Vical Releases Allovectin-7 Results At International Head and Neck Cancer Conference
SAN FRANCISCO--(BW HealthWire)--Aug. 1, 2000--Vical Incorporated (Nasdaq:VICL) released results from Phase I and Phase II clinical studies and concluded that treatment with Allovectin-7(R) appears to be safe and that further studies are warranted in patients with less-advanced head and neck cancer. Results from three sequential clinical trials testing Allovectin-7(R) in patients with advanced squamous cell carcinoma of the head and neck were presented by Lyon L. Gleich, M.D. (University of Cincinnati Medical Center), at the Fifth International Conference on Head and Neck Cancer. The company is planning a new study in patients scheduled for surgical treatment of earlier-stage head and neck cancer.
Data were compiled from a single-center, Phase I study and two multi-center, Phase II studies for patients with unresectable head and neck cancer who had failed to respond to conventional therapies. Of 60 HLA-B7 negative patients from the three trials, 6 patients achieved clinical responses (50 percent or greater reduction in tumor burden), and 14 achieved stable disease (less than 50 percent reduction or less than 25 percent increase in tumor burden), upon completing the first treatment cycle. The 20 responding or stable patients went on to a second treatment cycle. Upon completing the second treatment cycle, five patients had a partial response, six patients had stable disease. The duration of response for the five responding patients ranged from 20 to 79 weeks. The duration of response for the six stable patients ranged from 18 weeks (and remaining stable) to 34 weeks. Allovectin-7(R) was generally well-tolerated, with no serious drug-related side effects. Deirdre Y. Gillespie, M.D., Vical's Chief Operating Officer, said, "We are eager to move forward with an additional study designed for earlier-stage patients, a population whose disease and prior treatments have not compromised the immune system."
Allovectin-7(R) is a DNA/lipid complex containing the human gene encoding the HLA-B7 antigen. This antigen alerts the immune system to the presence of foreign tissue, and may trigger an immune response against tumor cells.
Advanced Head and Neck Cancer
In advanced head and neck cancer, radical surgery and/or radiation therapy 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 with widespread, unresectable malignancies is less than 5 percent. The median survival for patients with local and disseminated recurrent head and neck cancer is about 6 months. These statistics have not been affected by chemotherapy or other experimental agents to date.
Allovectin-7(R) in Melanoma
As previously reported, Vical also is conducting studies of Allovectin-7(R) in metastatic melanoma. Enrollment of patients in the company's Phase II trial is nearing completion, and enrollment of patients in the Phase III trial is progressing toward possible completion in the first half of 2001. Dr. Gillespie said, "Recruitment of patients into our Phase III trial, our first melanoma trial designed for patients who have a significant choice of treatment alternatives, remains our highest priority and our greatest challenge. We believe that Allovectin-7(R) may have the potential to fulfill a significant, unmet need in the treatment of metastatic melanoma."
Vical Incorporated, The Naked DNA Company(TM), is focused on the development of pharmaceutical product candidates based on its patented gene delivery technology. A number of therapeutic and vaccine product candidates are currently under development for the prevention or treatment of cancer, infectious diseases and metabolic disorders by Vical and its collaborative partners, including Merck, Pfizer, Aventis Pasteur, Aventis Pharma, Centocor, Human Genome Sciences, Merial and Boston Scientific. Allovectin-7(R), which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with head and neck cancer. Leuvectin, which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with kidney cancer and prostate cancer. Vaxid, a naked DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing. In collaboration with the National Cancer Institute, a naked DNA vaccine to treat metastatic melanoma is in Phase I/II testing.
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, whether Vical will seek or gain approval to market any product candidates, 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.
For news releases and other information about the company, visit the Vical web site at www.vical.com.
CONTACT:
Vical Incorporated
Alan R. Engbring, Director, Investor Relations
858/646-1127 |
