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Vical’s Phase 1/2 Trial Data Presented at ASM 2016 Shows Bivalent Vaccine Imparts Reduction in Genital Herpes Lesions Durable to 9 Months
06/20/2016
Vical plans to advance the bivalent vaccine to a Phase 2 trial in 2016 and maintains current financial guidance for 2016
SAN DIEGO, June 20, 2016 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) presented data from the randomized, double-blind, placebo-controlled Phase 1/2 clinical trial of its therapeutic genital herpes vaccine in symptomatic herpes simplex virus type 2 (HSV-2) infected patients in an oral late-breaker presentation at the American Society for Microbiology (ASM/ICAAC) Microbe 2016 meeting held in Boston. The slides presented by Mammen P. "Anza" Mammen, Jr., M.D., Vical’s Vice President, Clinical Vaccines, will be accessible on Vical’s website.
The per protocol study analyses included 131 evaluable patients: 54 receiving the monovalent (gD) vaccine, 56 receiving the bivalent vaccine (gD + UL46) and 21 receiving placebo. Initial top line 3-month data announced in June 2015 showed that neither the monovalent nor the bivalent vaccine met the primary endpoint of viral shedding rate reduction from baseline. However, the bivalent vaccine achieved statistically significant reduction in a prospectively defined secondary endpoint of genital lesion rate at 3 months versus baseline (-49%, p = 0.031). In the 9-month analysis presented today, the statistically significant reduction in lesion rate compared to baseline for the bivalent vaccine was sustained (-57%, p = 0.009). Furthermore, at the 9-month time point, the bivalent vaccine showed a favorable trend in recurrence rate, time to first recurrence, and proportion of patients who are recurrence-free. Vical’s vaccines elicited significant increases in antigen-specific interferon gamma producing T cells, indicating biologic activity.
An independent Safety Monitoring Board reviewed all adverse events (AEs) and deemed the vaccines to be safe and tolerable in this trial. No serious adverse events, Grade 4 AEs, or AEs of special interest related to vaccinations were observed during the study period. Grade 3 AEs were reported in 13% of subjects, the most common of which were fatigue and injection site pain.
“There remains considerable unmet medical need in the treatment of genital herpes as there have been no new therapeutic breakthroughs in the past several decades,” said Dr. Peter Leone, Professor of Medicine, University of North Carolina and an external program advisor for Vical. “A therapeutic HSV-2 vaccine could represent a very attractive treatment option to reduce outbreaks in individuals who suffer chronically from this disease. The data generated to date with the bivalent HSV-2 vaccine indicate that it is not only immunogenic, but also provides evidence for reducing lesion rate, a clinically meaningful endpoint for patients and physicians. Therefore, the bivalent vaccine warrants further clinical investigation.”
“We have consulted with multiple experts involved in treating patients with genital herpes and conducting clinical trials,” said Vijay Samant, President and Chief Executive Officer. “Our advisors have encouraged us to evaluate the bivalent vaccine further in a follow-on study powered to measure a clinically-relevant endpoint. We have established a continuing dialogue with the FDA about potential next steps and are currently finalizing a clinical protocol based on those discussions. We plan to initiate a Phase 2 trial of the bivalent vaccine during the second half of 2016. Importantly, we expect to be able to execute this study using our current resources and under our operational plan, and maintain our guidance for net cash burn of between $8 million and $11 million during 2016.”
Mr. Samant continued, "We anticipate a number of additional clinical milestones this year. In our CMV program with Astellas, we expect that in the third quarter of 2016, enrollment will be completed in the Phase 3 registration trial in hematopoietic cell transplant recipients and that top line data should be available from the Phase 2 trial in kidney transplant recipients. In addition, we also anticipate completing the Phase 1 trial of our novel antifungal, VL-2397, by year end.”
About Vical
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.
Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include net cash use guidance, as well as anticipated developments in clinical programs, including the plans, timing of initiation, enrollment and announcement of data for clinical trials, and the potential benefits of Vical’s product candidates. Risks and uncertainties include whether Vical or others will continue development of Vical’s HSV-2 vaccine, ASP0113, VL-2397 or any other independent or collaborative programs; whether Vical will achieve levels of revenues and control expenses to meet its financial projections; whether Vical or its collaboration partners will be able to obtain regulatory allowances or guidance necessary to proceed with proposed clinical trials or implement anticipated clinical trial designs; whether on-going or planned clinical trials will be initiated or completed on the timelines Vical currently expects, whether any product candidates will be shown to be safe and efficacious in clinical trials; whether Vical will have access to sufficient capital to fund its planned development activities; whether Vical will seek or gain approval to market any product candidates; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
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