Vical Provides Updates on CMV Vaccine Programs
SAN DIEGO, Jan. 11, 2012 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) today announced the online publication of a new article1 in The Lancet Infectious Diseases detailing results from the company's completed Phase 2 proof-of-concept trial of its TransVax™ therapeutic vaccine, which is designed to control cytomegalovirus (CMV) infection or reactivation in transplant recipients. Separately, the company is participating this week in a two-day public workshop jointly sponsored by multiple agencies within the U.S. Department of Health and Human Services (HHS), "The Development and Evaluation of Human Cytomegalovirus Vaccines," in connection with the company's CyMVectin™ prophylactic vaccine, which is designed to elicit protective immunity in young women before they become pregnant, thereby protecting the fetus from transmission of CMV during pregnancy.
CMV is a herpes virus that infects more than half of all adults in the United States by age 40, and is even more widespread in developing countries. While a healthy immune system typically protects an infected person from developing CMV disease, it rarely succeeds in eliminating the infection. Those whose immune systems are not fully functional are at high risk of CMV infection or reactivation, potentially leading to severe illness or death; those at greatest risk include transplant patients and infants born to mothers who first become infected during pregnancy. Vical is pursuing two different vaccine approaches for these distinct market segments.
TransVax™ Therapeutic CMV Vaccine Program
During the third quarter of 2011, Vical and Astellas Pharma Inc. entered into exclusive worldwide license agreements to develop and commercialize TransVax™. Astellas expects to initiate a pivotal, multinational Phase 3 trial of TransVax™ for hematopoietic stem cell transplant (HSCT) recipients, and a Phase 2 efficacy trial of TransVax™ for solid organ transplant (SOT) recipients, both in the first half of 2012.
In an editorial commentary2 accompanying the article in The Lancet Infectious Diseases, independent CMV expert Christoph Steininger, MD, of the Medical University of Vienna, said, "… Kharfan-Dabaja and colleagues describe a phase 2, placebo-controlled trial of a therapeutic cytomegalovirus DNA vaccine (TransVax™) for patients undergoing haemopoietic stem-cell transplantation. Occurrence and duration of episodes of cytomegalovirus viraemia were significantly reduced when cytomegalovirus-seropositive patients, who are at highest risk for cytomegalovirus disease, received up to four doses of the vaccine. The results of this study are exciting, particularly in view of the frustrating failures of previous trials."
TransVax™ is a bivalent DNA vaccine encoding the CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) antigens for induction of both cellular and humoral immune responses. TransVax™ is formulated with a proprietary poloxamer-based delivery system. TransVax™ has received orphan drug designation in the United States for HSCT and SOT recipients.
CyMVectin™ Prophylactic CMV Vaccine Program
In the CMV workshop, Vical is participating on two panels with other CMV vaccine developers, including Merck, Sanofi, GlaxoSmithKline and Novartis, addressing potential regulatory pathways for prophylactic CMV vaccine development, and specifically addressing potential Phase 3 endpoints for a prophylactic application. The workshop is jointly sponsored by the U.S. Food and Drug Administration (FDA) and its Center for Biologics Evaluation and Research (CBER), the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC), and the National Vaccine Program Office (NVPO).
To prevent infection in females of child-bearing potential, Vical is developing CyMVectin™, a prophylactic DNA vaccine encoding the pp65 and gB antigens. The CyMVectin™ vaccine is formulated with Vical's Vaxfectin® adjuvant in order to enhance antibody and T-cell responses. The FDA has allowed the company's Investigational New Drug (IND) application for a Phase 1 trial of the CyMVectin™ vaccine, and Vical is exploring collaborative opportunities for further development and commercialization.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.
The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768
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 statements about Vical's technologies, the TransVax™ and CyMVectin™ CMV vaccines, as well as the company's focus, collaborative partners, and independent and partnered product candidates. Risks and uncertainties include whether Vical or others will continue development of TransVax™, CyMVectin™ or any other product candidates; whether endpoints under discussion will be acceptable to the relevant regulatory agencies; whether Phase 2 results will be predictive of results in any future studies; whether Vical or its collaborative partners will seek or gain approval to market TransVax™, CyMVectin™ or any other product candidates; whether Vical or its collaborative partners will succeed in marketing 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.
1 Kharfan-Dabaja MA, Boeckh M, Wilck MB, et al. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2012; published online Jan 10. DOI:10.1016/S1473-3099(11)70344-9.
2 Steininger C. Cytomegalovirus vaccine: light on the horizon. Lancet Infect Dis 2012 ; published online Jan 10. DOI:10.1016/S1473-3099(11)70367-X.
CONTACT: Alan R. Engbring
Posted: January 2012