Dallas, Texas 07/21/2014 (FINANCIALSTRENDS) – Genocea Biosciences Inc. (NASDAQ:GNCA) today announced to commence a Phase II dose optimization study for its immunotherapy candidate GEN-003 which is indicated for the treatment of HSV-2 (herpes simplex-type 2). The management believes that there is significant medical need for an effective immunotherapy for HSV-2. The Company’s market research revealed that both physicians and patients would welcome a new treatment like GEN-003 with enhanced convenience of dosing, sustained duration of protection and efficacy similar to oral antivirals. This dose optimization trial will compare the best dose of GEN-003 from the Company’s Phase I/IIa clinical trial to other combinations of protein and adjuvant to estimate optimal dose for future trials.
About Phase II Trial
Chief Medical Officer of Genocea Biosciences Inc. (NASDAQ:GNCA), Dr. Seth Hetherington expressed that the Phase II trial builds on Phase I/IIa clinical trial whereby the company’s therapeutic vaccine demonstrated anti-viral effect. The Phase II study will enroll approximately 300 subjects from 17 sites across the U.S. In this placebo-control trial, all subjects will receive placebo or three doses of GEN-003 at 21-day intervals. The primary endpoint is the change in viral shedding rate as compared to baseline. The study will also assess the impact on a percentage of days with genital herpes lesions as reported by the subject. Patients receiving GEN-003 will be followed for 12 months following the last dose.
Genocea Biosciences Inc. (NASDAQ:GNCA) is a development stage biopharmaceutical company engaged in the development of T cell-enable immunotherapies and vaccines. The company utilizes its proprietary technology platform ATLAS™ to identify the targets to enable the rapid development of medicines that can trigger protective immune responses. The Company’s pipeline portfolio includes GEN-003 for HSV-2 therapy and GEN-004 for pneumococcus infections. The early stage programs of the company include testing of candidates for potential therapy of malaria, HSV-2 prophylaxis, chlamydia and cancer immunotherapy.