SAN DIEGO--(BUSINESS WIRE)--June 9, 1997--Vical Incorporated (Nasdaq:VICL) announced today the
initiation of a Phase I/II clinical trial with Leuvectin, a potential cancer treatment, in approximately 18 prostate
cancer patients. The trial will be conducted at UCLA's Jonsson Cancer Center under the direction of Arie
Belldegrun, M.D., chief of genitourinary oncology at the UCLA School of Medicine, and Robert Figlin, M.D.,
director of clinical research at the Jonsson Cancer Center and medical director of genitourinary oncology
programs at the UCLA Medical Center.
Patients enrolled in the trial will receive two doses of Leuvectin followed after several weeks by either surgical
removal of the prostate gland (for patients with organ-confined disease) or prostate biopsy (for patients who
have suffered a recurrence of the disease after radiation therapy). The trial is intended to study the safety and
efficacy of Leuvectin as a potential therapy to destroy residual tumor cells and to prevent the recurrence of
prostate cancer.
Alain B. Schreiber, M.D., Vical's president and CEO, said, ``Using a DNA-based immunotherapeutic agent
such as Leuvectin in an adjuvant setting is a new approach for Vical. Because PSA (prostate- specific antigen)
testing offers a simple, accurate method to check for tumor recurrence, and because IL-2 protein therapy has
been shown to provide some benefit for prostate cancer patients, this disease is a logical choice for a Leuvectin
trial. We look forward to working with some of the leading oncologists in the genitourinary field as we explore
the potential for Leuvectin in these patient populations. The large number of prostate cancer cases and the high
mortality associated with advanced disease suggest a need for such novel treatment options.''
Leuvectin is a DNA-based product candidate currently being studied in melanoma, renal cell carcinoma and
soft-tissue sarcomas. The active ingredient in Leuvectin is a gene encoding interleukin-2 (IL-2), a naturally
occurring protein that stimulates the immune system. Administration occurs by direct injection into a tumor,
leading to uptake by the tumor cells and subsequent expression of the IL-2 protein. The company expects local
expression of IL-2 by cancer cells may stimulate the patient's immune system to attack and destroy the tumor
cells.
Recombinant IL-2 protein is an approved anti-cancer agent for the treatment of advanced kidney cancer. When
given systemically, it is frequently associated with serious side effects. Because Leuvectin delivers IL-2 locally
within the tumor, it may provide similar benefits with fewer side effects than the systemic protein therapy.
As a result of initial Phase I/II clinical testing of Leuvectin in several cancer indications, completed in 1996,
Vical concluded that the product candidate was safe and well-tolerated, successful in delivering the IL-2 gene in
a majority of patients, and effective in inducing tumor shrinkage in some patients. Leuvectin is being evaluated at
progressively higher doses in several cancer types.
Prostate cancer is the most frequently diagnosed type of cancer, and the second leading cause of cancer
fatalities, among men in the United States. African Americans are at significantly greater risk than Caucasians,
and men over age 65 account for over 80 percent of all diagnoses. More than 334,000 new cases are
diagnosed annually, with more than 41,000 deaths expected in 1997 in the United States.
Early detection, either by digital rectal exam or by prostate- specific antigen (PSA) blood test, has been
increasing the number of annual diagnoses and improving overall survival rates. Most patients are diagnosed
while the disease is confined to the prostate gland, with a five-year survival rate of 99 percent. If the disease is
discovered after it spreads to connective tissue, lymph nodes, or other internal organs, survival rates decline.
Treatment options include ``watchful waiting'' for older patients with no symptoms or with other more serious
illnesses, radiation therapy, and surgical removal of the prostate gland and/or affected lymph nodes. Symptoms
may also be relieved by hormone therapy or surgery.
Vical Incorporated is focused on the development of gene-based pharmaceutical product candidates for human
therapy. Vical's gene- based therapeutic approach may offer safer and more cost-effective alternatives for many
diseases, including cancer, infectious diseases and metabolic disorders.
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, 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.
Contact:
Vical Incorporated, San Diego
Alan R. Engbring, 619/453-9900 |
