|FDA Approves New U.S. Labeling for ISENTRESS® (raltegravir); Oxygen Announces Progress in its Phase IIb Clinical Trial of Oxycyte|
|By Staff and Wire Reports|
|Monday, 01 July 2013 19:35|
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets, Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination HIV therapy. The updated prescribing information now includes 240-week results from the STARTMRK study, the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adult patients with HIV-1 infection. The results show that the regimen containing ISENTRESS in combination therapy demonstrated long-term viral suppression and a greater immunologic response than the efavirenz-containing regimen, as well as a proven, long-term safety and tolerability profile through 240 weeks in previously untreated (treatment-naïve) adult HIV-1 infected patients.
ISENTRESS is an integrase inhibitor indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class ARV [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adult patients through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.
The use of other active agents with ISENTRESS (raltegravir) is associated with a greater likelihood of treatment response.
Severe, potentially life-threatening and fatal skin reactions have been reported with ISENTRESS. Additionally, during the initial phase of combination ARV treatment, immune reconstitution syndrome may occur. (See Important Selected Safety Information below.)
“As the care of HIV evolves, ISENTRESS continues to be an important treatment option for adult patients with HIV-1,” said Jürgen Rockstroh, M.D., University of Bonn, Bonn-Venusberg, Germany. “These 240-week results are important for physicians to consider when initiating treatment with ISENTRESS in combination therapy in treatment-naïve adult patients with HIV-1.”
“Merck has been at the forefront of HIV research for close to 30 years. The discovery of ISENTRESS and its clinical development program are a testament to Merck's long-term commitment to the research and development of medicines for HIV,” said Daria Hazuda, Ph.D., vice president of Early Development and Discovery Sciences Research for infectious diseases, Merck.
Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) announced enrollment of the first subject in the second cohort of its global Phase IIb clinical trial to investigate the safety and tolerability of Oxycyte® in patients with severe, non-penetrating traumatic brain injury (“STOP-TBI”). The first patient of the second cohort was enrolled in Israel at the Rambam Health Care Campus (RHCC) - the only Level 1 trauma center in the north of Israel. The RHCC's neurotrauma center treats approximately 200 severe brain injuries annually and is recognized as a teaching center of excellence for the region. The neurotrauma center is led by Dr. Leon Levi who, together with Department of Neurosurgery Chief, Professor Menashe Zaaroor, serve as co-principal investigators in the STOP-TBI trial.
The first cohort, of the three-cohort study, concluded with an independent safety monitoring board recommending, unanimously, advancement to Cohort 2. In addition to the 5 study centers receiving ethics committee approval in Israel, the study is expected to include sites in Switzerland, France and Spain, as well as other countries to be named later.
Dr. Levi, who is Oxygen Biotherapeutics' National Advisor in Israel for the study, recently commented, “The neurosurgical department at RHCC is proud to be a part of the research with Oxycyte as a treatment for TBI. We look forward to productive work on this important study.”
“With this first patient, we've officially begun our second cohort in the Phase IIb clinical trial in Israel and Switzerland,” stated Michael Jebsen, Interim CEO, President and Chief Financial Officer. “Each milestone that moves us towards regulatory approvals for Oxycyte® is a result of the commitment we've made to focus on this critical TBI indication for treatment markets both in the U.S. and internationally, where there are currently no approved treatments for any phase of TBI. We are pleased to be working with the top neurosurgeons and thought leaders in the world who seek advanced methods to treat and prevent critical medical conditions resulting from TBI.”
The STOP-TBI trial is a randomized, double-blind, placebo-controlled dose-escalation study of Oxycyte®. The primary objective of the trial is to evaluate the safety and tolerability of Oxycyte® in patients with severe non-penetrating traumatic brain injury. The secondary objective is to assess the potential of Oxycyte® in ameliorating the severity of TBI and represents an opportunity for the collection of placebo-controlled efficacy data, specifically, clinical and functional improvement. Functional status will be measured by the Glasgow Outcome Scale - Extended (GOS-E), a validated tool that helps to assess progress in patient recovery from their injury.
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