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR), a leader in functional, renewable plant-based proteins, is pleased to announce the results from its 2014 annual and special meeting of shareholders held on September 10, 2014.
Egalet Corporation (Nasdaq:EGLT) today announced the issuance of patents by the U.S. Patent and Trademark Office (USPTO) covering Egalet's product candidates and the Company's proprietary Guardian Technology.
LifeVantage Corporation (Nasdaq:LFVN), is hosting its first-ever exclusive 3-day Rules of Engagement seminar designed to teach, train and mentor their young entrepreneur Distributors.
Marrone Bio Innovations, Inc. (Nasdaq:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced that it has received a patent for the use of Chromobacterium, a naturally occurring bacterium with demonstrated insecticidal and miticidal capabilities.
MRI Interventions, Inc. (OTCQB:MRIC) today announced that medical device veteran Frank Grillo will become the company's new Chief Executive Officer. Grillo will join MRI Interventions as President on October 6, 2014 and will become CEO on January 1, 2015.
Nature's Sunshine Products, Inc. (Nasdaq:NATR), a leading natural health and wellness company engaged in the manufacture and direct selling of nutritional and personal care products, today announced that Stephen Bunker, Executive Vice President, Chief Financial Officer and Treasurer, will participate in two upcoming investor conferences: Imperial Capital's 8th Annual Global Opportunities Conference to be held September 18, 2014 at the Waldorf Astoria in New York, NY. Nature's Sunshine Products' presentation is scheduled to take place on Thursday, September 18, 2014 at 1:45 p.m. ET and Wedbush Securities' California Dreamin' Consumer Conference: "The NY Edition" to be held September 23, 2014 at Le Parker Meridien in New York, NY. Nature's Sunshine Products' presentation is scheduled to take place on Tuesday, September 23, 2014 at 8:35 a.m. ET.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today that the Company has entered into an exclusive license agreement with The Rockefeller University for patented technologies that further expand the Company's intellectual property portfolio associated with its Targeted Cancer Immunotherapy Program.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, announced that it will host its 2nd annual Analyst and Investor Meeting to be held on Tuesday, September 23, 2014 from 9:00 a.m. – 11:00 a.m. (ET) in New York, NY.
Radius Health, Inc. (Nasdaq:RDUS) announced today that its President and CEO, Robert Ward, will present at the BioCentury NewsMakers in the Biotech Industry Conference on Friday, September 26, 2014 at 2:00 p.m. Eastern Time at the Millennium Broadway Hotel & Conference Center in New York.
Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, financial services, medical equipment, and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced the opening of a $2 million revolving line of credit with Wells Fargo bank at attractive terms.
TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) announced today that its Chief Executive Officer, Elias Vamvakas, will present an update on the Company's business at the 5th Annual Craig-Hallum Alpha Select Conference on Thursday, September 18, 2014 at 2:50 p.m. Eastern Time at the Convene Conference Center in New York City.
ZS Pharma (Nasdaq:ZSPH), a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, today announced that a secondary analysis of data from ZS003, a pivotal Phase 3 trial of ZS-9 (sodium zirconium cyclosilicate), its investigational treatment for hyperkalemia, will be presented in an oral presentation during the Late-Breaking Clinical Trial Session at the Heart Failure Society of America (HFSA) 18th Annual Scientific Meeting in Las Vegas on September 15, 2014.