Vical Incorporated VICL announced disappointing top-line data from a phase I/II study on its investigational genital herpes vaccine. The ongoing randomized, double-blind, placebo controlled study is evaluating Vical’s genital herpes vaccine candidate for the potential reduction of viral shedding and genital herpes lesions in patients infected with herpes simplex virus type II (HSV-2).
The study is evaluating two formulations of the vaccine – a monovalent (gD) vaccine and a bivalent (gD + UL46) vaccine – both of which is formulated with Vical’s Vaxfectin adjuvant (formulated therapeutic vaccine for HSV-2). According to top-line data from the study, which compared the pre-vaccination measurements for each cohort to the measurements taken during the swabbing period in months 2 and 3 following the last vaccine dose, both the monovalent and bivalent vaccines failed to meet the primary endpoint. We expect investors to react negatively to the news.
Meanwhile, Vical said that it will follow up on all patients in the study for safety for 12 months and efficacy for 9 months after they receive their final vaccine dose. The company will determine the future steps related to this program based on efficacy data collected during the 9-month period following the patients’ receipt of the final dose.
Meanwhile, Vical is working on developing its pipeline. Currently, the company has four candidates (independent as well as partnered) in the field of infectious diseases. Vical stated that it intends to focus on the development of its cytomegalovirus (CMV) vaccine (ASP0113) in partnership with Astellas Pharma, Inc. ALPMY. Meanwhile, patient enrolment in the phase II study on ASP0113 for prevention of CMV infection in kidney transplant recipients is complete. Data should be out by the second half of 2016. The phase III pivotal study on the candidate in hematopoietic stem cell transplant recipients in ongoing with patient enrolment expected to be complete by 2015 end.
Vical carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD and Acorda Therapeutics, Inc. ACOR. While Gilead carries a Zacks Rank #1 (Strong Buy), Acorda holds a Zacks Rank #2 (Buy).
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