By Mary Welch

Phase II data showed that ReoPro, Centocor Inc.'s approved anti-platelet drug, improved clinical function in patients with acute ischemic stroke without an increase in intracranial bleeding up to 24 hours after symptom onset.

"This study was done in a small number of patients and we will use this study to kick off a later Phase II study that will be started next year to confirm the results before starting a Phase III," said Christopher Allman, spokesman for Malvern, Pa.-based Centocor.

The trial involved 74 patients with acute ischemic stroke who were followed for three months. At study entry, about half were in the midst of a severe stroke. Patients were treated with placebo or one of four doses of ReoPro. Three months after treatment, 35 percent of the patients who took any dosage of ReoPro had minimal or no residual disability, compared with 20 percent who received placebo. In addition, 50 percent of the patients treated with ReoPro showed improved function in carrying out daily activities compared with 40 percent of placebo patients. There also was a trend toward improved neurological functioning with ReoPro therapy.

In other ReoPro news, Duke University Medical Center said using ReoPro with reteplase, a drug that breaks up clots, was preferable to using clot-busting drugs or angioplasty alone. Reteplase is marketed by Centocor under the name Retavase.

The strategy - dubbed "facilitated angioplasty" - involves giving patients a quick cocktail of drugs to dissolve clots and stop them from re-forming and, an hour later, performing an angioplasty to clear plaque from the now-opened heart arteries.

The trial, called SPEED (Strategies for Patency Enhancement in the Emergency Department), involved 528 patients. However, the results of an analysis of 323 patients showed promise, Allman said.

Thirty days after the heart attack, 5.6 percent of the patients who had facilitated angioplasty had either died, had another heart attack or had an urgent procedure to reopen the artery, compared with 16 percent who did not have facilitated angioplasty.

The rate of clinical success - defined as survival and freedom from another heart attack, an urgent cardiac procedure and bleeding - was 85 percent in the facilitated-angioplasty group and 70 percent for other patients.

ReoPro is a dual receptor glycoprotein IIb/IIIa and alpha V beta 3 antagonist. The drug is jointly marketed in the U.S. by Centocor and Eli Lilly and Co., of Indianapolis.

The research was presented at the American Heart Association's meeting in Atlanta. In other meeting news:

¿ Collateral Therapeutics Inc., of San Diego, said its researchers have constructed a recombinant adenovirus expressing both fibroblast growth factor and vascular endothelial growth factor for the potential commercial development of non-surgical gene therapy products for the treatment of cardiovascular diseases. Preliminary data show the dual recombinant gene is biologically active and is associated with a favorable treatment effect in an animal model of coronary artery disease, the company said.

¿ COR Therapeutics Inc., of South San Francisco, said its oral GP IIb/IIIa inhibitor, cromafiban, demonstrated distinct pharmacologic differences to other agents in the class and showed predictable and consistent inhibition of platelet aggregation at both single-dose and multiple-dose levels in a Phase II trial. Results from the trials showed little variability between peak and depressed levels of platelet aggregation inhibition. Mild bleeding was the most prevalent complication. Phase III trials are expected to start in the latter half of next year, the company said.