Galectin Announces First Patient Dosed in Phase 1 Trial of GR-MD-02; Merck Announces FDA Acceptance of New Drug Application for Vorapaxar Print E-mail
By Staff and Wire Reports   
Wednesday, 24 July 2013 19:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 24, 2013.

Galectin Therapeutics (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient has been successfully dosed in a Phase 1 clinical trial of GR-MD-02. The first-in-man study will evaluate the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis.

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin proteins play a major role in diseases that involve scaring of organs such as cancer, and inflammatory and fibrotic disorders. The drug binds to galectin proteins and disrupts their function. Preclinical data has shown that GR-MD-02 has robust treatment effects in reversing fibrosis and cirrhosis.

"The successful first patient dosing in the clinical trial of GR-MD-02 is a critical milestone in Galectin's development program. There are currently no treatments for fatty liver disease with advanced fibrosis; this milestone takes us one step closer to bringing a first-in-class treatment to the millions of Americans suffering from this silent epidemic," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "We anticipate that enrollment of the first cohort of eight patients in the Phase 1 trial will be complete by late summer with initial safety and tolerability results available following the 70 day study period and analysis of the data."

The Phase 1 multi-center, partially-blinded clinical trial will be conducted in 24 patients with fatty liver disease and advanced fibrosis who will receive four weekly doses of GR-MD-02. The study, which includes a dose escalation design, will be conducted at six US centers with extensive experience in clinical trials in liver disease. This first patient dosing took place at Indiana University under the direction of the Principal Investigator Dr. Naga Chalasani, a world-renowned expert in NASH.

The trial is titled, "A Multi-Center, Partially Blinded, Maximum Tolerated Multiple Dose Escalation, Phase 1 Clinical Trial to Evaluate the Safety of GR-MD-02 in Subjects with Non-Alcoholic Steatohepatitis (NASH) with Advanced Hepatic Fibrosis." Trial design details can be found at http://clinicaltrials.gov/ct2/show/NCT01899859?term=gt-020&rank=1.

An estimated 9 to 15 million Americans, including children, are affected by fatty liver disease. Without an available therapeutic treatment, the only alternative for patients with fatty liver disease is a transplant but there are limited donors available and the procedure is costly.

Recently, Galectin submitted a Fast Track application to the FDA to help expedite its clinical development program of GR-MD-02 in fatty liver disease with advanced fibrosis. FDA grants Fast Track designation to help expedite review and approval of drugs in development that treat serious or life threatening diseases and fill an unmet medical need.

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Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, announced the New Drug Application (NDA) for its investigational anti-thrombotic medicine, vorapaxar, has been accepted for standard review by the U.S. FDA.

Merck is seeking FDA approval of vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack (TIA).



Also Wednesday:



Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
announcedtoday that it will provide a corporate update and report second quarter 2013 financial results before the NASDAQ Global Select Market opens on Thursday, August 1, 2013.

In that pursuit, a team consisting of Battelle, NxStage Medical (NASDAQ: NXTM), Inc. and Aethlon Medical (OTCQB: AEMD) has won a contract from the Defense Advanced Research Projects Agency, or DARPA, to develop an innovative, new medical device that may save the lives of soldiers -- and civilians as well -- by treating sepsis.

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, today announced that it will release its second quarter ended June 30, 2013, financial results on Wednesday, July 31, 2013.

Eli Lilly and Company (NYSE: LLY)
today announced financial results for the second quarter of 2013.

Michigan-based natural products developer Health Enhancement Products (OTCQB: HEPI) announced today that John B. Payne has agreed to join its board of directors.

INSCOR, Inc. (PINKSHEETS: IOGA)
announced today that it has entered into negotiations with the Republic of Ghana's National Mass Social Welfare Scheme (MSWS) http://www.mswsghana.org to insure the replacement of lost or stolen welfare cards issued to its members.

InterMune, Inc. (NASDAQ: ITMN)
today announced results from operations for the second quarter ended June 30, 2013, and recent business highlights.   

When LifeApps Media, Inc. (OTCQB: LFAP)
chose to join the fight against the obesity epidemic sweeping the nation, it did so armed with a source that understands the battle ahead.

Life Technologies Corporation (NASDAQ: LIFE)
today announces further expansion of its qPCR line of instruments with the introduction of two platforms: the QuantStudio™ 7 Flex Real-Time PCR and the QuantStudio™ 6 Flex Real-Time PCR systems.

The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ)
announced that trading of Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), a biopharmaceutical company dedicated to developing innovative small molecule treatments for cancer and inborn errors of metabolism, commenced on The NASDAQ Stock Market on July 24, 2013.

Nanosphere, Inc. (NASDAQ: NSPH)
, a leader in the development and commercialization of advanced molecular diagnostics systems, today announced that it will report its results for the second quarter of 2013 after the market closes on Tuesday, August 6, 2013.

In a newly released research update, Goldman Small Cap Research, a stock market research firm focused on the small cap and microcap sectors, notes in a recent article on its website how biotech firms such as Nuvilex Inc. (OTCQB: NVLX) can successfully reduce their risk profile as they reach pivotal inflection points in their growth and maturation.

Organovo Holdings, Inc. (NYSE MKT: ONVO)
, a biotechnology company focused on delivering breakthrough three-dimensional (3D) bioprinting technology, and Methuselah Foundation, a public charity incentivizing innovation in regenerative medicine, today announced that Methuselah Foundation has initiated a campaign in which it will fund research at major research institutions using Organovo's proprietary NovoGen Bioprinting technology.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report second quarter 2013 results on Tuesday, August 6, 2013.

Pharmacyclics, Inc. (Nasdaq: PCYC)
today announced that it will report financial results and recent developments for its second quarter ended June 30, 2013 after the NASDAQ Market closes on Wednesday, July 31, 2013.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR)
announced today that patient screening will commence in connection with Questcor's Phase 2 Study to explore the safety and tolerability of H.P. Acthar® Gel (repository corticotropin injection) in patients with Amyotrophic Lateral Sclerosis (ALS).

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III CLL11 study. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint showing that GA101 plus chlorambucil helped people live significantly longer without their disease worsening (progression-free survival; PFS) compared to Rituxan® (rituximab) plus chlorambucil.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
today reported second quarter 2013 financial results and accomplishments.

SK3 Group, Inc. (PINKSHEETS: SKTO)
announced today that it has engaged the International firm Rubicon Capital Advisors LLC to advise SK3 and its subsidiary, Medical Greens, Inc. on all matters concerning shareholder and investor awareness for a period of 6 months.

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
, announced today that a preclinical abstract on KLH-conjugate vaccine for Clostridium difficile infection ("C. diff") has been accepted for oral presentation at the 8th International Conference on the Molecular Biology and Pathogenesis of the Clostridia (ClostPath 8) to be held in Queensland, Australia October 22-26, 2013.

Warner Chilcott plc (Nasdaq:WCRX)
today announced its results for the quarter ended June 30, 2013.



"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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