Galectin Therapeutics Inc.
GALT, the leading developer of therapeutics that target galectin
proteins to treat fibrosis and cancer, today announced that the first patient
has been dosed in cohort 1 of the Company's Phase 1B clinical trial evaluating
GR-MD-02 in combination with ipilimumab (Yervoy®) in patients with metastatic
melanoma. Providence Portland Medical Center's Earle A. Chiles Research
Institute (EACRI), a leader in immunotherapy research and translational
clinical trials in melanoma and other cancers, is conducting the study under
principal investigator Brendan D. Curti, M.D.
The study employs a 3+3 Phase 1 design with dose escalation of GR-MD-02, a
galectin inhibitor, in conjunction with the standard therapeutic dose of
ipilimumab in patients with advanced melanoma for whom ipilimumab would be
considered standard of care. Cohort 1, which seeks to enroll at least 3
patients (and up to 6 should there be drug associated adverse events), will
utilize 1 mg/kg of GR-MD-02 administered one hour before 3 mg/kg of ipilimumab
on days 1, 22, 43 and 65. Researchers will assess the effects of GR-MD-02 with
ipilimumab on melanoma response by inducing proliferation, activation and
memory function of CD8+ T cells. In addition to monitoring for toxicity and
clinical response, blood samples will be obtained to assess immunologic
measures relevant to galectin biology and ipilimumab T-cell check-point
inhibition. Tumor volume will be assessed by immune response RECIST criteria.
Additional trial details can be found at
http://www.clinicaltrials.gov/ct2/show/NCT02117362?term=NCT02117362&rank=1.
"Preclinical data have shown 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, Chief Executive Officer and Chief Medical Officer, Galectin
Therapeutics. "This Phase 1B clinical trial is a significant step in
investigating a new treatment option for advanced melanoma, the most deadly
form of skin cancer."
GR-MD-02 is Galectin Therapeutics' proprietary molecule that binds to and
inhibits galectin proteins, predominantly galectin-3. A preclinical study led
by tumor immunology expert William L. Redmond, Ph.D., of EACRI 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.
"Dr. Redmond's preclinical work suggests a role for GR-MD-02 in cancer
immunotherapy," said Dr. Curti, the trial's principal investigator, a medical
oncologist and director of the Providence Biotherapy Program at EACRI. "This
Phase 1B trial will build on this momentum and significantly contribute to our
scientific understanding of the effects of GR-MD-02 in combination with
ipilimumab in metastatic melanoma."
Galectin Therapeutics is providing its proprietary compound GR-MD-02 to EACRI
researchers, as well as supplying researchers with supporting analysis of the
pharmacokinetics of GR-MD-02 and the right to reference the Company's open IND
on GR-MD-02.
YERVOY ® is a registered trademark of Bristol-Myers Squibb Company.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in