By Kim Coghill
Vical Inc. is initiating two new trials of its cancer product Allovectin-7 while it continues progress on a Phase III trial for use of the drug in patients with newly diagnosed metastatic melanoma.
San Diego-based Vical expects to meet with the FDA this quarter to discuss the Phase III trial status and to review options for completion, said Alan Engbring, Vical's director of investor relations. "We will know much more after the meeting," he said.
The Phase III study, the company's most advanced trial, continues to enroll patients with newly diagnosed metastatic melanoma at more than 40 clinical sites nationwide. The controlled, randomized trial is studying whether there is an improvement in the time to disease progression with no decrease in rate of objective clinical response, or an improvement of at least 15 percentage points in the response rate with no decrease in the median time to disease progression.
Engbring said the company has not entered a licensing agreement or a partnership with Allovectin-7. "This is totally a Vical program at this point. We will probably wait until we have results from trials before we look into those programs," he said. "But Vical is prepared to launch these programs alone."
Allovectin-7 also is being tested in a multicenter Phase II trial in 80 patients with late-stage metastatic melanoma to refine its use in clinical practice. The product is a DNA lipid complex containing the human gene encoding the HLA-B7 antigen.
In previous trials, Engbring said, small doses of Allovectin-7 were delivered to a single tumor lesion. However, the product's current safety profile allows Vical to design the new Phase II trial to test higher doses (up to 2 mg, a 200-fold increase) and deliver it to multiple tumor lesions.
Enrollment of the lower-dose Phase II trial for patients with late-stage metastatic melanoma has been completed and updates on the results are expected in the second quarter. That study is designed to support product registration.
In another indication, Vical has started a multicenter Phase II trial of Allovectin-7 in up to 25 patients scheduled for surgical treatment of early stage cancer of the oral cavity and oropharynx.
Patients will receive two doses of Allovectin-7 followed by surgical intervention. The primary goal is reduction in tumor size prior to surgery. Additional objectives include assessment of the immune response to Allovectin-7, safety and analysis of the time to disease progression.
Vical has other therapeutic and vaccine product candidates in development for the prevention or treatment of cancer, infectious diseases and metabolic disorders in conjunction with its collaborative partners, including Merck & Co., of Whitehouse Station, N.J.; Pfizer Inc., of New York; Aventis Pasteur SA, of Lyon, France; Aventis Pharma AG, of Frankfurt, Germany; Human Genome Sciences Inc., of Rockville, Md.; Centocor Inc., of Malvern, Pa.; Merial Animal Health, a joint venture of Rhone-Poulenc Group and Merck; and Boston Scientific Corp., of Boston.
The company's other products in trials include Leuvectin and Vaxid.
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. Also, in collaboration with the National Cancer Institute, is a naked DNA vaccine to treat metastatic melanoma in Phase I/II testing.
Vical's stock (NASDAQ:VICL) closed Friday at $15.812, down 43.7 cents. n