GTx Shares Halted After Reports of Poor Results for Enobosarm POWER Trials, Supernus Reports Final FDA Approval of Trokendi XR Print E-mail
By Staff and Wire Reports   
Monday, 19 August 2013 19:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 19, 2013.

GTx, Inc. (Nasdaq: GTXI)
announced results of its two Phase 3 enobosarm clinical trials, the POWER trials, in patients with non-small cell lung cancer (NSCLC) receiving chemotherapy. The Company announced that the clinical trials failed to meet the overall criteria for the co-primary responder endpoints of lean body mass and physical function as agreed upon with the United States Food and Drug Administration (FDA); the responder endpoints showed mixed results (for POWER1 and POWER2, p values at Day 84 for LBM were 0.036 and 0.113, respectively; p values at Day 84 for SCP were 0.315 and 0.289, respectively).

Initial exploratory quantitative (continuous variable) analysis demonstrated that enobosarm had a consistent effect on LBM relative to placebo in both studies at all assessment times (p values were 0.0003 and 0.0227 at Day 84 for POWER1 and POWER2, respectively). Corresponding analyses for SCP were inconsistent between trials (p values were 0.0336 and 0.7923, respectively). Missing data were well balanced between the arms in both trials for both endpoints. Across both clinical trials, enobosarm was generally well tolerated, with the occurrence of serious adverse events and overall incidence of adverse events similar across placebo and treatment groups.

In POWER1, the four most common adverse events reported (in decreasing order of incidence) were nausea, alopecia, anemia and vomiting. In POWER2, the four most common adverse events reported were anemia, nausea, neutropenia and vomiting. In the safety analysis of survival, there was no evidence of a difference between patients treated with enobosarm and placebo in either clinical trial. "While we are disappointed that both studies did not meet the pre-specified responder analyses, we are encouraged by the unambiguous effect of enobosarm on muscle and we are confident that it will translate to clinical benefit and potentially increase survival in patients with non-small cell lung cancer," said Mitchell Steiner, M.D., CEO of GTx. "We look forward to sharing our clinical data from these and previous trials with FDA and European authorities to discuss the path forward. I would like to personally thank all the employees at GTx for their tremendous effort in conducting two high quality Phase 3 clinical studies and the principal investigators and their staff at over 80 clinical sites in 8 countries for their help recruiting and managing these studies. Most of all, I want to thank the patients with non-small cell lung cancer who participated in the POWER1 and POWER2 clinical trials in order to make it possible for future patients to potentially have access to important therapies."

Published observational data suggest that LBM is related to survival outcome. This observational finding has been replicated based on exploratory analysis of current survival data from the POWER studies using landmark analysis and time-dependent covariate Cox regression modeling that includes LBM response and arm as covariates. The effect size and direction were similar in both trials. GTx plans to initiate discussions with both the FDA and European regulatory authorities to determine the path forward. "Muscle wasting in patients with non-small cell lung cancer is devastating and unfortunately it affects hundreds of thousands of patients worldwide," said Jeffrey Crawford, M.D., Chief, Division of Medical Oncology at Duke University School of Medicine, and principal investigator for the POWER1 and POWER2 trials. "While some of the pre-specified primary endpoints were not met, I am encouraged by the substantial and consistent effect of enobosarm on muscle in these patients with lung cancer receiving chemotherapy." "Data from the POWER trials provide compelling evidence that enobosarm maintains or increases muscle," said Carla Prado, Ph.D., Assistant Professor, Nutrition, Food and Exercise Sciences at Florida State University. "Loss of muscle, independent of weight loss, is a common and often occult feature of cancer, and is acknowledged as a remarkable and powerful prognostic indicator of shorter survival."

About The POWER Trials A 3 mg dose of enobosarm was studied in two Phase 3 clinical trials to prevent and treat muscle wasting in patients with NSCLC. In each of these placebo controlled, double blind clinical trials, approximately 325 patients with stage III or IV NSCLC were randomized to oral daily doses of placebo or enobosarm 3 mg at the time they began first-line standard platinum doublet chemotherapy. The POWER trials were designed to assess the response rates of enobosarm versus placebo for the co-primary endpoints at 3 months of treatment on maintenance or improvement of total lean body mass (muscle) assessed by Dual-energy X-ray Absorptiometry (DXA) and improvement in physical function measured by the stair climb test (power). Durability of enobosarm treatment was assessed at five months. Secondary endpoints included an assessment of whether enobosarm-treated patients had an improved quality of life and reduced healthcare resource utilization compared to placebo. Overall survival is being assessed as an additional safety endpoint. GTx announced early this year that the FDA has designated enobosarm for the prevention and treatment of muscle wasting in patients with NSCLC as a Fast Track development program.


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Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN)
, a specialty pharmaceutical company, received final approval from the Food & Drug Administration (the "FDA") for Trokendi XR, a novel once-daily extended release formulation of topiramate for the treatment of epilepsy. The company expects to launch the product and for it to be available in pharmacies over the next few weeks.

The approval letter states that the FDA has completed its review of the application and that Trokendi XR is approved effective August 16, 2013 for use as recommended in the agreed-upon labeling. The FDA granted a waiver for certain pediatric study requirements and a deferral for submission of post-marketing pediatric pharmacokinetic assessments that are due in 2019 followed by clinical assessments in 2025.



Also Monday:



ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, announced the appointment of Terrence Moore as Executive Vice President and Chief Commercial Officer, effective today.

Amarantus BioScience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced the Company has entered into an equity financing arrangement with Dominion Capital to settle approximately $1,200,000 in accounts payable in exchange for Series D Preferred Shares of the Company.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, applauds the decision by National Institute for Health and Care Excellence (NICE) to issue updated guidance for the treatment of varicose veins.

BIOLASE, Inc. (NASDAQ: BIOL)
, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today disclosed that BIOLASE®projects that net cash used in operating activities will total $3.5 million to $4.5 million for the year ending December 31, 2013, compared to cash used in operating activities of $1.7 million for the year ended December 31, 2012.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX)
, a biopharmaceutical development company, announced today the appointment of B. J. Bormann, Ph.D., to its Board of Directors.

CNS Response, Inc. (OTCBB:CNSO)
today announced that all 25 of its note holders who have held convertible notes issued between October 2010 and February 2012 have agreed to convert $7.8 million of principal and interest into common stock.

The Clorox Company (NYSE: CLX) today announced the election of Esther Lee to its board of directors.

DARA BioSciences, Inc. (NASDAQ: DARA)
, a specialty pharmaceutical company focused on the commercialization of its complementary product portfolio of oncology and oncology supportive care products, announced today that it has entered into an "At-the-Market" ("ATM") Sales Agreement, dated August 19, 2013, with BTIG, LLC ("BTIG"). Pursuant to the agreement the Company may sell from time to time, under its effective registration statement on Form S-3, up to $2.73 million in aggregate offering price of its common stock, par value $0.01, per share through BTIG, acting as sales agent.

Guar Global Ltd. (OTCQB: GGBL)
, a company aiming to implement innovative technologies and methods to increase crop yields of guar, an organic gelling agent used extensively in hydraulic fracturing by the oil and gas sector, is pleased to confirm the appointment of Mr. Ganesh Prajapat as General Manager of India based operations.

HedgePath Pharmaceuticals, Inc. (OTCPink:HPPI)
announced today that it has completed a series of transactions to effectuate the reorganization of Commonwealth Biotechnologies, Inc. (CBTI) and CBTI's exit from its previously announced Chapter 11 proceedings via a Plan of Reorganization that will enable HPPI to operate as a public company.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
a biopharmaceutical company with a portfolio of patient-targeted, first-in-class, monoclonal antibodies (mAbs) to treat serious medical conditions with a primary clinical focus on severe respiratory diseases and cancer, announced today its corporate highlights and financial results for the second quarter ended June 30, 2013.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced today that Institutional Shareholder Services, Inc. ("ISS") and Glass, Lewis & Co., LLC ("Glass Lewis"), two leading independent proxy firms have both recommended that Medicago shareholders vote FOR the proposed acquisition by 9284-9686 Québec Inc. (the "Purchaser"), a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation ("MTPC"), of all common shares of Medicago not held by MTPC and Philip Morris Investments B.V. ("PMI") for a cash consideration of $1.16 per common share, pursuant to the terms of a plan of arrangement involving Medicago, MTPC, and the Purchaser (the "Arrangement").

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to inform shareholders and the general public that HempMedsPX—the master distributor and contracted marketing company for the Medical Marijuana, Inc. corporate portfolio—will be attending and exhibiting at the Michigan Medical Marijuana Conference August 23-25 in Ann Arbor, Michigan.

MMRGlobal, Inc. (OTCQB: MMRF)
, a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that as a result of China's participation in the Patent Prosecution Highway Program and the issuance of patents to MMR for its anti-CD20 monoclonal antibodies in the U.S., the Company has received confirmation from China of the filing on August 15, 2013 of a divisional Chinese patent application, No. 200780051557.6 entitled "Antibodies and Methods For Making and Using Them."

National Research Corporation (NASDAQ: NRCIA|NRCIB)
announced today that its Board of Directors has set forth the company's use of cash, including future cash dividends.

Pegasystems Inc. (NASDAQ: PEGA)
, the leader in Business Process Management (BPM) and a leading provider of Customer Relationship Management (CRM) solutions, today announced that the Third Annual Pega Collaborative Healthcare Summit will take place September 9-10, at the Royal Sonesta Hotel Boston.

PLX Technology, Inc. (NASDAQ: PLXT)
, the global leader in PCI Express® (PCIe®) silicon and software connectivity solutions enabling emerging data center architectures, today announced Jack Regula, PLX® chief scientist, has been selected to present at next week's HOT CHIPS Symposium.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia RSV FIA test for use with the Sofia Analyzer for the rapid, objective detection of respiratory syncytial virus (RSV) infections.

SmallCapVoice.com, Inc. announced today that a new audio interview with avVaa World Health Care Products (Pink Sheets:AVVH), is now available.

The Spectranetics Corporation (Nasdaq:SPNC) today announced the launch of the Turbo Elite® .035 product line extension.

TECHNE Corporation (Nasdaq: TECH)
announced today that the Company's s executive management will host a conference call beginning at 3:30 p.m. Central Time on September 19, 2013, to discuss its global strategic vision and to answer questions.



"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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