Business Wire - May 12, 2000
The company said all of the 43 centers participating in the trials nationwide are actively enrolling and treating patients with advanced metastatic melanoma. The DSRB is composed of leading oncologists and statisticians who are not participating in the Allovectin-7 trials. The DSRB examined safety and preliminary efficacy data for both a randomized, controlled Phase III trial and for a single-arm, expanded Phase II trial.
Deirdre Y. Gillespie, M.D., Vical's Chief Operating Officer, said, "We are very pleased that the DSRB has confirmed the safety of Allovectin-7 based on available data, and that all of our participating centers are actively recruiting patients."
Allovectin-7
Allovectin-7 is a DNA/lipid complex containing the human gene encoding the HLA-B7 antigen. Allovectin-7 is designed to be injected directly into a tumor, where malignant cells absorb it and express the HLA-B7 antigen. This antigen alerts the immune system to the presence of foreign tissue, inducing the type of powerful immune response seen in organ transplant rejection. In addition, the treatment may trigger an immune response against additional tumor cells, both locally and systemically, by enabling the immune system to recognize other features of the tumor cells. Allovectin-7 is currently in advanced clinical testing for patients with metastatic melanoma.
Allovectin-7 Registration Trials in Melanoma Patients
Vical is conducting two separate clinical trials in patients with advanced melanoma, either or both of which could lead to registration for their respective patient populations if endpoints are achieved.
Expanded Phase II Clinical Trial
The open-label, multi-center Phase II trial is designed to confirm the efficacy of Allovectin-7 in the defined patient population which appeared to benefit most in earlier Phase II trials. Enrollment is open to patients with metastatic (spread beyond the initial site), refractory (unresponsive to standard therapy), Stage III or IV disease that has not yet spread to multiple internal organs. Up to 70 advanced melanoma patients will be enrolled at leading cancer treatment centers throughout North America. The objective is a clinical partial or complete response in at least 15 percent of the evaluable patients, persisting with a median duration of at least four months.
Phase III Clinical Trial
The open-label, multi-center, randomized, controlled Phase III trial is designed to determine the efficacy of Allovectin-7 when combined with standard chemotherapy in patients with unresectable, metastatic melanoma not previously treated with chemotherapy. In prior trials, Allovectin-7 was used only after standard therapies had failed. In the new trial, patients may be enrolled upon diagnosis or upon progression to Stage III or Stage IV disease when surgery or radiation therapy are usually no longer curative. Because Allovectin-7 is intended to trigger an immune response against tumor cells, the company believes the treatment may be more effective in patients whose immune systems have not been compromised.
Approximately 140 patients per group, randomized by sex, age, and extent of disease spread, will be enrolled into a chemotherapy-plus-Allovectin-7 experimental group or a chemotherapy-only control group. The objective is a greater relative clinical benefit for the experimental group than for the control group. Acceptable endpoints are either a significant improvement of the median time to disease progression with no decrease in the rate of objective clinical responses, or an improvement of at least 15 percent in the rate of objective clinical responses with no decrease in the median time to disease progression.
Metastatic Melanoma
Melanoma is a skin cancer found predominantly in Caucasians, particularly in fair-skinned individuals who have experienced repeated sunburn. According to American Cancer Society statistics, 47,700 new cases of melanoma will be diagnosed in the U.S. and 7,700 patients will die from this disease in 2000. The National Cancer Institute estimates that about 480,000 Americans currently suffer from malignant melanoma.
If detected when the disease is still limited to one site, known as stage I and II, melanoma usually can be treated successfully by surgery. If untreated, the disease frequently spreads to the lymph glands, lungs, liver, brain and other organs. Stage III is defined as metastatic disease limited to one region and is treated with a combination of surgery and chemotherapy. Stage IV disease involves advanced regional or any distant tumors and treatment normally includes some combination of chemotherapy, radiotherapy, and surgery.
The five-year survival of patients with stage III and stage IV disease is 59 percent and 12 percent, respectively. In patients whose disease continues to progress after they have received all available treatments, the average survival is seven to nine months.
Vical Inc., 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, 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 Inc. Alan R. Engbring, 858/646-1127
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