Novacea ends late-stage trial of prostate cancer drug

BANGALORE (Reuters) - Drugmaker Novacea Inc ended a late-stage trial of its prostate cancer drug Asentar, after a treatment arm containing the drug showed a higher death rate compared with the standard care, driving shares down more than 69 percent to a lifetime low.

South San Francisco-based Novacea also put its mid-stage trial for Asentar in advanced pancreatic cancer on hold, company spokesman Paul Laland said by phone.

The main goal of the prostate cancer trial was overall survival, which is the time from the date of randomization to the time of death from any cause.

The study compared the benefits of a weekly dose of Asentar in combination with Sanofi-Aventis' chemotherapy, Taxotere, to the current standard of care, which is Taxotere combined with a steroid, in the treatment of androgen-independent prostate cancer (AIPC).

AIPC is a condition where prostate cancer cells do not depend on androgen for growth. Androgens are hormones responsible for male characteristics, and the development and function of male sexual organs.

"We still believe Asentar has potential as a cancer treatment but we need to take the time to fully understand the reason for the unexpected outcome," Laland said.

To date, more than 900 of the planned total of 1,200 patients had been enrolled in this study.

The company said it suspended enrolment in other ongoing or planned trials for other indications, until further assessment of data.

The company, which is developing Asentar with Schering-Plough Corp, said the drug development alliance would continue.

"We believe that this announcement casts uncertainty over the future of the company's Asentar partnership with SGP (Schering-Plough), though NOVC indicated that the product alliance will continue," Bear Stearns analyst Akhtar Samad said in a note to clients.

Samad downgraded Novacea to "underperform" from "outperform."

Novacea shares fell $4.55 to $2.64 in late-afternoon trade, making it the biggest percentage loser on the Nasdaq. They hit a lifetime low of $2.21 earlier in the session.

Shares of Schering-Plough were trading down 1.97 percent at $29.37 on the New York Stock Exchange.

(Additional reporting by Ankur Relia)