|GTx's Phase III Clinical Studies of Enobosarm (GTx-024) to Continue as Planned; Luminex Receives U.S. FDA Clearance for MAGPIX®|
|By Staff and Wire Reports|
|Monday, 15 April 2013 19:09|
GTx (Nasdaq: GTXI) announced a per protocol safety review of unblinded safety data on Friday April 12, 2013, by an independent Data Safety Monitoring Board (DSMB), resulted in a determination that GTx continue as planned its two pivotal Phase III clinical trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer. The DSMB has met regularly every six months to review safety data from the two pivotal Phase III clinical trials and will not meet again until the data is locked and unblinded for a final assessment of safety data from the two studies.
"We are pleased that the DSMB has recommended that GTx continue as planned with our clinical studies of enobosarm under the existing protocols,” said Mitchell S. Steiner, MD, Chief Executive Officer of GTx. “The extensive safety database GTx is compiling from the numerous clinical studies of enobosarm will be a critical component of GTx's application for marketing approval, which we hope to submit following receipt of topline data from our Phase III clinical trials in the 3rd quarter of 2013."
GTx has completed enrollment of approximately 650 subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III studies are being conducted in clinical sites in the United States, Europe, Russia and South America. In each of the placebo-controlled, double-blind clinical trials, approximately 325 patients with Stage III or IV non-small cell lung cancer have been randomized to oral daily doses of placebo or enobosarm 3 mg at the time they begin first line standard chemotherapy. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint at five months of treatment. Topline data from the studies should be released during the third quarter of 2013.
Luminex Corporation (NASDAQ: LMNX) announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP). This is the first clinical assay to be cleared on MAGPIX. xTAG GPP is the first U.S. IVD cleared test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample.
"Receiving FDA clearance of MAGPIX opens the door for clinical laboratories of all sizes to use xTAG GPP on this innovative instrument," said Patrick J. Balthrop, president and chief executive officer of Luminex. "By bringing a compact, cost-effective, easy-to-deploy multiplexing solution to the clinical market, MAGPIX makes molecular testing more accessible to all laboratories."
Based on Luminex's xMAP® Technology, the easy-to-use MAGPIX instrument is a versatile multiplexing platform capable of performing qualitative and quantitative analysis of proteins and nucleic acids in a variety of sample matrices. MAGPIX is compact making it attractive to laboratories with limited bench space. This affordable system can perform up to 50 different tests in a single reaction volume, greatly reducing sample input, reagents, and labor while improving productivity.
Traditional GI testing technologies and methods can take several days to deliver a single result depending on the pathogen. xTAG GPP is capable of delivering multiple results within five hours. Simultaneous molecular testing on a single sample within a single shift provides significant benefits to laboratories in terms of workflow and resource utilization.
"Tests such as the xTAG GPP that can detect viruses, bacteria, and parasites from one sample at the same time can help clinicians more quickly identify and treat what's causing gastroenteritis," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiology at the FDA's Center for Devices and Radiological Health in an FDA press release when xTAG GPP was first approved by the Agency. "The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks."
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