On February 7, 2017 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, and the Providence Cancer Center reported the presentation of preclinical and early clinical data from two investigator-initiated Phase 1 clinical trials of GR-MD-02 used in combination with approved cancer immunotherapies (Filing, 8-K, Galectin Therapeutics, FEB 7, 2017, View Source [SID1234517663]). Data presented today at the 9th GTCBio Immunotherapeutics & Immunomonitoring Conference in San Diego, CA by Dr. William L. Redmond, Providence Cancer Center, has been posted.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Preclinical results in mouse models of multiple types of cancers show
ed important anti-tumor and increased survival effects of combining GR-MD-02 with different types of immune modulators, providing a compelling case for progressing studies into human patients with cancer" said William L. Redmond, Ph.D., Associate Member, Laboratory of Cancer Immunotherapy, and Director, Immune Monitoring Laboratory, Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR. "We are pleased that our translational medicine team is conducting two phase 1 clinical trials which were initiated under the direction of principal investigator Brendan D. Curti, M.D., Director of the Providence Biotherapy Program at Providence Cancer Center."

GR-MD-02 was combined with pembrolizumab (KEYTRUDA) in patients with advanced melanoma, and this study has been expanded to patients with oral/head and neck cancer (OHN) and non small cell lung cancer (NSCLC) (View Source). Six subjects with advanced melanoma have been enrolled in the lowest dose cohort (2 mg/kg) with no safety concerns related to GR-MD-02. To date, one partial response and one mixed response has been observed. Below is a chest CT scan of the patient with a partial response showing a marked reduction in tumor size at week 12 of therapy, after 3 doses of combined GR-MD-02 and pembrolizumab.

Baseline CT Scan
Week 12 Therapy CT Scan
LOGO
GR-MD-02 was also combined with ipilimumab (Yervoy) in patients with advanced melanoma (View Source). Seven subjects treated with the lowest two dose cohorts of GR-MD-02 (1 and 2 mg/kg) have been completed with no safety signals identified due to GR-MD-02. In these low dose initial cohorts, there were no notable changes in the peripheral immune signature. Due to changes in the standard of care for metastatic melanoma (i.e., approval of KEYTRUDA), recruitment has been slowed significantly.
"We are encouraged by these early safety results and look forward to further data on the safety and efficacy of GR-MD-02 used in combination with pembrolizumab (KEYTRUDA) in patients with metastatic melanoma, OHN, or NSCLC", said Dr. Curti. "While we cannot conclude from the one partial response in the pembrolizumab study that the response was related to GR-MD-02, it provides us with a clinically relevant signal to follow as GR-MD-02 doses are escalated. We hope to report additional data in early 2018 when we anticipate a decision on progressing to phase 2. This decision will be based on the response rate of the combination of pembrolizumab with GR-MD-02 as compared to historical response rates to pembrolizumab alone."

About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.