Vical Completes Target Enrollment in Its Phase 2 Therapeutic HSV-2 Vaccine Trial
- Category: Vaccines
- Published on Wednesday, 19 April 2017 17:23
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SAN DIEGO, CA, USA I April 19, 2017 I Vical Incorporated (Nasdaq:VICL) announced today that it has completed the target enrollment of 225 subjects in a Phase 2 trial of its therapeutic bivalent vaccine for herpes simplex virus type 2 (HSV-2), the leading cause of recurrent genital herpes.
The randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of the vaccine in healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection and is being conducted at 15 U.S. clinical sites. Subjects are evaluated for lesion recurrences over a 12-month period following a 4-dose vaccination series. The study is powered to show a reduction in annualized lesion recurrence rate, an endpoint which is clinically meaningful in this chronic disease setting because it provides information on the number of recurrences over time.
“A therapeutic vaccine is an important and promising new approach for reducing genital lesion recurrences because of its potential ability to boost immunity against HSV-2,” said Dr. John Kriesel, Associate Professor and infectious disease specialist at the University of Utah School of Medicine and one of the investigators in the Phase 2 trial. “Genital herpes afflicts one in six people in the United States and can be emotionally debilitating. A therapeutic vaccine would give patients a new treatment for this chronic disease.”
“We are pleased with the outstanding support we have received from our investigators and site staff, as the completion of the target enrollment of this Phase 2 trial represents an important milestone for this program,” said Dr. Mammen “Anza” Mammen, Vical’s Vice President, Clinical Vaccines. “We continue to follow these subjects and anticipate release of top-line efficacy results during the second quarter of 2018.”
HSV-2 is a sexually transmitted virus that causes a persistent infection that 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. There is no FDA approved vaccine for HSV-2. Vical’s investigational therapeutic bivalent vaccine encodes two full-length, HSV-2 antigens, glycoprotein D and VP11/12 tegument protein (also referred to as UL46) and is formulated with our patented adjuvant Vaxfectin®.
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. Additional information on Vical is available at www.vical.com.