• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

First Ad35-Based HIV-1 Vaccine Enters Phase I Clinical Trial at the NIH

Posted on: Thursday, 21 June 2007, 09:03 CDT

GenVec, Inc. (Nasdaq:GNVC), announced today that the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has begun a Phase I clinical trial to test a novel vaccine known as Ad35HIV-EnvA to prevent HIV-1 infection. This adenovector-based vaccine was developed under a collaborative research and development agreement (CRADA) between GenVec and the VRC.

The two-part Phase I clinical study is designed to evaluate the safety, tolerability and immunogenicity of the Ad35-EnvA vaccine in comparison to and in combination with the Ad5-EnvA vaccine in prime-boost schedules. The first part of the study, a dose-escalation evaluation, will enroll 15 healthy adult volunteers. Three groups of five subjects each will receive one intramuscular injection of the vaccine at three different doses. Following vaccination of each dose group, an internal safety review will be conducted. The second phase of the study is designed to test prime-boost combinations of Ad5- and Ad35-based vaccines.

"We are very excited to have this novel Ad35HIV-EnvA vaccine enter clinical trials at the VRC, one of the world's leading global HIV vaccine research groups," stated C. Richter King, Ph.D., GenVec's Senior Vice President of Research. "Since there is no known correlate of protection yet, evaluation of different technologies and delivery approaches is key to development of a successful HIV vaccine. The Ad35 platform was developed to address a potential concern that current Ad5-based vaccines have reduced immunogenicity in certain parts of the world due to potential pre-existing immunity to the Ad5 vector. This technology also provides GenVec with a proprietary approach to both the prime and boost components of the vaccine. Alternate adenovector serotypes such as Ad35 are one of many innovative technology approaches that GenVec has at its disposal to generate safe and effective vaccines," added Dr. King.

GenVec constructed the Ad35 vector in collaboration with the VRC and produced and tested the vector using the company's proprietary 293-ORF6 cell line under an existing sub-contract being managed and administered by SAIC-Frederick, Inc. Through its collaboration with the VRC, GenVec is exploring vaccination strategies that enhance immune responses to HIV based on the company's proprietary adenovector technologies.

About GenVec

GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of the company's product candidates uses patent-protected technology to deliver genes that produce beneficial proteins. GenVec's lead product, TNFerade™ is currently in a pivotal Phase II/III study (PACT) in locally advanced pancreatic cancer; Phase II studies are in progress in rectal cancer and melanoma; and Phase I/II studies are in progress in head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and seasonal and pandemic flu. Additional information about GenVec is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

Source: Business Wire

More News in this Category