CORONADO, Calif.--(BW HealthWire)--Nov. 24, 1997--Initial
results from 11 patients in Phase I/II dose-escalation trials
indicate that Leuvectin, a gene-based oncology product being
developed by Vical Inc. (NASDAQ:VICL), may provide clinical benefit
for certain patients with advanced metastatic renal cell carcinoma.
Responses appear to be dose-related, and no serious
treatment-related adverse events were reported, even at the highest
doses tested. The data were presented at the sixth International
Conference on Gene Therapy of Cancer by Dr. Evanthia Galanis of the
Mayo Clinic, one of seven clinical centers participating in the
trials.
Of the 11 renal cell carcinoma patients initially evaluable in
the Leuvectin trials, two achieved objective clinical partial
responses (no new tumors or tumor growth and reduction of greater than
50 percent in total tumor burden) persisting for more than six and
nine months, and two achieved stable disease (no new tumors and
reduction of less than 50 percent or growth of less than 25 percent in
total tumor burden).
Leuvectin is a DNA-based product candidate being studied in
melanoma, renal cell carcinoma, sarcoma and prostate cancer. 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 that 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 anticancer 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 five of 23 patients with various types of
advanced malignancies. In October 1996, the company initiated
additional multicenter Phase I/II clinical testing of higher doses of
Leuvectin in approximately 45 patients with advanced melanoma, renal
cell carcinoma or sarcoma. In June 1997, the company also initiated a
Phase I/II clinical trial with Leuvectin in approximately 18 prostate
cancer patients, in which accrual and treatment are ongoing.
Separate presentations at the conference by Dr. Evan Hersh, of
the Arizona Cancer Center, and Dr. Lyon Gleich, of the University of
Cincinnati Medical Center, updated and expanded previously disclosed
results confirming the efficacy of Allovectin-7 in certain patients
with melanoma and head and neck cancer. A noteworthy observation in a
Phase II study of advanced melanoma patients was a median survival
of 12 months among treated patients compared with a historical
median of eight months.
Allovectin-7 is a novel, gene-based product candidate being
studied in Phase II trials in patients with melanoma and head and
neck 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. 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 expects 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.
Vical Inc. 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 Inc., San Diego
Alan R. Engbring, 619/646-1127 (Investor Relations)
Robert H. Zaugg, 619/646-1127 (Business Development)
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICINE PHARMACEUTICAL PRODUCT
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