See feature article below: Vical Incorporated (NASDAQ: VICL)
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Report For: Vical Incorporated (NASDAQ: VICL)
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches.
SAN DIEGO, June 13, 2016 (GLOBE NEWSWIRE) — Vical Incorporated (VICL) announced today that the company will present clinical data on its completed HSV-2 Phase 1/2 trial at the American Society of Microbiology (ASM) Microbe/ICAAC 2016 conference (Boston, June 16 – 20).
Dr. Mammen P. “Anza” Mammen, M.D. Vical’s Vice President, Clinical Vaccines, will present in the conference’s clinical virology session on June 20, 2016 at approximately 10:30 am. Trial results, including safety and efficacy endpoints, will be presented in the oral late-breaker presentation. The slides presented by Dr. Mammen will be available on Vical’s website after the presentation.
Vical’s Therapeutic HSV-2 Vaccine: Current Status
The completed Phase 1/2 trial was a double-blind, placebo controlled study at seven investigational sites in the U.S. All enrolled subjects were required to be HSV-2 seropositive, as established using the University of Washington’s Western blot assay. In addition, these subjects were required to have a history of symptomatic genital herpes with 2 to 9 lesion recurrences per year; higher herpes shedding rates are observed in symptomatic compared to asymptomatic subjects6 and also permit the opportunity to explore potential reductions in lesions after vaccination.
The trial consisted of a dose escalation component to assess the safety of ¼ dose, ½ dose, and a full dose of vaccines in a small number of subjects prior to dosing additional subjects at the full dose. Regardless of dose, subjects were to receive the vaccine or a placebo on days 0, 28, and 56.
Subjects in the efficacy cohort performed daily swabbing to measure HSV shedding rates both before vaccination and again after vaccination. Importantly, sampling periods of 60 days for swab collections were designed for this study to generate robust shedding data to compare the pre-vaccination to the post-vaccination periods. Essentially the amount of viral shedding was measured for each subject at baseline (pre-vaccination) and then again after the intervention (completion of 3 vaccination series, the post-vaccination period).
With approximately 60 subjects per each vaccine group, the study was powered to show at least a 30% decrease in the shedding rate. The trial enrolled 165 subjects.
Source – Company Website / Press Release
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