|Vical Presents Promising Interim Data From Phase II Allovectin-7(R) Melanoma Registration Trial at ASCO|
SAN FRANCISCO, May 14 /PRNewswire/ -- Dr. Rene Gonzalez (University of Colorado Medical Center), on behalf of the clinical centers working with Vical Incorporated (Nasdaq: VICL - news), presented promising interim safety and efficacy data from the company's Phase II Allovectin-7® registration trial for patients with late-stage metastatic melanoma at the annual meeting of the American Society of Clinical Oncology (ASCO).
Vijay B. Samant, Vical's President and Chief Executive Officer, said, ``These interim data are consistent with previously reported data, and may support a filing for marketing approval. We are excited by the durable nature of the systemic responses, which can provide a meaningful benefit to patients. The exceptional safety and tolerability of Allovectin-7®, both during the treatment cycle and throughout the response period, are particularly important in maintaining a good quality of life for patients.''
The company reported interim data for 73 patients who received at least one injection of Allovectin-7® (intent-to-treat patient population), including 54 patients who received at least one full treatment cycle (evaluable patient population). The conclusions based on these data were that the median duration of response and response rate to date confirm the activity of Allovectin-7®, and that the safety profile of Allovectin-7® remains excellent in comparison to approved treatments for metastatic melanoma. Several patients are still in treatment or followup under the Phase II trial, and final results are expected by year-end 2001. In addition, a concurrent Phase III Allovectin-7® registration trial is expected to complete enrollment of patients with newly diagnosed metastatic melanoma in the third quarter of 2001. Positive data from either trial could lead to marketing approval.
In the Phase II registration trial, treatment with Allovectin-7® resulted in a reduction in total tumor burden of 50 percent or more (systemic clinical responses) in 14.8 percent of the evaluable patients with a current median duration of response of approximately 5 months. Two of the patients, or 4 percent of the evaluable group, experienced complete responses in which all detectable tumors were eliminated. An additional 26 percent of the evaluable patients achieved stable disease, some with reductions in total tumor burden that are significant but did not reach 50 percent. On an intent-to-treat basis, 11 percent of the patients experienced systemic clinical responses, and an additional 19 percent achieved stable disease. The trial enrolled patients who have failed other treatments. All but 1 percent of the drug-related side effects were mild or moderate. Melanoma is currently treated with chemotherapy, biotherapy, or combinations of chemotherapy and biotherapy. Toxicity with such treatments is often significant, resulting in serious or life-threatening side effects in 50 percent or more of the patients treated.
``The continued excellent safety record of Allovectin-7® and the growing body of efficacy data support its potential to be the first gene-based product to gain marketing approval,'' added Mr. Samant. ``We will monitor the progress of patients remaining on study, and look forward to providing a complete report and guidance on the direction of our registration program by year-end.''
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 may absorb it and express the HLA-B7 antigen. This antigen may alert 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.
Vical's Allovectin-7® registration program consists of two separate trials in patients with metastatic melanoma, either or both of which could lead to registration for their respective patient populations if endpoints are achieved. The Phase II trial is designed to confirm the efficacy of Allovectin-7® in patients with refractory (unresponsive to standard therapy) melanoma that has not yet spread to multiple internal organs. The Phase III trial is designed to demonstrate the efficacy of Allovectin-7® when used with standard chemotherapy in patients with metastatic melanoma not previously treated with chemotherapy.
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 & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma, Human Genome Sciences, Centocor Inc., Merial and Boston Scientific Corporation. 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(TM), which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with 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. If you are interested in any of Vical's clinical trials, please see our website at www.vical.com, or contact Tammy Boyce by phone at 858/646-1120 or by e-mail at firstname.lastname@example.org.