West Coast Editor

It's been a long, rocky road - which almost broke the company's axles and flattened its tires - but Northwest Biotherapeutics Inc. has gained FDA clearance to start a Phase III trial with its lead product, DCVax-Prostate, for cancer.

The company's stock jumped 86.5 percent Tuesday, but that rise worked out to only about 3 cents. The shares trade on the Over-the-Counter Bulletin Board (OTC BB: NWBT) and ended the day at 7 cents.

DC-Vax Prostate targets non-metastatic hormone-independent prostate cancer. No FDA-approved drug exists for the indication, but NBI might be able to change that eventually, thanks to a recapitalization deal disclosed in April of last year with Toucan Capital II LP, of Bethesda, Md.

Under the terms of the financing as explained at the time, NBI would get up to $40 million through the issuance of new securities to Toucan and a syndicate of investors. Following the deal, Toucan and the syndicate together would own more than 90 percent of the outstanding stock.

Alton Boynton, president and chief operating officer of the Bothell, Wash.-based firm, was traveling and could not be reached, but said in a press release that NBI had made "progress" with the Toucan deal.

DCVax-Prostate comes from NBI's dendritic cell-based immunotherapy platform. White blood cells are separated from the patient's blood at a clinical site and shipped to a processing center, where peripheral mononuclear cells are isolated, put in vials and stored in liquid nitrogen.

The cells are thawed and cultured for seven days with processing and maturation factors, after which they are put in vials again, frozen, tested, released and shipped back to the clinical site for injection, or they might be pulsed with tumor lysate, tumor-related antigens or antigen-associated peptides, then frozen, tested, released and shipped for use.

NBI already has the FDA's nod for a Phase II trial with a DCVax product for glioblastoma multiforme. The brain cancer trial is expected to start later this year. Preclinical work has been done for a Phase I trial for non-small-cell lung cancer and head and neck cancer.

Things didn't always look so good. In November 2002, with only $2.9 million in cash, NBI suspended all DCVax clinical trial activity, withdrew its investigational new drug application for it and for DCVax-Lung for non-small-cell lung cancer, and said it could not go ahead with the brain cancer trial without more cash. (See BioWorld Today, Nov. 11, 2002.)