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VICAL CONFIRMS ACTIVITY OF ALLOVECTIN-7 IN MELANOMA AND HEAD/NECK CANCER.


DENVER, CO--(BUSINESS WIRE)--May 17, 1997--

Clinical Trial Results Presented At ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
 Meeting

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 inoperable /in·op·er·a·ble/ (in-op´er-ah-b'l) not susceptible to treatment by surgery.

in·op·er·a·ble
adj.
Unsuitable for a surgical procedure.
 head and neck cancer. Results from both trials were presented at the annual meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. .

Although all melanoma patients enrolled in the multi-center Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 with Allovectin-7 had advanced metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , 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 An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient.  in Allovectin-7 is a gene encoding HLA-B7, an antigen responsible for strong immune responses such as organ transplant organ transplant: see transplantation, medical.  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 cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping.

See also: Cancer
 may trigger the patient's immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 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. -0-

Allovectin-7 Phase I/II Results in Melanoma
Disease     Patients     Local     Partial     Complete     Duration
Progression             Response   Clinical    Clinical
                                   Response    Response

Stage IV       36          13         6           1        8-33 months
                                                        and continuing




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 Lymph nodes
Small, bean-shaped masses of tissue scattered along the lymphatic system that act as filters and immune monitors, removing fluids, bacteria, or cancer cells that travel through the lymph system.
, 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. -0-

Initial Allovectin-7 Phase II Results in Melanoma
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


Allovectin-7 in Other Indications

Preliminary data from Phase II trials in the other four indications studied showed mixed results. In renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
, 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 non-Hodg·kin's lymphoma
n.
Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells.


Non-Hodgkin's lymphoma 
 remain under study, as preliminary data were insufficient to suggest any conclusions. Among 23 patients with advanced colorectal cancer colorectal cancer

Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat.
, 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. -0-

Initial Allovectin-7 Phase I/II Results in Head & Neck Cancer
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




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 sunburn, inflammation of the skin caused by actinic rays from the sun or artificial sources. Moderate exposure to ultraviolet radiation is followed by a red blush, but severe exposure may result in blisters, pain, and constitutional symptoms. . Exposure to sunlight, particularly UVB UVB ultraviolet B; see ultraviolet.  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 localized disease Medtalk Any condition, generally understood as malignant, which is confined to a tissue or organ. Cf Regional disease.  of varying diameter and thickness, melanoma often can be successfully treated by surgical removal. The five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free survival.  rate for localized malignant melanoma Malignant Melanoma Definition

Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin.
, 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 Metastasis (plural, metastases)
A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor.

Mentioned in: Malignant Melanoma
, 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 oral cavity
n.
The part of the mouth behind the teeth and gums that is bounded above by the hard and soft palates and below by the tongue and the mucous membrane connecting it with the inner part of the mandible.
, the pharynx pharynx (fâr`ĭngks), area of the gastrointestinal and respiratory tracts which lies between the mouth and the esophagus. In humans, the pharynx is a cone-shaped tube about 4 1-2 in. (11.43 cm) long.  or larynx larynx (lâr`ĭngks), organ of voice in mammals. Commonly known as the voice box, the larynx is a tubular chamber about 2 in. (5 cm) high, consisting of walls of cartilage bound by ligaments and membranes, and moved by muscles. , 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 Investor relations

The process by which the corporation communicates with its investors.


Vical Incorporated

(619) 646-1127
COPYRIGHT 1997 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 17, 1997
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