Still waiting to price its initial public offering, Favrille Inc. began a Phase III trial of its lead product, FavId.

The San Diego-based company is testing the immunotherapy drug for the treatment of the most prevalent form of indolent lymphoma, follicular B-cell non-Hodgkin's. Favrille expects that its regimen would provide patients the option of an all-biologic therapy that avoids many of the side effects associated with chemotherapy.

The pivotal trial, called FavId-06, is based on a design approved through the FDA's special protocol assessment process. The privately held company received the agency's blessing in May.

Company executives could not comment due to SEC-imposed quiet-period regulations related to the IPO, for which Favrille registered in April.

The randomized, double-blind study will compare the median time to disease progression for patients receiving FavId or placebo following treatment with Rituxan (rituximab, Genentech Inc.). The U.S.-based trial is expected to enroll 342 patients who are either treatment-na ve or who have relapsed after previously receiving up to two treatments for follicular B-cell non-Hodgkin's lymphoma.

Funding for the study will come in part from Favrille's recent third-round financing, which raised $44 million. Since its January 2000 inception, the company has raised $77 million. (See BioWorld Today, April 8, 2004.)

To date, FavId has been evaluated in two Phase II trials that involved more than 120 patients. Preliminary results from the studies suggested that the drug is active when used alone and might increase time to disease progression following treatment with Rituxan. Findings from one of the studies showed that one patient had a complete response and three had partial responses, while four others demonstrated a minor response. An additional 14 patients demonstrated stable disease, and the median time to disease progression for all 27 patients was 12.3 months.

Four additional physician-sponsored Phase II trials in other types of B-cell NHL are either ongoing or expected to begin this year, and Favrille expects to begin another Phase II study in the first quarter.

The patient-specific protein is formulated by conjugating it to a large immunostimulatory protein called keyhole limpet hemocyanin, or KLH. FavId is combined with a natural immune system growth factor called GM-CSF to enhance its immunostimulatory properties prior to injecting it back into the patient.

The company owns all rights to FavId, and at the time of completing its Series C financing in the spring, said it planned to retain such rights for as long as possible.

Aside from FavId, the company is developing a vaccine called FAV-201 for T-cell lymphoma and in the next quarter plans to begin a Phase I/II trial of the product. Other plans in the second half of this year include beginning preclinical studies to identify additional product candidates for the treatment of autoimmune diseases, with an initial focus on multiple sclerosis.

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