GTx's Phase III Clinical Studies of Enobosarm (GTx-024) to Continue as Planned; Luminex Receives U.S. FDA Clearance for MAGPIX® Print E-mail
By Staff and Wire Reports   
Monday, 15 April 2013 19:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 15, 2013.

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.


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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."



Also Monday:



Abbott (NYSE: ABT)
today announced it is initiating a voluntary recall of FreeStyle InsuLinx® Blood Glucose Meters in the United States.

Advanced Cell Technology, Inc. (OTCBB: ACTC)
, a leader in the field of regenerative medicine, today announced treatment of the first patient in patient cohort 2a, consisting of patients with better vision, in its U.S. clinical trial for Stargardt’s Macular Dystrophy (SMD), a form of juvenile macular degeneration.

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") announced today that David A. Dodd has been appointed President and Chief Executive Officer of the Company, succeeding Juergen Engel, PhD.

AlphaRx Inc. (OTCQB: ALRXF)
, today announced that effective April 15, 2013 its name will become UMeWorld Limited, and its common shares will continue to be quoted by the OTC Markets OTCQB with its current symbol ALRXF as of the market open.

AtheroNova Inc. (OTCBB: AHRO)
, a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that John J.P. Kastelein, MD, PhD, Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center and Strategic Chair of Genetics in Cardiovascular Disease at the University of Amsterdam, has joined the Company as a member of the Medical Advisory Board and will be a Co-Principal Investigator in the Company's upcoming clinical trials.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, today announced the launch of a new National Awareness Program, including a video to educate women and health care providers on the prevention of breast cancer by early testing for pre-cancerous breast conditions using The ForeCYTE Breast Health Test.

The Board of Elan Corporation, plc (NYSE: ELN)
(Elan) notes this morning’s announcement regarding the offer by Echo Pharma Acquisition Limited (“Royalty Pharma”) to acquire Elan's shares under Rule 2.5 of the Irish Takeover Rules.

Fibrocell Science, Inc. (OTC: FCSC)
today announced that its Phase 2 study to evaluate the safety and efficacy of azficel-T (LAVIV®) for the treatment of patients with moderate-to-severe acne scars has been accepted for publication in Dermatologic Surgery, the peer-reviewed journal of the American Society for Dermatologic Surgery.

Immunotech Laboratories, Inc. (PINKSHEETS: IMMB)
announces the company has appointed Blaine Nabors as VP of Business Development.

IsoRay Inc. (NYSE MKT: ISR) (NYSE AMEX: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth at the Annual Meeting of the American Brachytherapy Society (ABS).

Luminex Corporation (NASDAQ: LMNX)
today announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel (xTAG GPP).

MetaStat, Inc. (OTCBB: MTST)
, a life science company focused on understanding and treating systemic metastasis, announced today the appointment of David Epstein, Ph.D. as Advisor for MetaStat's Drug Discovery & Development efforts.

MMRGlobal, Inc. (OTCQB: MMRF)
("MMR") today announced that the United States Patent and Trademark Office has issued a Notice of Allowance for the Company's anti-CD20 monoclonal antibody assets, U.S. Serial No. 11/855,943, under the title, "Antibodies and Methods for Making and Using Them."

Parametric Sound Corporation (NASDAQ: PAMT)
, a leading innovator of audio products and solutions, today announced the Company plans to release financial results for its second quarter ended March 31, 2013 after the Market closes on Thursday, May 2, 2013.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR)
today announced that it will release first quarter 2013 financial results on Tuesday, April 30, 2013 after the close of the U.S. financial markets.

Star Scientific, Inc. (NASDAQ: STSI)
is proud to congratulate its Anatabloc® brand ambassadors, Fred Couples and John Isner, for their exceptional performances over the weekend at the Masters Tournament in Augusta, Georgia, and the US Men's Clay Court Championship in Houston, Texas.

Vycor Medical, Inc. (OTCBB: VYCO)
announced today that it has finalized the production and the U.S. commercial launch of an extension arm for its existing ViewSite™ Brain Access System ("VBAS") product range.

Xplore Technologies Corp. (NASDAQ: XPLR)
, the manufacturer of the world’s most powerful, longest-lasting and rugged tablet on the market, and Novatek International announced the Novatek EM-Mobile, the latest environmental monitoring mobile application.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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