Clinical Trial Results Presented At ASCO Meeting
DENVER, CO--(BUSINESS WIRE)--May 17, 1997--
Vical Incorporated (NASDAQ:VICL) announced today that initial
Phase II data for Allovectin-7, the Company's lead oncology product
candidate, indicate potential efficacy in certain patients with
advanced melanoma. Preliminary results from a separate Phase I/II
trial indicated potential efficacy in certain patients with
inoperable head and neck cancer. Results from both trials were
presented at the annual meeting of the American Society of Clinical
Oncology.
Although all melanoma patients enrolled in the multi-center
Phase II clinical trial with Allovectin-7 had advanced metastatic
disease, initial results further suggest that the potential
treatment may be more effective in patients with advanced regional
disease than in patients with widespread disease affecting multiple
internal organs. Alain B. Schreiber, M.D., Vical's President and
CEO, said, "These results support our decision to perform studies
focused on melanoma, and suggest a clear strategy for development of
an initial product indication. We now have information that may
allow us to target the melanoma patient population most likely to
benefit from Allovectin-7."
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 expects 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. As a result
of Phase I/II clinical testing of Allovectin-7 in several cancer
indications, completed in 1995, Vical concluded that the product
candidate was safe and well-tolerated, successful in delivering the
HLA-B7 gene in a majority of patients, and effective in inducing
tumor shrinkage in some patients.
Multi-center Phase II trials of Allovectin-7 began in September
1995, studying five different cancer indications in about 20
patients each. In October 1996, Vical initiated an additional
multi-center trial in which approximately 40 patients with advanced
metastatic melanoma are currently being enrolled and treated.
Several additional Phase I/II trials are ongoing, studying
Allovectin-7 either alone or in combination with other agents in
various cancer indications.
Allovectin-7 in Melanoma
Vical's Allovectin-7 melanoma trials to date have been conducted
in Stage IV patients who have failed to respond to chemotherapy or
radiation treatments. Phase I/II Allovectin-7 trials resulted in
significant (greater than or equal to 50%) local tumor shrinkage in
13 of 36 melanoma patients. Seven patients were considered partial
clinical responses, and one of the seven attained a complete
response and remains tumor-free more than 33 months later.
Allovectin-7 Phase I/II Results in Melanoma
*T
Disease Patients Local Partial Complete Duration
Progression Response Clinical Clinical
Response Response
Stage IV 36 13 6 1 8-33 months
and continuing
*T
Preliminary Phase II results confirmed the potential efficacy of
Allovectin-7 in treating melanoma patients, and suggested a
correlation between disease spread and such potential efficacy.
Among 11 melanoma patients with advanced disease involving the skin
or underlying tissue, regional lymph nodes, and no more than one
other internal organ, 5 patients exhibited tumor shrinkage with 3 of
those characterized as partial clinical responses. In 16 patients
with widespread advanced disease affecting multiple internal organs,
only 1 exhibited tumor shrinkage.
Initial Allovectin-7 Phase II Results in Melanoma
*T
Disease Patients Local Partial Complete Duration
Progression Response Clinical Clinical
Response Response
Stage IV
limited to
cutaneous 11 5 3 0 4-10 months
region or and
lymph nodes continuing
Stage IV
affecting
multiple 16 1 0 0 --
internal
organs
*T
Allovectin-7 in Other Indications
Preliminary data from Phase II trials in the other four
indications studied showed mixed results. In renal cell carcinoma,
8 of 25 patients had stable disease from 4 to 13 months after
treatment, and they continue to be monitored. Patients with breast
cancer and non-Hodgkin's lymphoma remain under study, as preliminary
data were insufficient to suggest any conclusions. Among 23
patients with advanced colorectal cancer, no responses were noted.
Allovectin-7 in Head and Neck Cancer
Allovectin-7 is also being evaluated in a separate Phase I/II
trial for patients with advanced, inoperable or recurrent
post-surgical head and neck cancers. Of the eight patients treated
to date, three have achieved partial clinical responses, two
considered near-complete. Patient accrual and treatment are
ongoing.
Initial Allovectin-7 Phase I/II Results in Head & Neck Cancer
*T
Disease Patients Local Partial Near- Duration
Progression Response Clinical Complete
Response Response
Inoperable 4-16 months
Stage III 8 3 1 2 and
or IV continuing
*T
Schreiber said, "The positive early results with Allovectin-7 in
treating advanced head and neck cancers certainly warrant further
study. The emerging pattern of potential product activity in
melanoma patients is encouraging."
Melanoma Background
Melanoma is a skin cancer found predominantly in Caucasians,
most often in fair-skinned people susceptible to sunburn. Exposure
to sunlight, particularly UVB rays, is considered the primary cause.
The incidence of melanoma is doubling every 6 to 10 years among
affected populations, with more than 40,000 new cases annually and
7,000 deaths estimated for 1997 in the United States.
If detected in Stages I and II, defined as localized disease of
varying diameter and thickness, melanoma often can be successfully
treated by surgical removal. The five-year survival rate for
localized malignant melanoma, if treated, is about 95 percent.
If untreated, melanoma spreads to tissues beneath the skin and
to internal organs, most often the lymph glands, lungs, brain, or
liver. If the disease progresses to Stage III, defined as limited
regional metastases, treatment may involve surgical removal of the
tumors and any affected lymph glands, followed by systemic or local
chemotherapy with single or multiple agents. The five-year survival
rate for treated Stage III patients is about 60 percent, and quality
of life is compromised by both the disease and the treatment.
If the disease progresses to Stage IV, defined as advanced
regional or any distant metastases, treatment may include surgical
removal of tumors and affected lymph glands, systemic or local
chemotherapy, radiation therapy, and immunotherapy. The prognosis
is poor, with a five-year survival rate for treated Stage IV
patients of about 15 percent and a severely impaired quality of life.
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 are found more frequently in men than in
women, and most often in men over age 40. Risk factors vary with
the particular 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 more than 20,000 deaths are estimated for
1997.
Most head and neck cancers are treated by surgical removal
and/or localized radiation therapy, with widely ranging degrees of
success depending on the number of tumors, their size, and their
specific location. In advanced disease, standard treatment may be
preceded by systemic chemotherapy to improve treatability, or
followed by systemic chemotherapy to address remaining cancer cells,
most often with a combination of agents. The five-year survival
rate for head and neck cancer patients, if treated, varies from more
than 90 percent for localized, accessible disease to less than 5
percent for widespread, inoperable malignancies.
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: Alan R. Engbring
Director, Investor Relations
Vical Incorporated
(619) 646-1127
KEYWORD: COLORADO
INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL PRODUCT |
