SAN DIEGO, March 2, 2011 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL) announced today the receipt of Scientific Advice from the European Medicines Agency (EMA) recommending practical efficacy endpoints for a Phase 3 trial of the company's TransVax™ therapeutic cytomegalovirus (CMV) vaccine. Because the incidence of CMV disease is low and the target population—recipients of hematopoietic cell transplants—is small, the EMA agreed with the company's position that a CMV disease endpoint is not practical. The EMA also provided positive comments on important features of the proposed trial design and overall product development pathway.
Vical is currently evaluating plans for the pivotal Phase 3 trial with the U.S. Food and Drug Administration (FDA). The company will provide additional information about the trial upon completion of regulatory agency discussions, and expects to begin the planned Phase 3 trial in the second half of 2011.
Vical's TransVax™ Therapeutic CMV VaccineTo address the unmet need to protect transplant patients from CMV reactivation, Vical is developing TransVax™, a therapeutic DNA vaccine encoding the CMV glycoprotein B (gB) antigen and the CMV phosphoprotein 65 (pp65) antigen, and formulated with a poloxamer designed to enhance plasmid delivery and protein expression, resulting primarily in an increased cellular immune response. Vical's TransVax™ vaccine has U.S. orphan drug designation for transplant patients. In September 2010, Vical announced statistically significant immunogenicity and clinical efficacy results with no safety issues from a completed Phase 2 trial of the TransVax™ vaccine in patients undergoing hematopoietic stem cell transplants. About CMV 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 succeeds in eliminating the infection, and 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. Protein-based vaccines that predominantly result in antibody responses to CMV may have limited effectiveness in transplant patients. Live, attenuated vaccines can induce both antibody and cellular immune responses, but pose a potential safety concern, particularly for immunocompromised patients, of causing the disease they are intended to prevent.
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