Five months after Scios Nova Inc. said that Auriculin didnot achieve its two primary clinical endpoints in a PhaseIII study for the treatment of acute renal failure (ARF),the company has re-focused the clinical trials on asubgroup of patients with oliguric acute renal failure.

Scios Nova said Tuesday that it is enrolling patients in aPhase III clinical trial that will eventually includeapproximately 250 patients. Testing will be conducted atabout 50 to 60 centers in the U.S. and Canada.

In the earlier clinical trial, Auriculin did not reduce theneed for dialysis nor did it reduce mortality in a 504-patient placebo-controlled Phase III study. However, asubsequent analysis of the data showed the drug had astatistically significant effect on those patients witholiguric ARF, or abnormally low urine output, KiraBacon, director of investor relations for Scios Nova toldBioWorld Today.

When news of the company's lead product was releasedin May, Scios Nova's stock dropped 40 percent. (SeeBioWorld Today, May 4, 1995, p. 1.) On Tuesday itsstock (NASDAQ:SCIO) was up 6 cents to close at $3.94.

The clinical end point of the current trial is dialysis-freesurvival. The study also will evaluate the number ofoliguric ARF patients requiring acute dialysis at 14 daysand patient mortality at 21 days. The trial is expected tobe completed within 24 months.

Scios Nova estimates that 20 to 50 percent of the 160,000patients diagnosed with ARF annually are oliguric. Notreatment currently is available.

Scios Nova's announcement came as no surprise toFelicia Reed, analyst with Cowen & Co., of Boston. "Wehave been saying for some time that once Scios sat downwith the FDA and Genentech Inc. they would see thatanother study was needed. Now it will be another twoyears before the drug is ready," she said.

Earlier results from clinical studies of Auriculin werepromising enough to attract South San Francisco-basedGenentech to sign a commercialization deal worth up to$100 million. The agreement, inked last January, gaveScios Nova U.S. marketing rights to Auriculin whileGenentech was granted worldwide rights outside of thecountry.

Auriculin is an atrial natriuretic peptide produced by theheart that has important effects on heart and kidneyfunction, including increasing the elimination of waterand salt from the body. Scios Nova also has underdevelopment Natrecor for the treatment of acutecongestive heart failure. n

-- Michele L. Robinson Washington Editor

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