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Vical (VICL) Reports Phase I/II Data on Genital Herpes Vaccine

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Vical Incorporated presented data from a phase I/II study on its genital herpes vaccine at a meeting of the American Society for Microbiology. The randomized, double-blind, placebo controlled study evaluated the genital herpes vaccine candidate in symptomatic herpes simplex virus type 2 (HSV-2) infected patients.

The study evaluated two formulations of the vaccine – a monovalent (gD) vaccine and a bivalent (gD + UL46) vaccine.

Data from a nine-month analysis of the bivalent vaccine demonstrated a statistically significant reduction in the lesion rate, compared to baseline. The bivalent vaccine also revealed a favorable trend in the recurrence rate, time to first recurrence and the proportion of recurrence-free patients.

Vical said that it will evaluate the bivalent vaccine in a follow-on study to measure a clinically relevant endpoint. The company is currently in discussion with the FDA to determine the next step. A phase II study on the bivalent vaccine is expected to begin in the second half of 2016.

Meanwhile, the company reiterated its 2016 guidance for net cash burn of $8–$11 million.

Vical said that it is also working on developing its pipeline. The company expects to complete enrolment in a phase III study on ASP0113 in hematopoietic cell transplant recipients in the third quarter of 2016. It also expects to top-line data readout from the phase II study on ASP0113 in kidney transplant recipients in the third quarter of 2016. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus disease.

Vical currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).

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