Novacea Inc. pulled in $36 million in its Series B round of financing, a sum the company says is validated by its drug in a later-stage trial and a solid group at the top.

"We have a great product and a great management team," said Brad Goodwin, Novacea's CEO. "[Our product] DN-101 is in Phase II/III and may be able to address unmet medical needs in cancer. That stood out."

A good portion of the financing will be used to back the development of DN-101 - not only in the Phase II/III prostate cancer trial, but also in additional indications - as well as provide the financial muscle to fatten Novacea's pipeline.

"We [now] have sufficient funds to explore multiple indications for DN-101 and to license in additional products for clinical development," Goodwin told BioWorld Today.

South San Francisco-based Novacea has DN-101, its own formulation of calcitriol, in the ASCENT trial, which began in September. The trial is examining DN-101 in combination with Taxotere (docetaxel) in 232 androgen-independent prostate cancer patients. The study involves 20 sites and is randomized and double blind. Novacea is planning on studying other cancer indications for the drug also, and, after analyzing data, will make a decision concerning which indication to take into Phase III trials. (See BioWorld Today, Sept. 19, 2002.)

"What we are hoping and planning is we will complete enrollment [for the Phase II/III] trial in the next 12 months," Goodwin said, adding that by the end of 2003 the company should be able to see early data. "At that point, we would begin internal planning for a Phase III program."

That could mean one or more registration studies beginning in 2004, he said. While the current trial is partnered with the maker of Taxotere, Paris-based Aventis SA, and the pharmaceutical company is helping to sponsor the trial, DN-101 is still wholly owned by Novacea.

"[Aventis] collaborates with us on the Phase II/III in prostate cancer," Goodwin said. "But they don't have any product rights to it. What we do beyond that [in terms of partnering], we will base that on the data we have at that time and on" potential partners. But Novacea does intend to at least partially commercialize its products itself, he said.

Novacea has 12 employees. The financing also will be used to expand the company's internal head count. Concurrent with the financing, the company added Michael Raab, of New Enterprise Associates, and Camille Samuels Pearson, of Versant Ventures, to its board. Samuels has experience as director of business development at Tularik Inc., of South San Francisco, and Raab was senior vice president, therapeutics and general manager, Renagel, at Cambridge, Mass.-based Genzyme Corp. The additions bring Novacea's board of directors to seven, and give the company what Goodrich called "a great background in commercialization and development of products."

The company is focused on hematology and oncology. Both Goodrich and John Curd, president and chief medical officer, said that in-licensed products would be in those areas. It's too early to tell when another product might be brought on board, but Goodrich said the company is "actively looking at product opportunities now." The financing only makes that easier.

"We think this sets us up very well to more comprehensively develop and license additional products, and round out the management team," he said.

The round was led by New Enterprise Associates, of Menlo Park, Calif., and Versant, also of Menlo Park. Also participating were Domain Associates, of Princeton, N.J.; ProQuest Investments, of Princeton; and Sofinnova Ventures, of San Francisco.