Vical (VICL) Commences Vaxfectin-Formulated, Bivalent, Therapeutic DNA Vaccine Phase 2 for HSV-2

September 26, 2016 6:31 AM EDT
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Vical Incorporated (Nasdaq: VICL) announced today the initiation of a Phase 2 trial of the company’s Vaxfectin™-formulated, bivalent, therapeutic DNA vaccine for herpes simplex virus type 2 (HSV-2) infection. The randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of the vaccine in approximately 225 healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection at up to 15 U.S. clinical sites.

“About one in six persons between the ages of 14 and 49 is infected with HSV-2. Given the substantial unmet need for HSV-2 treatments and the lack of new therapeutic breakthroughs for HSV-2 in decades, we look forward to further exploring the potential of Vical’s bivalent vaccine,” said Anna Wald, MD, MPH, Professor, Department of Medicine, Epidemiology and Laboratory Medicine at the University of Washington and Lead Investigator of the trial. “If we can demonstrate that this vaccine controls the frequency of HSV-2 recurrences, it may offer an exciting new treatment modality for physicians that would free patients from daily, antiviral drug usage.”

After a 4-dose vaccination series, subjects will be evaluated for recurrences over a 12-month period. Following extensive discussions with the FDA, Vical has selected recurrence rate as the primary endpoint for the study. “Based on discussions with our clinical experts, we have concluded that recurrence rate is one of the most clinically meaningful endpoints for patients with genital herpes,” said Mammen P. “Anza” Mammen, Jr., M.D., Vice President, Clinical Vaccines at Vical. “The endpoint of ‘annualized recurrence rate’ provides information on both the number and spacing of recurrences over time which we believe makes it more informative in this chronic disease setting than the endpoints of ‘time to first recurrence’ and ‘proportion of subjects recurrence-free’, both of which only measure the recurrence of singular events.”

The Phase 2 trial has been designed based on Phase 1/2 trial results presented at the 2016 American Society for Microbiology (ASM/ICAAC) Microbe Meeting in June that revealed a statistically significant reduction (-57%, p = 0.009) in lesion rate compared to baseline in the bivalent vaccine arm at 9 months, along with favorable trends in recurrence rate, time to first recurrence, and proportion of subjects who were recurrence-free. In addition, the bivalent vaccine produced a statistically significant increase in antigen-specific interferon gamma producing T cells. No serious adverse events, Grade 4 adverse events, or adverse events of special interest related to vaccinations were observed during the study period.

HSV-2 is a sexually transmitted virus which is the leading cause of recurrent genital herpes. HSV-2 infections are persistent and can result in painful genital lesions, as well as intermittent virus shedding placing sexual partners at risk of infection. Infection with HSV-2 also significantly increases the risk of acquiring the HIV-1 virus from HIV-infected sexual partners.

The Company’s cash burn projection remains unchanged for 2016 at between $8 million and $11 million, which includes the cash burn associated with the initiation of the HSV-2 Phase 2 clinical program.

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