Astellas and Vical Advance Toward Phase 3 Trial of TransVax(TM) CMV Vaccine Triggering $10 Million Milestone Payment to Vical
SAN DIEGO, Apr 2, 2012 (GlobeNewswire via COMTEX) -- Vical Incorporated today announced that Astellas Pharma Inc. and Vical have finalized the general design of a pivotal, multinational Phase 3 trial of TransVax(TM), the companies' therapeutic cytomegalovirus (CMV) vaccine for transplant recipients. This progress triggers a $10 million milestone payment to Vical. Based on guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the companies have confirmed that CMV disease will not be the primary endpoint in the Phase 3 trial.
The companies expect to initiate the Phase 3 trial of TransVax(TM) for hematopoietic stem cell transplant (HSCT) recipients in the second half of 2012, and initiate a Phase 2 efficacy trial of TransVax(TM) for solid organ transplant (SOT) recipients shortly thereafter. Specific endpoints and trial design concepts will be announced when the trials begin. Vical and Astellas entered into exclusive worldwide license agreements in 2011 to develop and commercialize TransVax(TM). Under the services and supply agreement, Vical will manufacture TransVax(TM) for Astellas through the remaining clinical development and commercial launch.
TransVax(TM) 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(TM) is formulated with a proprietary poloxamer-based delivery system. TransVax(TM) has received orphan drug designation in the United States for HSCT and SOT recipients.
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 against CMV disease, it rarely eliminates the infection. Those whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death. CMV affects 30% to 60% of patients undergoing transplant procedures, causing transplant rejection, serious illness and even death if untreated. Expensive and toxic antiviral drug therapy is used to control the disease, but does not eliminate the infection. There is no approved vaccine against CMV.
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 .
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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 the TransVax(TM) CMV vaccine and related clinical trials, as well as the company's focus, collaborative partners, and independent and partnered product candidates. Risks and uncertainties include whether the Phase 3 trial in HSCT recipients will begin in the second half of 2012, if at all; whether the Phase 2 trial in SOT recipients will begin shortly thereafter, if at all; whether either or both trials will achieve their respective endpoints; whether Vical or others will continue development of TransVax(TM) or any other product candidates; whether Vical will manufacture TransVax(TM) for Astellas through the remaining clinical development and commercial launch, if at all; whether Vical or its collaborative partners will seek or gain approval to market TransVax(TM) 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.
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SOURCE: Vical Incorporated
CONTACT: Alan R. Engbring