very, very cool..........
Pfizer Stops Cancer Drug Test Early Due To Effectiveness
Tuesday February 1, 4:20 PM EST
NEW YORK -(Dow Jones)- Pfizer Inc. (PFE) halted the clinical trial for its stomach-cancer drug early because it was proven effective.
The data monitoring board, which is made up of independent researchers, recommended to stop the trial because it met its targets. SU11248 treats gastrointestinal stromal tumors in patients where the standard treatment, Novartis AG's (NVS) Gleevec, is ineffective. The move greatly speeds up the approval process for the Pfizer drug, which one analyst says could come as early as this year.
News of the recommendation first appeared Sunday in a note on patient Web site GIST Support International by George D. Demetri, an expert with the Dana-Farber Cancer Institute who was one of the scientists conducting the SU11248 study.
"This data monitoring board for this study has now recommended that this trial can stop immediately due to having successfully met its efficacy endpoint," he wrote.
Pfizer spokesman Paul G. Fitzhenry confirmed in an e-mail Tuesday that the trial was halted.
The New York company is in the position to file for Food and Drug Administration approval of SU11248 as early as the first quarter, said SunTrust Robinson Humphrey analyst Robert Hazlett. The drug could be on the market as early as the second half of the year.
Gleevec, which selectively targets the receptor tyrosine kinase KIT, is typically effective against GIST. But Gleevec stops working in 75% of patients after about two years, creating the potential for the use of SU11248 either in combination or after Gleevec therapy, Hazlett said in a research note Tuesday.
The drug could also have a role in treating other kinds of cancer. In the fourth quarter, Pfizer completed enrollment of the drug in a second-line renal cell carcinoma trial. The analyst said there is the chance Pfizer could file for an accelerated FDA approval. The drug is also being considered for the treatment of breast and small-cell lung tumors.
Hazlett doesn't own a stake in Pfizer, and SunTrust doesn't have an investment-banking relationship with the company.
As a result of the recommendation, Pfizer's regulatory risk has improved, said Friedman Billings Ramsey analyst David Moskowitz. SU11248 represents a small, but important, advance in the development of its oncology pipeline, which Pfizer considers a growth area.
While the GIST market is small, with about 1,000 to 5,000 incidents a year, it should lead to larger markets like renal cancer, which has about 30,000 occurrences a year, he said in a note.
Moskowitz doesn't own a stake in Pfizer, but his firm may be seeking an investment-banking relationship.
Pfizer recently traded at $23.86, down 30 cents, or 1%, on volume of 49 million shares. Average daily volume is 41 million shares.
- By Roger Cheng, Dow Jones Newswires; 201-938-5393; roger.cheng@dowjones.com
Dow Jones Newswires
02-01-05 1620ET |
