Scios Nova Inc. announced Tuesday that it has begun amulticenter Phase III clinical trial of Auriculin -- atrialnatriuretic peptide (ANP) -- for treating acute kidney failure.Auriculin is generally regarded as the Mountain View, Calif.,company's lead product.
The study will be conducted at 35 centers and will include 500patients, treated on a one-time basis in a hospital setting. "Weare targeting people who have developed acute renal failure inresponse to a specific insult, usually an ischemic insult wherethe kidney is not getting enough blood flow (as in trauma andseptic shock)," explained Robin Allgren, associate medicaldirector of Scios Nova (NASDAQ:SCIO).
The hormone ANP, although produced by the heart, influenceskidney function, as well. It increases the elimination of waterand salt from the body, dilates the blood vessels, and decreasesthe secretion of other hormones that lead to blood vesselconstriction and elevated blood pressure.
The Phase II clinical studies on Auriculin included trials in bothacute kidney failure and radiocontrast dye-induced kidneydamage. About 300 to 400 patients participated in these trials,said Virginia Walker, Scios Nova's chief financial officer. Shesaid that the company chose to pursue the acute kidney failureindication for its Phase IIIs because "it's a larger market,where the drug will have more impact." And currently there'sno approved treatment for acute renal failure, nor is there anyother compound in clinical trials for this indication, Allgren toldBioWorld.
Scios Nova scientists have cloned the gene for human ANP, andproduce it both synthetically and via recombinant DNAtechnology. The company is using the synthetic version in itshuman clinical trials, and "plans to complete Phase IIIs andinitiate market launch with the synthetic material," Allgrentold BioWorld. ANP is 25 amino acids long and "not hard tosynthesize," Allgren said.
Scios Nova holds worldwide rights to Auriculin, which iscovered by a U.S. patent. Auriculin also received orphan drugstatus from the FDA this year for treating acute kidney failure,which affects about 160,000 annually in the U.S.
According to Cowen & Co. analyst David Stone, the U.S. marketis worth about $250 million a year. Scios Nova's Walker addedthat a course of therapy is predicted to cost about $2,000.
The company's stock rose 50 cents a share on Tuesday, closingat $9.25.
-- Jennifer Van Brunt Senior Editor
(c) 1997 American Health Consultants. All rights reserved.