A day after getting the nod from the FDA for a Phase III trial protocol to test the Provenge prostate cancer vaccine, Dendreon Corp. raised $26.7 million through a stock sale to help finance the effort.
"We also have a breast, ovarian and colon cancer vaccine and a lineup of preclinical products," said Julie Rathbun, manager of communications and investor relations for Seattle-based Dendreon, noting some of the money might be used for those but most would go for Provenge development.
The company sold 3.8 million shares at $7 each to Baystar Capital, of San Francisco; Mazama Capital Management, of Portland, Ore.; and an existing shareholder.
Provenge, an immune-system stimulator, has been the subject of a Phase III trial already.
"It did not meet its primary endpoint but there was a subgroup of men with Gleason scores of 7 or less," who showed benefit, Rathbun said.
That trial, called D9901, reaped significant benefit for such patients in delaying time to disease progression and the development of disease-related pain, as well as providing a significant T-cell-mediated immune response.
The Gleason score, named after the physician who developed it, is established by examining under a microscope prostate cells from the two largest areas of cancer.
"Our protocol was amended to include men with Gleason scores of 7 or less," Rathbun said, for a trial called D9902B, which the FDA said can be the basis for a biologics license application. The trial is expected to enroll about 275 patients at more than 60 medical centers in the U.S.
Also in the works is Dendreon's buyout of Corvas International Inc., of San Diego, in a $72.9 million stock swap. (See BioWorld Today, Feb. 26, 2003.)
"The latest guidance has been that it will be [concluded] within 60 days," Rathburn said, adding that the filing is under review.
Dendreon s stock (NASDAQ:DNDN) closed Friday at $7.66, down 55 cents, but had gained 72 cents, or 26.4 percent Wednesday on the protocol news from the FDA, ending that day at $8.45, closed Thursday $8.21.