Galectin Therapeutics, the Cancer Centre at the Cliniques universitaires Saint-Luc and the Ludwig Institute for Cancer Research (LICR) announced today that they will initiate a Phase 1/2 safety and efficacy trial testing a novel treatment combination in patients with advanced metastatic melanoma. The Belgian Federal Agency of Medicine and Health Products (FAMHP) granted approval to evaluate Galectin Therapeutics' carbohydrate-based galectin receptor inhibitor, GM-CT-01, together with an LICR peptide vaccine. The trial will enroll up to 46 patients from four clinical centers in Belgium and Luxembourg.
"This trial marks Galectin Therapeutics entry into the clinic with one of our lead programs and represents a substantial opportunity for us to learn about the broad immunotherapy potential for inhibiting galectin proteins which are over expressed by nearly all tumors," commented Peter G. Traber, M.D., President, Chief Executive Officer and Chief Medical Officer, Galectin Therapeutics.
"Preclinical studies have shown that GM-CT-01 enhances the ability of tumor-infiltrating T-lymphocytes to kill cells. Therefore, it is our hope that combining GM-CT-01 with an anti-cancer vaccine will induce a more efficient immune response that will aid in the shrinkage of metastatic tumors in patients with advanced metastatic melanoma," said Dr. Pierre van der Bruggen of LICR.
All patients will receive either MAGE-3.A1 or NA17.A2 injections at three-week intervals throughout the study and GM-CT-01 intravenously every three days, beginning after the third dose of the peptide vaccine. Patients with at least one superficial metastatic lesion will also receive GM-CT-01 at the site of the lesion.
Partial or complete response will serve as the efficacy endpoint for the trial. Patient enrollment will commence in early 2012, and initial safety data are expected by the end of 2012. The Cliniques universitaires Saint-Luc and LICR will fund the first stage of the trial, and the second stage will be funded through grants and/or Galectin Therapeutics funds.
Each of the two peptide vaccines has already been tested in advanced melanoma patients, either alone, with or without immunological adjuvant, or in other vaccine combinations. These vaccines were well tolerated and were associated with evidence of tumor regression in a minority of patients (5 to 20%). The GM-CT-01 compound has shown initial success in preclinical studies in improving the efficacy of T-lymphocytes in killing cells. GM-CT-01 has proven safe in 100 patients in previous human studies.
There are more than 100,000 individuals around the world diagnosed with melanoma each year. Current treatment options for patients with melanoma include chemotherapy, radiotherapy and immune modulating drugs, all of which have shown limited success in shrinking tumors and extending survival time in a subset of patients with advanced disease. This Phase 1/2 study will test a novel treatment concept: combining active vaccination and immunomodulatory agents to evaluate whether they are safe and have an impact in shrinking or eliminating metastatic melanoma tumors.
"We look forward to enrolling patients in this first-of-its-kind study to examine the impact of inhibiting tumor-secreted galectins for enhancing the ability of the immune system to attack cancer cells and have a therapeutic effect in patients with melanoma," said Prof. Jean-François Baurain of the Cancer Centre at the Cliniques universitaires Saint-Luc, the principal investigator on the trial.