Vanda Withdraws Its MAA For Fanaptum; GTx's Enobosarm Phase 2 Trial Published in The Lancet Oncology Print E-mail
By Staff and Wire Reports   
Thursday, 14 March 2013 18:46
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 14, 2013.

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announced it has withdrawn its Marketing Authorization Application (MAA) submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum™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.


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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.”



Also Thursday:



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.

A handful of early investors are fighting an uphill battle after investing in shares of AntriaBio (OTCBB: ANTB), which recently swooped in to snag an intriguing lead diabetes product, AB101, after a private firm had already invested more than $100 million into the formulation, manufacturing and intellectual property development of the injectable once-a-week basal insulin solution for diabetics who are otherwise forced to take shots on a daily basis.

ArQule, Inc. (NASDAQ: ARQL)
today announced its financial results for the year and for the fourth quarter ended December 31, 2012.

Arrowhead Research Corporation (NASDAQ: ARWR)
, a targeted therapeutics company, today announced that a study of its RNAi-based candidate ARC-520 in a chimpanzee chronically infected with the human hepatitis B virus (HBV) supports findings from rodent models indicating that it can knock down HBV DNA and key viral antigens.

Assisted Living Concepts, Inc. (NYSE: ALC)
reported a net loss of $2.6 million in the fourth quarter of 2012 as compared to net income of $7.3 million in the fourth quarter of 2011.

BioClinica®, Inc., (NASDAQ: BIOC)
, a global provider of clinical trial management services, announced today that JLL Partners and Ampersand Capital Partners, two leading middle market private equity firms, have completed their acquisition of BioClinica and CoreLab Partners and have combined the two companies under the name BioClinica.

Bioheart, Inc. (OTCQB: BHRT)
is pleased to announce the appointment of Kristin C. Comella to the Board of Directors.

Cadence Pharmaceuticals, Inc. (NASDAQ: CADX)
, a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, announced today the appointment of Stephen L. Newman, M.D., to the company's board of directors.

Cardium Therapeutics (NYSE MKT: CXM)
today announced that it has received ISO 13485:2003 certification for its Excellagen® advanced wound care product by BSI, one of the world's leading certification bodies.

Cellular Biomedicine Group Inc. (OTCQB:CBMG)
today announced the appointment of Dr. Jianping Dai to the Board of Directors.

Columbia Laboratories, Inc. (Nasdaq: CBRX)
today reported financial results for the three- and twelve-month periods ended December 31, 2012.

Covidien plc (NYSE: COV)
will report second-quarter results on April 26, 2013, before trading begins.

GenSpera, Inc. (OTCBB:GNSZ)
announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted Orphan Drug Designation to its lead candidate, G-202, for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX)
today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the upcoming 25th Annual ROTH Conference, to be held March 17th -20th in Dana Point, California.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announces the signing of global license and supply agreements with Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) for the development and commercialization of Ligand’s Captisol-enabled®, propylene glycol-free (PG-free) melphalan.

Mauna Kea Technologies (NYSE Euronext: MKEA)
, leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, reported a new study showing that a Cellvizio optical biopsy can overcome the limitations of standard tissue biopsies in accurately diagnosing cancerous stomach tumors.

MiMedx Group, Inc. (OTC: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it will present at the Canaccord Genuity Musculoskeletal Conference in Chicago.  Parker H. "Pete" Petit, Chairman and CEO, William C. Taylor, President and COO, and Michael J. Senken, Chief Financial Officer, are scheduled to present on March 19th at 3:20 p.m. CDT/4:20 p.m. EDT at the Westin Michigan Avenue.

Nuvilex, Inc. (OTCQB: NVLX)
, an international biotechnology and clinical stage provider of natural products and cell and gene therapy solutions for the treatment of diseases, has established a subsidiary in the Medical Marijuana industry.

Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY)
("Oncolytics" or the "Company") today announced its financial results and operational highlights for the  year ended December 31, 2012.

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.

OvaScienceSM, (OTC: OVSC)
, a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today announced that Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, will present at the 25th Annual ROTH Conference on Tuesday, March 19 at 8:30 a.m. at The Ritz Carlton in Dana Point, Calif.

PAREXEL International Corporation (Nasdaq: PRXL)
today provided an update and announced the next steps with regard to the Company's share repurchase program.

Rapid Fire Marketing (OTC Pink: RFMK)
, a leading maker of vaporizers as well as the only publicly-traded company for vaporizers, announced today that the Company has updated its strategy for 2013 to reflect changes in demand in the vaporizer marketplace.

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.



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