Repligen Corp. on Tuesday started enrolling patients in itsPhase I clinical trial on recombinant platelet factor-4 (rPF4) toevaluate its safety in neutralizing heparin in patientsundergoing cardiac catheterization.

Upon completion of certain cardiovascular procedures,including angioplasty and cardiopulmonary bypass surgery, it'snecessary to reverse the anti-coagulant effects of heparin"before the surgeon can close," explained Sanford Smith,Repligen's president and chief executive officer.

"Currently, surgeons are using protamine, a 15-year-oldproduct with difficult side effects and toxicities that make ithard to handle," he added.

The Cambridge, Mass., company (NASDAQ:RGEN) alsoannounced that it has filed an investigational new drug (IND)application with FDA for Phase I/II studies on using rPF4 intreating various cancers by inhibiting tumor recurrence andmetastases.

Tuesday's filing is actually an extension of the original INDcovering rPF4 and cancer that Repligen submitted in January,said Smith. That study -- on colon carcinoma -- is scheduled tobegin "in the near future," Smith told BioWorld.

The extensions, which cover malignant melanoma and renal cellcarcinoma, employ different protocols. "We hope to have allthree Phase I/II probe studies running in the second half ofthe year," Smith said.

Repligen has already completed a Phase I study of rPF4 inpatients with Kaposi's sarcoma (KS), and is planning a PhaseI/II trial. The data from the first KS study will be presented atthe American Society of Clinical Oncology (ASCO) meeting inMay, Smith told BioWorld.

-- Jennifer Van Brunt Senior Editor

(c) 1997 American Health Consultants. All rights reserved.