|Vanda Withdraws Its MAA For Fanaptum; GTx's Enobosarm Phase 2 Trial Published in The Lancet Oncology|
|By Staff and Wire Reports|
|Thursday, 14 March 2013 18:46|
Vanda Pharmaceuticals (NASDAQ: VNDA) announced it has withdrawn its Marketing Authorization Application (MAA) submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum™ (oral iloperidone tablets) for the treatment of adult patients with schizophrenia.
This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. The results of this study will not be available in the timeframe allowed in the Centralised Procedure.
Vanda intends to reassess its European regulatory strategy for Fanaptum™ once the results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) become available.
GTx, Inc. (Nasdaq: GTXI) announced the journal, The Lancet Oncology, has published online ahead of its April print edition (www.thelancet.com/journals/lanonc/onlinefirst) the results from GTx's randomized, double-blind, placebo-controlled Phase 2 clinical trial of enobosarm to assess its effects on muscle wasting and physical function in patients with cancer. Enobosarm (GTx-024) is a selective androgen receptor modulator (SARM), a new class of non-steroidal, tissue-specific anabolic agents that has the potential to increase muscle mass and improve physical function without the unwanted side effects on the prostate, skin or hair that are commonly associated with testosterone or non-selective, synthetic anabolic steroids. The lead author was Dr. Adrian S. Dobs, Professor of Medicine at the Division of Endocrinology and Metabolism, Johns Hopkins University School of Medicine in Baltimore, Maryland.
Cancer-induced muscle wasting begins early in the disease process, resulting in decreased physical function and other detrimental consequences, such as fatigue and weight loss, which can contribute to disability, reduced quality of life and shorter overall survival, compared with patients without muscle loss. There are no drugs approved for the prevention and treatment of muscle wasting in patients with cancer. The Phase 2 trial, which enrolled patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or breast cancer, demonstrated significant increases in lean body mass (primary endpoint) and physical function (one of the secondary endpoints) in patients treated with enobosarm 1 mg or 3 mg oral daily doses. Patients receiving placebo during the same period did not show significant increases in total lean body mass or in physical function.
The lead author, Dr. Adrian Dobs, an investigator in the Phase 2 trial, stated, “Muscle wasting is a common and devastating cancer-related symptom for which there are no effective therapies today. This is the first well controlled clinical trial to show that a selective anabolic agent, enobosarm, has the ability to not only increase muscle mass, but also improve physical function in a clinically relevant stair climb activity across a broad number of cancer types. After seeing the results of this Phase 2 clinical trial, I am looking forward to the results from the two Phase 3 clinical studies, POWER 1 and POWER 2, to confirm enobosarm's ability to prevent and treat muscle wasting in patients with advanced non-small cell lung cancer.”
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced its support of World Kidney Day 2013, a global awareness campaign led by the International Society of Nephrology (ISN) and the International Federation of Kidney Foundations.
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Columbia Laboratories, Inc. (Nasdaq: CBRX) today reported financial results for the three- and twelve-month periods ended December 31, 2012.
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Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that C. Randal Mills, Ph.D., President and Chief Executive Officer, is scheduled to present at the 2013 Canaccord Genuity Musculoskeletal Conference on Tuesday, March 19, 2013 at 9:30 a.m. ET (8:30 a.m. CT) in Chicago.
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Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has gained global development and commercialization rights to Ligand Pharmaceuticals’ (NASDAQ: LGND) Captisol-enabled®, propylene glycol-free (PG-free) melphalan.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today provided an update on recent progress with its clinical programs and reported financial results for the fourth quarter and year ended December 31, 2012.
Verenium Corporation (Nasdaq: VRNM), a leading industrial biotechnology company focused on the development and commercialization of high-performance enzymes, today announced certain preliminary financial results for its year ended December 31, 2012.