Northwest Biotherapeutics Inc. said it is suspending recruitment in a Phase III trial of its lead prostate cancer drug, selling some fixed assets and considering options for the future.
NBI's stock (NASDAQ:NWBT) closed Thursday at 31 cents, up 6 cents, or 24 percent.
Daniel Wilds, president and CEO of Bothell, Wash.-based NBI, said through a spokeswoman that the company would have no further comment on the developments. Using dendritic cell biology and antigen discovery methods, NBI has devised two platforms: dendritic cell-based DCVax (from which came the Phase III drug, DCVAX-Prostate) and the monoclonal antibody-based HuRx which grew out of a partnership with Medarex Inc., of Princeton, N.J., and yielded HuRx-Prostate, another cancer treatment, which is being manufactured for Phase I trials yet to begin. (See BioWorld Today, April 26, 2001.)
NBI also has been cleared by the FDA to begin a multisite Phase II clinical trial to test DCVax-Brain as a treatment for glioblastoma multiforme, a lethal form of brain cancer, and a Phase I trial of DCVax-Lung for lung cancer.
Earlier this week, the company was notified that it has until Jan. 6 to meet the minimum per-share bid price of $1 for 10 consecutive trading days. If NBI doesn't meet the standard, it can apply for SmallCap status or be delisted.
The firm has retained C.E. Unterberg, Towbin in New York to help with strategic and financial alternatives, including the sale or merger of the company.
Unterberg did not return phone calls, but in May said it favored NBI over its main competitor in the field of dendritic-cell research against prostate cancer, Dendreon Corp., of Seattle, declaring NBI was "apt to beat" Dendreon to market with a drug for the indication. That was after the FDA told Dendreon to stop enrolling patients in a Phase III prostate cancer study called D9902 with its drug, Provenge, due to questions related to product characterization. (See BioWorld Today, May 2, 2002.)
Dendreon since has produced data from a separate Phase III trial with the drug, narrowly missing the primary endpoint but showing benefit in men with a Gleason score, which measures aggressiveness of a tumor, of 7 or less. Dendreon said 75 percent of hormone-resistant patients have a Gleason score of 7 or less, and the company's stock jumped 45 percent on the news. (See BioWorld Today, Aug. 12, 2002.)