Genocea Reports Positive Top-Line 12-Month Data On HSV-2 Immunotherapy GEN-003

(RTTNews) - Genocea Biosciences Inc. (GNCA) announced positive top-line 12-month follow-up data from a Phase 1/2a study of GEN-003, the Company's immunotherapy candidate against herpes simplex virus type 2 or HSV-2.

At 12 months after the final dose, in an analysis of an exploratory endpoint, the mean reduction in genital lesion rate was 42 percent below baseline for the best-performing 30 microgram dose group, indicating that GEN-003 may continue to provide a durable effect on genital lesions beyond the six months previously reported.

The company said GEN-003 remained safe and well tolerated. Genocea intends to explore additional dose combinations in its upcoming Phase 2 dose optimization study, which may identify a dose which further improves the magnitude or durability of effect of GEN-003.

Final analysis of results at 6 months after dosing showed that the 30 microgram dose group decreased the genital lesion rate by 65 percent, and the viral shedding rate by 40 percent, both versus baseline. At 12 months, the mean viral shedding rate reverted to baseline levels for all dose groups. Both antibody and T-cell responses to GEN-003 remain elevated over baseline at 12 months.

The company said that the full data from this trial has been accepted for oral presentation at a major infectious disease medical meeting in October 2014.

The Phase 1/2a clinical trial was a double-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of GEN-003. The study enrolled 143 volunteers with a history of moderate-to-severe recurrent HSV-2 infection at seven clinics in the United States.

Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide. In the United States roughly 16 percent of the adult population, or 40 million people, are infected.