DALLAS, April 13, 2015 (GLOBE NEWSWIRE) -- Gradalis Inc., a late-stage biopharmaceutical company, today announced that Phase 2 data for its proprietary personalized immunotherapy, Vigil™ (previously named FANG), in the treatment of women with Stages III/IV ovarian cancer were presented in Chicago at the 2015 Annual Meeting of the Society of Gynecologic Oncology.
Dr. Jonathan Oh (Texas Oncology, P.A. Dallas, TX) presented data from a multicenter, randomized, open-label Phase 2 trial where women with Stages III/IV high-risk ovarian cancer, who had completed primary surgery and chemotherapy in clinical complete response were randomized 2:1 to Vigil™ immunotherapy or standard-of-care observation. Vigil™ therapy was prepared from each patient’s own tumor cells obtained at initial surgical debulking and was administered as a standard intradermal injection once a month for up to 12 doses. Patients were followed for safety and relapse-free survival (RFS).
In thirty-one randomized patients, all of whom had Stage IIIc or IV cancer, the Vigil™-treated patients (N=20) achieved a median RFS of 19.3 months versus 12.4 months in the control patients (N=11), p=.084. No adverse events greater than Grade 1/2 local injection-site irritation/induration were observed in the Vigil™-treated patients.
“These data demonstrate the potential of Gradalis’ innovative personalized immunotherapy, Vigil™, to improve tumor control in a setting where no other therapy is currently approved,” said Joseph M. Limber, President and Chief Executive Officer of Gradalis. The company announced this February the initiation and first patient tumor procured on a confirmatory randomized placebo controlled Phase 3 trial in this patient population.
The current Phase 3 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. Another clinical-stage program targets treatment of high-risk patients with relapsed Ewing’s sarcoma, and a Phase 1 program supports development in multiple other solid tumors.
Vigil™ 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, Vigil™ 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.
For more information about Gradalis, Inc. please visit www.gradalisinc.com.
Contact: Beth Kriegel Chief Financial Officer (214) 307-8203