|Galectin Announces First Patient Dosed in Phase 1 Trial of GR-MD-02; Targeted Medical Pharma Completes Middle East Distribution Agreement|
|By Mary Davila|
|Thursday, 17 April 2014 19:12|
Galectin Therapeutics (Nasdaq: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis has been successfully dosed with 4 mg/kg, which is double the dose given in cohort 1. Cohort 2, as with all phases of the clinical trial, was initiated in full compliance with the rules, regulations, and specific conditions set forth by the U.S. Food and Drug Administration (FDA) for this Phase 1 clinical trial. The second cohort follows highly successful results from the first cohort showing that 2 mg/kg was safe and very well tolerated, and that GR-MD-02 treatment resulted in significant improvement in multiple biomarkers of fibrosis and liver inflammation in patients with NASH with advanced fibrosis (see full results: http://galectintherapeutics.com/wp-content/uploads/2014/03/20140401GT020FirstCohortFINAL.pdf). The remaining patients in cohort 2 are expected to be enrolled over the next few weeks and we anticipate reporting the results of cohort 2 around the end of July.
"We were extremely pleased with the results of the first cohort, which demonstrated significant biomarker effects on fibrosis and inflammation in all the patients treated with GR-MD-02, coupled with good safety and tolerability," said Dr. Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "These positive results have propelled the enrollment of the second cohort with strong participation across our clinical trial sites. We anticipate the cohort 2 results will further support the use of GR-MD-02 in patients with NASH and advanced fibrosis, with the goal of reversing fibrosis and preventing complications of cirrhosis and liver transplantation."
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. In 2013, Galectin Therapeutics received Fast Track designation from the FDA for this clinical development program. 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.
Targeted Medical Pharma (OTCQB: TRGM), today announced the completion of an agreement between Analytical Testing Laboratories (ATL), a Lebanon based company that specializes in drug testing services and inborn errors of metabolism, for the exclusive distribution of the company’s amino acid based products to physicians and pharmacies throughout the Middle East.
The Agreement provides ATL with a limited exclusive license for the marketing and sales of certain products in twenty countries in the region. The Agreement includes a licensing fee, an annual minimum product purchase order and certain performance benchmarks which include meeting product registration and regulatory approvals as well as sales volume in a given country.
“We are excited to introduce our products to the Middle East, and look forward to working with ATL to rapidly scale the growth of their distribution in the region,” said William Shell, M.D. Chief Executive Officer and Chief Science Officer at Targeted Medical Pharma. “Expanding international operations is a pivotal part of our growth strategy and will provide additional capital for increased domestic sales.”
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Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced today that the first patient in cohort 2 of its Phase 1 clinical trial of GR-MD-02 in patients with NASH with advanced fibrosis has been successfully dosed with 4 mg/kg, which is double the dose given in cohort 1.
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