Galectin Therapeutics Inc., a pharmaceutical company focused on developing treatment options for patients with life-threatening fibrosis or cancer diagnoses, recently announced its first Phase 1 human-trial cohort, testing Galectin protein inhibitor GR-MD-02 combined with the standard drug ipilimumab in patients with metastatic melanoma.
According to a recent company press release, the study, conducted by Dr. Brendan D. Curti, medical oncologist and director of the Providence Biotherapy Program at Earle A. Chiles Research Institute (EACRI), expects to determine the effectiveness of treating the disease using Galectin’s lead product in a combination therapy, as GR-MD-02 is believed to have a role in engaging cancer immunotherapy, according to Curti, who is the lead investigator of the trial.
These expectations are based on a preclinical study led by EACRI researcher Dr. William L. Redmond, who found that GR-MD-02 increased tumor reduction and improved survival in immune-competent mice suffering from prostate and breast cancer when combined with other inhibitors like anti-CTLA-4 or anti-PD-1.
Company researchers believe “that GR-MD-02 holds immense potential for increasing the effectiveness of other therapies, and may be an important approach in enhancing cancer immunotherapy,” said Dr. Peter G. Traber, President, CEO and Chief Medical Officer of Galectin, adding that this new phase of tests may constitute a “significant step in investigating a new treatment option for advanced melanoma, the most deadly form of skin cancer.”
Starting with one patient, but expecting to test three (and up to as many as six, if the drug reveals to have adverse effects), the study will consist of the administration of a 1 mg of GR-MD-02 one hour before the use of 3 mg of ipilimumab on days 1, 22, 43, and 65 of the trial. The researchers will seek to determine the effects of this combined administration on melanoma response. Dr. Curti’s team will also try to monitor toxicity and clinical response and to determine which immunologic measures could be relevant to trigger an immune system response.
The natural response of the immune system to infections is being used as a model to test therapies. Conversely, the lack of that response when it comes to cancer has led researchers to look to immunotherapy as a key point in cancer treatment.