By Brady Huggett
Cell Pathways Inc.¿s stock crashed and then fought back Friday on news that a planned Independent Data and Safety Monitoring Board review of its Phase III trial with Aptosyn and Taxotere in patients with non-small-cell lung cancer will be accompanied by a suspension in enrollment.
The double-blind pivotal trial, involving non-small-cell lung cancer patients who have failed prior platinum-based chemotherapy, will go into a holding pattern while the board reviews the data and then reports its findings to the FDA by early November. The roughly 200 patients who have been enrolled will continue to receive treatment while the review is under way.
¿I think people just react to news,¿ said Robert Towarnicki, Cell Pathways¿ president and CEO, commenting on the early stock drop. ¿They see we are suspending enrollment and their first reaction is, Uh-oh.¿ We¿ve been pretty volatile anyway ¿ for all I know, we would have been down here without the news or maybe lower. The markets are crazy. But I think as the news is being digested, we¿ve stabilized.¿
Cell Pathways¿ stock (NASDAQ:CLPA) fell to $3.05 following the news Friday ¿ down from Thursday¿s close of $4 ¿ a drop of 95 cents, or about 24 percent. Over the course of the afternoon¿s trading, however, it nickel-and-dimed its way back, ending Friday at $3.50, down 50 cents, or about 12.5 percent.
The surprise wasn¿t the analysis ¿ its occurrence had been established from the get-go ¿ but what caught Wall Street¿s attention was the stoppage of enrollment. Towarnicki said he thought the suspension had, at least in part, to do with the rate that it was accruing patients.
¿This was a preplanned board review, but it was our expectation that we would be able to continue,¿ he said. ¿I think the FDA got nervous with the numbers because we were enrolling so quickly.¿
Cell Pathways, of Horsham, Pa., went from Phase I with Aptosyn in combination with Taxotere to the pivotal trial ¿ perhaps another reason, Towarnicki said, that the FDA wished to halt enrollment until it was able to hear the board¿s recommendation. The board will break the blind on the first 100 patients tested for its review, he said, and added that the company has not seen any adverse events in the trial beyond what is usually seen with patients receiving Taxotere alone. Overall, the trial is scheduled to enroll 600 patients. The trial compares Aptosyn in combination with Taxotere vs. Taxotere alone and the primary endpoint of the scheduled 600-patient trial is increased survival rates of patients both overall and at one year.
Historically, Aptosyn has wreaked havoc on Cell Pathways¿ stock. The company filed a new drug application in August 1999 for Aptosyn to treat familial adenomatous polyposis. On Sept. 25, 2000, the company received a not-approvable letter from the FDA that stated safety and efficacy data were insufficient and highlighted deficiencies in the filing. The Street found this particularly offensive and Cell Pathways¿ stock fell more than $20, or about 69 percent, closing the day at about $9.31. (See BioWorld Today, Sept. 26, 2000.)
Aptosyn for the FAP indication remains shelved. Towarnicki said Cell Pathways is ¿still investigating the feasibility of other clinical trials in FAP¿ and has not dropped it completely. However, the company has shifted its attention, focusing on Aptosyn combination trials instead. Towarnicki said Cell Pathways now has ¿a strong focus on lung cancer, primarily because of our preclinical data.¿
Cell Pathways has 11 open cancer trials: two in prostate, one in breast, one in colon and seven in lung cancer. Most are coupled with a chemotherapeutic agent. It also has the product, CP-461, in early stage cancer trials.
Investors will have a chance to hear more next week, Towarnicki said.
¿We¿ll be presenting at UBS [Warburg Global Life Sciences Conference in New York],¿ he said. ¿They¿ll hear more from me then and hopefully we¿ll see our stock come back some.¿