Vical Inc. might start looking for possible partners for its cancer drug, Allovectin-7, after reaching an agreement with the FDA for a Phase III trial.
The San Diego-based company completed a special protocol assessment that outlined trial objectives, clinical endpoints and necessary analyses related to the high-dose (2 mg) study of Allovectin-7 in certain patients with metastatic melanoma.
Shares of Vical (NASDAQ:VICL) rose 9 cents Thursday to close at $5.10.
With a pivotal trial set to begin, Vical said it can advance partnership discussions and determine whether another company could assist with further product development and commercialization. The company declined to comment Thursday, but said it will provide additional information on the program during a conference call scheduled Tuesday to report fourth-quarter and year-end earnings.
Allovectin-7, a DNA plasmid/lipid complex containing the human genome encoding HLA-B7, is designed to augment immune response after being directly injected into the tumor. Vical said the Phase III trial will compare response rates of patients who receive Allovectin-7 to chemotherapeutic agents dacarbazine or temozolomide.
The open-label, multicenter trial is to enroll about 375 patients who have not received any chemotherapy treatments, though they may have been treated with surgery, adjuvant therapy and/or biotherapy. About 250 patients will receive Allovectin-7, while 125 will receive either dacarbazine or temozolomide. The primary endpoint will focus on response rates from patients in both groups at 24 weeks or more after randomization.
The study also is set to expand safety and tolerability data, though Vical reported that Allovectin-7 was found to be safe and well tolerated following a 133-patient Phase II trial that wrapped up last year. Vical presented interim results at the American Society of Clinical Oncologists conference in June, citing no reported Grade III or Grade IV adverse effects.
Additional data reported on the Phase II trial in November also indicated a total of 15 responders of the 127 patients (about 11.8 percent) evaluated. Four patients showed complete responses and 11 indicated partial responses to the treatment. Other results included the Kaplan-Meier estimated median duration of response at 12.7 months and estimated median survival at 21.3 months.
The high-dose clinical program for metastatic melanoma was the only Allovectin-7 program to survive Vical's pipeline reduction in September 2002. The company announced it was abandoning two studies involving its immunotherapeutic drug, including a Phase III low-dose trial of Allovectin-7 in metastatic melanoma that Vical said likely would not achieve the desired endpoints. A Phase II trial evaluating the product in early stage head and neck cancer was halted, due to difficulty in recruiting patients. (See BioWorld Today, Sept. 19, 2002.)
Vical recently has focused much of its resources on developing vaccines for infectious diseases. In July, the company began a Phase I trial of its DNA vaccine for anthrax to test the prophylactic, cationic lipid-formulated, bivalent plasmid product in as many as 52 healthy volunteers for safety and immune responses. Secondary endpoints include the immunogenicity of the vaccine at various doses and regimens. Depending on trial results, Vical might consider larger trials to support marketing approval under the FDA's animal rule.
The anthrax trial is supported by the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md.
Vical also is developing a DNA-based vaccine against cytomegalovirus.