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Galectin's GR-MD-02 Positive in Phase Ib Study With Keytruda

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Shares of Galectin Therapeutics, Inc. (GALT - Free Report) rallied 14.5% following the company’s release of positive preliminary results from a cohort 3 of a phase Ib study on its pipeline candidate GR-MD-02 in combination with Merck’s (MRK - Free Report) Keytruda. The candidate is currently being evaluated for the treatment of metastatic melanoma in patients whose disease progressed during or after receiving Keytruda as a monotherapy.

So far this year, shares of Galectin Therapeutics have skyrocketed 107.5% compared with the industry’s increase of 4%.

GR-MD-02 is a carbohydrate-based drug candidate inhibiting the galectin-3 protein, directly involved in multiple fatty liver disease plus fibrotic and other malignant diseases.

The phase Ib study is being conducted by the Providence Cancer Institute under principal investigator Brendan D. Curti, M.D., director, Providence Melanoma Program. The objective of the study is to develop a safe dose of GR-MD-02 and measure the response rate in combination with Keytruda. The study demonstrated encouraging results in objective response rate (ORR) and the disease control rate (DCR) for patients with metastatic melanoma.

The evaluation observed the ORR to be 50% in (n=7/14) patients with significant reduction in frequency of suppressive myeloid-derived suppressor cells while the DCR was 64% (n=9/14). The published ORR for Keytruda as a monotherapy in advanced melanoma ranges between 21% and 39%. Moreover, the combination therapy was well tolerated and it delivered a fewer adverse side effects compared with Keytruda alone.

Additionally, the study enrolled 14 patients with metastatic melanoma of which, six patients were diagnosed with head and neck cancer. The observed ORR and DCR were 33% and 67%, respectively, in head and neck cancer. Galectin Therapeutics will continue to collaborate with the Providence Cancer Institute to determine the prospects of GR-MD-02 in immunotherapy combination study.

Notably, Keytruda is the first anti-PD-1 therapy to gain an FDA approval and is now already approved across eight different tumor types in the United States. The drug is continuously growing and expanding into new indications and markets globally.

Zacks Rank & Stocks to Consider

Galectin Therapeutics currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the same sector are Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and BioSpecifics Technologies Corp. , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Pacira’s earnings estimates have moved 86.2% north for 2018 and 9.9% for 2019 over the past 60 days. The stock has rallied 13.9% year to date.

BioSpecifics’ earnings estimates have been revised 9.1% upward for 2018 and 11.7% for 2019 over the past 60 days. The stock has surged 33.3% so far this year.

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