By Mary Welch
Scios Inc. disclosed a Phase II/III trial for Fiblast (trafermin) in acute stroke was temporarily suspended by an independent Data and Safety Monitoring Committee after examining available findings from about half of the 900 patients enrolled.
"We were surprised but not totally surprised," said Mary Ann Allencourt, manager of investor relations for Mountain View, Calif.-based Scios. The company is jointly developing the drug with Wyeth-Ayerst Laboratories, the Radnor, Pa., pharmaceutical arm of American Home Products Corp., of Madison, N.J.
Wyeth-Ayerst paid up to $12 million in cash and agreed to ante up another $32 million upon achieving certain milestones as part of a deal to jointly develop and market Scios' Fiblast. (See BioWorld Today, Oct. 25, 1996, p. 1.)
Scios' stock (NASDAQ:SCIO) closed Tuesday at $10.875, down $1.687, a 13.6 percent decrease.
The trial suspension will allow the independent committee to review data from all patients enrolled in sites throughout the country. The committee estimated it will take at least a couple of months to review the data.
"We don't have a wealth of information about the suspension," said Allencourt. "It was a regularly scheduled interim look. The committee said it wanted to look at the data from the total number of people available and they were suspending the trial until the data was gathered."
Wyeth-Ayerst also was confused by the action. "We don't know why. We'll just wait and see what will happen," said Douglas Petkus, a Wyeth-Ayerst spokesman.
Allencourt said that, as a rule, trials done with stroke victims are "generally difficult."
Fiblast is a recombinant form of basic fibroblast growth factor (bFGF), a naturally occurring peptide with neuroprotective and angiogenic properties. It has been shown to protect neurons from the damaging effects of stroke, including oxygen and glucose deprivation. In preclinical animal trials, it significantly reduced the amount of damaged tissue from a stroke.
Other Trials On Schedule
Fiblast will enter Phase II trials this year in the additional indications of peripheral vascular disease and coronary artery disease.
Also, a 900-patient Phase II/III study in acute stroke is being conducted in Europe. "The trial is going on in Europe, although at slightly behind the U.S. schedule," said Allencourt. "The reviewing committee in Europe, of course, is separate from the one in the U.S., but it is aware of the actions taken here."
The study's end points are admittedly fuzzy. Patients must be admitted within six hours of actually having a stroke. Fiblast is introduced intravenously to prevent further damage.
"Obviously, the problem is that you don't know how much damage would have taken place," Allencourt said. "You don't know what the blood pressure would have been if a patient didn't receive Fiblast. You don't know how much tissue damage there would have been. There's no way to get a hard reading."
As to the future of Fiblast for acute stroke victims, Allencourt would only say, "It's far too premature to guess, and it's not wise to speculate." *