Vical to Receive $1 Million Milestone Payment; Merck Initiates Naked DNA HIV Vaccine Trial|
SAN DIEGO--(BW HealthWire)--Jan.7, 2000--Vical Inc. (Nasdaq:VICL) today announced the initiation by Merck & Co. Inc. (NYSE:MRK) of a Phase I clinical trial testing a naked DNA vaccine to prevent infection with the human immunodeficiency virus (HIV) that causes the acquired immunodeficiency syndrome (AIDS).
Merck is developing the vaccine using Vical's patented naked DNA gene delivery technology. The trial, which began in late December, is designed to test the safety of the experimental vaccine and to evaluate immune responses in human volunteers. Vical will record the resulting $1 million milestone payment as license revenue in the fourth quarter of 1999.
Merck also holds a license to use Vical's naked DNA technology for a therapeutic vaccine against HIV, and for protective or therapeutic vaccines against several other infectious diseases. Preventive vaccines prime the body's immune system to respond to potential future infections by foreign organisms. Therapeutic vaccines trigger or boost the body's immune system to respond to existing infections by foreign organisms.
Vaccines are generally recognized as the most cost-effective approach for infectious disease health care. However, the technical limitations of conventional vaccine approaches have constrained the development of effective vaccines for many diseases. Our naked DNA vaccine technology may overcome two deficiencies of traditional preventive vaccine approaches, which are the inability to counteract the random changes in the strains of various infectious agents and the need for safe formulations that boost an antibody response or that cause sufficient killer T-cell responses, known as adjuvants. We believe our potential vaccine products should be simpler to manufacture than vaccines that are made using cumbersome and labor-intensive techniques involving difficult tissue culture procedures and live viruses.
"Our patented naked DNA vaccines may offer a new technology platform for severe infectious diseases," said Alain B. Schreiber, M.D., president and chief executive officer of Vical. "We are very pleased that Merck continues to make progress with our technology targeting HIV."
The UNAIDS Joint United Nations Programme on HIV/AIDS estimated in 1998 that 33.4 million people were living with HIV infection, 5.8 million people were newly infected with HIV, and 2.5 million people died from the disease. Infection with HIV is caused primarily by the exchange of bodily fluids through unprotected sex or through injection drug use with contaminated needles or syringes.
Untreated, the disease leads to gradual, long-term destruction of the immune system, leaving the patient vulnerable to infections and certain cancers. AIDS is a term used to describe the advanced disease stages resulting from HIV infection. In recent years in developed countries, the disease has been controlled with combination therapy, but it remains near-epidemic in underdeveloped areas. Over time, the HIV virus can also build a resistance to the various therapies, leaving long-term patients in a constant search for new treatment alternatives. To date, no effective vaccine has been developed, but a vaccine is considered the best hope for control and eventual eradication of the disease.
Vical Inc., The Naked DNA Company(TM), is focused on the development of pharmaceutical product candidates based on its patented gene delivery technology. A number of therapeutic and vaccine product candidates are currently under development for the prevention or treatment of cancer, infectious diseases and metabolic disorders by Vical and its collaborative partners, including Merck & Co., Pfizer Inc., Aventis Pasteur (formerly Pasteur Merieux Connaught), Aventis Pharma (formerly Rhone-Poulenc Rorer), Centocor Inc., Merial and Boston Scientific Corp.
Allovectin-7, which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with unresectable head and neck cancer. Leuvectin, which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with kidney cancer and prostate cancer. Vaxid, a naked DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing. In collaboration with the National Cancer Institute, a naked DNA vaccine to treat metastatic melanoma is in Phase I/II testing.
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements, including whether any product candidates will be shown to be safe and efficacious in clinical trials, the timing of clinical trials, whether Vical or Merck will seek or gain approval to market any product candidates, and additional risks set forth in the company's filings with the Securities and Exchange Commission. Actual results may differ materially from those projected. 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.
For news releases and other information about the company, visit the Vical Web site at www.vical.com.