DALLAS, Feb. 26, 2015 (GLOBE NEWSWIRE) -- Gradalis Inc., a late-stage biopharmaceutical company, today announced that it has initiated a Phase 3 registration trial for its proprietary autologous immunotherapy, Vigil™, in the treatment of women with stage III/IV ovarian cancer.
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study of Vigil™ in women with Stages III/IV high-grade ovarian cancer who have been treated with primary cytoreduction and 5 to 6 cycles of standard of care chemotherapy. These patients will have had Vigil™ prepared and stored from ovarian tumor cells obtained at the time of initial surgical debulking. There are currently no therapies approved for this setting.
This trial was rationalized based on randomized Phase 2 trial demonstrating efficacy, safety and immunological activity in the ovarian cancer patient population. Results presented at American Society of Gene and Cell Therapy confirmed that Vigil™ was well tolerated with only mild, local injection-site adverse events. Additionally, approximately 93% of patients demonstrated T-cell activation against their tumor antigen as early as 1 month after dosing of Vigil™.
"The initiation of this trial demonstrates Gradalis' significant advancement of our innovative, personalized immunotherapy which we believe has the potential to transform the way cancer is treated," said Joseph M. Limber, President and Chief Executive Officer of Gradalis.
This trial forms the basis for the Gradalis personalized immunotherapy program. The ovarian cancer program is the first of several development directions utilizing this personalized immunotherapy. Other programs are being assessed in the treatment of Ewing's sarcoma, colorectal cancer with liver metastases, selected patients with non-small cell lung cancer as well as other solid tumors.
VigilTM is a proprietary, personalized, immunotherapy platform developed by Gradalis. A patient's tumor cells are engineered to elicit a systemic T-cell directed immune response when administered to the patient in monthly intradermal injections. By utilizing the patient's own tumor as the antigen source, VigilTM is designed to elicit an immune response that is both specifically targeted and broadly relevant to each patient's unique tumor antigens.
Gradalis is a fully integrated biotechnology company based in Dallas, Texas that focuses on the development, manufacturing, and commercialization of novel proprietary personalized immunotherapies to treat cancer. Gradalis has its own GMP manufacturing facility in Carrolton, Texas. For more information about Gradalis, Inc. please visit www.gradalisinc.com.
CONTACT: Beth Kriegel Vice President, Finance & Chief Financial Officer (214) 307-8203Source:Gradalis, Inc.