Our data show that GR-MD-02 has a powerful therapeutic effect on liver fibrosis as shown in several relevant animal models. Therefore, we chose GR-MD-02 as the lead candidate in a development program targeted initially at fibrotic liver disease associated with fatty liver disease. Development programs in other liver diseases, lung fibrosis, kidney fibrosis, or cardiovascular fibrosis are potential programs that may be initiated in the future.
Based on promising preclinical data with GR-MD-02, Galectin Therapeutics is pursuing initial indications for the drug in patients with NASH (fatty liver disease) with advanced fibrosis and cirrhosis. An investigational new drug (IND) application was submitted to the FDA for GR-MD-02 (January 2013) and subsequently we received notification from the FDA to proceed with a Phase 1 clinical trial (March 2013). GR-MD-02 also received Fast Track designation from the FDA for the Company’s program in NASH with advanced fibrosis (August 2013).
To learn more about our fibrosis development program, click here.
Learn more about fibrosis.
Based on studies in animal models, Galectin Therapeutics is exploring its galectin inhibitors in combination immunotherapy clinical trials. The initial cancer indication is advanced melanoma, the most deadly form of skin cancer. The American Cancer Society estimates that there were over 68,000 new diagnoses and 8,100 deaths from melanoma in the United States in 2011. Metastatic melanoma has a poor prognosis with less than 5% of patients surviving five years from the manifestation of visceral organ involvement.
Immunotherapy has been studied for decades to treat melanoma and the only FDA-approved immunotherapeutic agent for metastatic melanoma was interleukin-2 until 2011. There have been recent significant advances in the treatment of melanoma. The FDA approved the use of ipilimumab, an anti-CTLA4 monoclonal antibody, for first or second-line treatment of metastatic melanoma in March 2011. Since then additional immunotherapy agents have been approved. While these therapies are a major advance in melanoma therapy, there is still a need for improved therapy in patients with widespread melanoma.
Based on this basic research, the Providence Portland Medical Center filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) on December 27, 2013 to study GR-MD-02 in combination with Yervoy® (ipilimumab) in a Phase 1B study of patients with metastatic melanoma. The application was prompted by findings from a preclinical study led by tumor immunology expert William L. Redmond, Ph.D., of the Providence Portland Medical Center’s Earle A. Chiles Research Institute (EACRI). The preclinical study found that GR-MD-02 increased tumor shrinkage and enhanced survival in immune competent mice with prostate and breast cancers when combined with one of the immune checkpoint inhibitors, anti-CTLA-4 or anti-PD-1. These findings suggest a role for GR-MD-02 in cancer immunotherapy.
The Providence Portland Medical Center has initiated and is funding the following investigator initiated clinical trials:
Phase 1b Clinical Trial
• Title: Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma • Sponsor: Providence Health & Services
• Collaborators: Providence Cancer Center, Earle A. Chiles Research Institute; Galectin Therapeutics Inc.
• Status: Completed 2 dose cohorts; Enrolling cohort 3
• More information on trial design can be found at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02117362?term=GR-MD-02&rank=1
Phase 1b Clinical Trial
• Title: Galectin Inhibitor (GR-MD-02) and Pembrolizumab in Patients With Metastatic Melanoma
• Sponsor: Providence Health & Services
• Collaborators: Providence Cancer Center, Earle A. Chiles Research Institute; Galectin Therapeutics Inc. • Status: IND submitted; pending enrollment
Learn more about the science of cancer immunotherapy.
Galectin Therapeutics is conducting an exploratory Phase 2a clinical trial of GR-MD-02 in patients with moderate to severe plaque psoriasis based on the improvement of psoriasis seen in a patient in the GT-020 Phase 1 clinical trial. More information can be found regarding the rationale for this trial in a CEO Perspective and the design of the trial can be found at clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02407041?term=GR-MD-02&rank=5