|Galectin Therapeutics Inc (NASDAQ:GALT) Gains 40% On GR-MD-02’s Phase 1 Results|
|By William Kent|
|Wednesday, 07 January 2015 18:37|
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer had announced that final results from their Phase 1 trial showed that GR-MD-02 had an effect on a serum biomarker and liver stiffness that suggest a potential for therapeutic effect on fibrosis that warrants further exploration.
Galectin is leveraging extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The study secondarily examined exploratory biomarkers as well as a newer non-invasive liver stiffness measure.
Final Phase 1 data are included in a new corporate presentation which is available on the Company's website. Stephen A. Harrison, M.D., the lead investigator of the trial and Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston said that the final conclusion of the Phase 1 trial is that GR-MD-02 is safe and well tolerated after multiple doses.
GR-MD-02 administered to patients in three cohorts in doses up to 8 mg/kg for a total of four doses was found to be safe and well-tolerated. There were no serious adverse events or treatment-emergent adverse events attributed to the study drug. Mild (grade 1) adverse events possibly attributable to drug were identified in more patients receiving placebo (4 patients) than those receiving active drug (2 patients). The highest dose in the third cohort suggested a desired dose for testing in Phase 2 clinical trials. Patients in the third cohort were also evaluated for liver stiffness with FibroScan®, an ultrasound-based instrument approved by the U.S. Food and Drug Administration (FDA) for use in non-invasive liver diagnosis. Liver stiffness as measured by FibroScan® has been shown in multiple studies to correlate with the degree of liver fibrosis as assessed by liver biopsy.
Shares of the company soared as much as 40% to $4.50 on hefty volume.