GOG to initiate combination elesclomol-paclitaxel Phase 2 clinical trial for ovarian cancer

Nov 1 2010

Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that the Gynecologic Oncology Group (GOG) will initiate a Phase 2 clinical trial of elesclomol in combination with paclitaxel for the treatment of persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer. The GOG is a non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.

“There are few treatment options for women whose cancer has progressed after first and second line treatment with approved agents including platinum-based therapies”

Synta also announced that the National Cancer Institute (NCI) will provide financial support of up to approximately $300,000 for the trial through its Cancer Therapy Evaluation Program (CTEP).

"There are few treatment options for women whose cancer has progressed after first and second line treatment with approved agents including platinum-based therapies," said Bradley J. Monk, M.D., Department of Obstetrics and Gynecology, Creighton University School of Medicine at St. Joseph's Hospital and Medical Center and the principal investigator on the trial. "Based on the synergistic anti-tumor activity seen in a number of preclinical models as well as encouraging activity seen in an ovarian cancer patient in a Phase 1 study of elesclomol, we believe that the combination of elesclomol and paclitaxel holds promise in patients with low baseline levels of lactate dehydrogenase (LDH) in this difficult-to-treat form of ovarian cancer."

"Elesclomol in combination with paclitaxel-based chemotherapy has shown potential for clinical benefit in patients with low to normal LDH levels in three randomized clinical trials: Phase 2b and Phase 3 trials in metastatic melanoma and a Phase 2b trial in non-small cell lung cancer," said Vojo Vukovic, M.D., Ph.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. "By directly targeting cancer cell energy metabolism - which represents a novel mechanism, distinct from chemotherapy or kinase inhibition - and with the benefit of a predictive biomarker to help select the patients most likely to respond, elesclomol has the potential to be an exciting, new approach to treating ovarian cancer and other malignancies."