Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of prime importance as far as pharma/biotech companies are concerned. These companies spend a significant amount in advancing their pipelines.
Galectin Therapeutics Inc.’s (GALT) pipeline looks promising with candidates like GR-MD-02 and GM-CT-01. Galectin Therapeutics recently received U.S. Food and Drug Administration (FDA)'s approval to proceed with its phase Ib study on GR-MD-02 in combination with Bristol-Myers Squibb Co.’s (BMY) Yervoy. The candidate is being evaluated for the treatment of metastatic melanoma. This study will be conducted at Providence Portland Medical Center in Portland, Ore.
An Investigational New Drug (IND) application for GR-MD-02 for the treatment of metastatic melanoma was filed in late Dec 2013.
The phase Ib study will evaluate escalating dosage of GR-MD-02 in conjunction with the standard therapeutic dose of Yervoy in patients with advanced melanoma. For these patients Yervoy would be considered as the standard of care. Enrollment is expected to commence in March this year.
This study will monitor toxicity and clinical response. Blood samples will also be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition.
As per information provided by the American Cancer Society, more than 76,000 new diagnoses and 9,100 deaths from melanoma occurred in the U.S. in 2012.
Other than metastatic melanoma, GR-MD-02 is also studied in phase I for the treatment of nonalcoholic steatohepatitis (NASH) with advanced fibrosis. NASH is also known as fatty liver disease. Galectin Therapeutics completed enrolling patients in the first cohort of the phase I study on GR-MD-02 on Jan 13, 2014. Galectin Therapeutics might start a phase II study in late 2014 or early 2015 based on phase I study results and expects phase II top-line data in the first half of 2016 depending on the design of the study.
Another candidate in the company’s pipeline, GM-CT-01, is currently in phase I/II for the treatment of metastatic melanoma skin cancer. GM-CT-01 is studied as a combination therapy with a tumor vaccine in patients with advanced melanoma.
Galectin Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked players in the pharma industry include Salix Pharmaceuticals Ltd. (SLXP) and Lannett Company, Inc. (LCI). Salix carries a Zacks Rank #1 (Strong Buy) while Lannett Co. carries a Zacks Rank #2 (Buy).
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