SAN DIEGO--(BW HealthWire)--Sept. 4, 1997--Vical Incorporated
(NASDAQ:VICL) announced today the initiation of a multi-center Phase
II clinical trial to study the efficacy of Allovectin-7 in patients
with advanced or recurrent head and neck cancer. Patients will be
treated at more than ten clinical centers in the United States. The
first patients enrolled in the trial are being treated at the
University of Cincinnati Medical Center and at the University of
Arkansas for Medical Sciences. Results of a Phase I/II trial at the
University of Cincinnati showed evidence of potential clinical
efficacy in some head and neck cancer patients.
Alain B. Schreiber, M.D., Vical's President and CEO, said,
"Initial testing of Allovectin-7 in head and neck cancer has yielded
very encouraging results. We are excited by the potential
application of our technology in head and neck cancer patients who
have exhausted alternative treatments. We are also continuing with
our efforts toward development of Allovectin-7 for patients with
advanced melanoma and other solid tumors."
Allovectin-7
Allovectin-7 is a novel, gene-based product candidate being
studied in melanoma and other types of cancer. The active
ingredient in Allovectin-7 is a gene encoding HLA-B7, an antigen
responsible for strong immune responses such as organ transplant
rejection. To improve delivery, the gene is complexed with a
proprietary lipid and suspended in a water-based solution.
Administration occurs by direct injection into a tumor, leading to
uptake by the tumor cells and subsequent expression of the HLA-B7
antigen. The Company believes that the expression of HLA-B7 by
cancer cells may trigger the patient's immune system to recognize
these cells as "foreign" and selectively destroy the tumor. Results
of Phase I/II clinical testing of Allovectin-7 in several cancer
indications indicated that the product candidate is safe and
well-tolerated, successful in delivering the HLA-B7 gene in a
majority of patients, and may be effective in inducing tumor
shrinkage in some patients.
Allovectin-7 in Head and Neck Cancer
Allovectin-7 has been evaluated in a Phase I/II trial for
patients with advanced, inoperable or recurrent post-surgical head
and neck cancers. In four of the ten patients treated to date,
administration of Allovectin-7 has resulted in substantial and
lasting clinical responses.
Head and Neck Cancer Background
Head and neck cancer describes any of several localized tumors
affecting the oral cavity, the pharynx or larynx, or the esophagus.
Head and neck cancers occur more frequently in men than in women,
and most often in men over age 40. Risk factors vary with the
physical location, but can include use of tobacco and excessive
consumption of alcohol. New diagnoses in the United States for the
various head and neck cancers total more than 50,000 new cases
annually and it is estimated that more than 20,000 people will die
from these cancers in 1997.
Most head and neck cancers are treated by surgical removal
and/or localized radiation therapy, with varying degrees of success
depending on the number of tumors, their size, and their specific
location. In advanced or recurrent disease, surgery often is no
longer viable and radiation and chemotherapy have not proven
effective. The five-year survival rate for patients with
widespread, inoperable malignancies is less than 5 percent.
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 Allovectin-7 or any other 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 or Robert H. Zaugg, Ph.D.
619/453-9900
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL MEDICINE
Today's News On The Net - Business Wire's full file on the Internet
with Hyperlinks to your home page.
URL: businesswire.com
Copyright 1997, Business Wire |
