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

Vical DNA Vaccine Technology Enters Phase 2 Clinical Trial for HIV

Posted on: Tuesday, 11 October 2005, 12:00 CDT

SAN DIEGO, Oct. 11 /PRNewswire-FirstCall/ -- Vical Incorporated announced today the initiation of a National Institutes of Health (NIH) sponsored Phase 2 clinical trial of a "prime-boost" vaccine approach against HIV. The trial involves priming an immune response with multiple doses of a plasmid DNA vaccine, based on Vical's proprietary DNA delivery technology, and boosting the response with a single dose of adenoviral vector vaccine given at a later date.

The vaccine was developed by scientists at the Dale and Betty Bumpers Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and was manufactured by Vical. The vaccine incorporates HIV genetic material from the three most globally important HIV subtypes, clades A, B and C, which are involved in about 85 percent of all HIV infections around the world. Vical has produced multiple DNA vaccines for the VRC against infectious disease targets including Ebola, severe acute respiratory syndrome (SARS), and West Nile virus, all of which have advanced into Phase 1 clinical trials over the past two years. The new HIV vaccine trial is the first VRC program to advance an HIV DNA vaccine into Phase 2 trials.

"VRC's progress in advancing to a Phase 2 trial with the prime-boost vaccine configuration is an important milestone for our technology," said Vijay B. Samant, Vical's President and Chief Executive Officer, "which is a key component of this combined approach. Through our collaboration with NIAID/NIH, we continue to expand the applications of our technology beyond our independent programs, particularly for challenging pathogens such as HIV, and emerging infectious diseases such as SARS, WNV and pandemic influenza."

The new Phase 2 trial vaccine incorporates parts of four HIV genes. Three of these vaccine components are modified versions of HIV genes called gag, pol and nef, synthetically made based on sequence from clade B, the subtype that predominates in Europe and North America. The fourth vaccine component is a modified version of the HIV gene named env. The env gene codes for a protein on the outer coat of the virus that allows it to recognize and attach to human cells. VRC scientists were the first to combine modified env from clades A and C, which are the most common in Africa and parts of Asia, with the modified env gene from clade B. The study is being performed by the HIV Vaccine Trials Network (HVTN), an NIAID-supported clinical trials group that evaluates and compares different HIV/AIDS vaccine candidates,

Earlier this month, preliminary results from a Phase 1 trial showed that the prime-boost approach was well tolerated and effective in producing potent cellular and antibody immune responses, including specific responses against each of the HIV subtypes. Data on eight healthy volunteers from the trial were presented September 7, 2005, at the AIDS Vaccine 2005 International Conference in Montreal, Canada. Cellular and antibody responses were several-fold higher in subjects vaccinated with a DNA prime followed by an adenoviral vector boost than in subjects who had received either DNA or adenoviral vector vaccine alone.

Vical announced in June 2005 the receipt of approximately $12.1 million in production orders for multiple clinical lots of DNA vaccines against HIV for the VRC under a subcontract managed by SAIC-Frederick, Inc. Production began in the second half of 2005, with shipments anticipated in 2005 and 2006 in support of future large Phase 2 studies.

About Vical

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 has retained all rights to its internally developed product candidates. 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 serve significant unmet medical needs. Additional information on Vical is available at http://www.vical.com/.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether VRC and HVTN will complete the trial as planned; whether large future Phase 2 trials, if any, are conducted; whether SAIC-Frederick will extend or terminate the agreements or any existing production orders; whether Vical will produce and deliver production lots as specified in the order; whether Vical will receive timely payment for delivery of such production lots; whether the HIV vaccine or any other product candidates will be shown to be safe and effective in clinical trials; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any 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.

Contacts: Investors: Media: Alan R. Engbring Susan Neath Vical Incorporated Atkins + Associates (858) 646-1127 (858) 527-3486 Website: http://www.vical.com/

Vical Incorporated

CONTACT: Investors, Alan R. Engbring of Vical Incorporated,+1-858-646-1127; or Media, Susan Neath of Atkins + Associates,+1-858-527-3486, for Vical Incorporated

Web site: http://www.vical.com/

Source: PRNewswire-FirstCall

More News in this Category