Scios Inc. began a multi-center Phase III study of Natrecor BNP, anaturally occurring hormone, to treat acute congestive heart failure, acondition that affects an estimated 4 million people a year and killsup to 600,000 of them.
BNP, or b-type natriuretic peptide, is found in elevated levels ofcongestive heart failure patients and is believed to be produced by thebody to help revive a faltering heart.
Robin Allgren, senior director of clinical research for MountainView, Calif.-based Scios, said in patients with congestive heartfailure, the organ has become big and flabby, has too much fluid andcannot circulate blood effectively. In acute conditions people arefatigued and short of breath.
BNP, Allgren noted, dilates blood vessels leading into and out of theheart to improve its pumping action. The hormone also has beenfound to boost elimination of salt and fluids and decrease bloodvessel constriction.
Current treatments for acute congestive heart failure involve multipledrugs to lower fluid volume, open blood vessels and speed up heartrate.
The Phase III trial of Natrecor will be conducted in two parallelsegments involving more than 300 patients at about 50 medicalcenters throughout the U.S.
One study will enroll 120 patients in a placebo-controlled trial todetermine Natrecor's efficacy in support of filing a new drugapplication (NDA) with the FDA for use of the hormone as a short-term treatment for acute congestive heart failure.
Patients entering the hospital will receive one of two doses ofNatrecor or a placebo in the first six hours of treatment to evaluatethe drug's ability to improve cardiac performance and stabilize thepatient.
After six hours patients on placebo will begin standard multiple drugtreatments. Those who were given Natrecor will continue to receiveinfusions for 24 hours. The patients subsequently will be followed for21 days to monitor heart function and the need for additional therapy.Results of the study are expected in the second half of 1997.
The second segment of the trial will be an open-label evaluation ofNatrecor, enrolling more than 200 acute congestive heart failurepatients. Natrecor will be administered along with standard drugs toadd to the clinical evidence of its effectiveness. That study also isscheduled to be complete by the second half of 1997.
Scios expects to file an NDA for Natrecor by the end of 1997 orbeginning of 1998. The company intends to market a recombinanthormone, rather than a synthetic form of the peptide.
Earlier this year preliminary analysis of Phase II studies of Natrecorshowed patients experienced continued improvement in heartfunction over the course of 24 hours of treatment with the drug.
Scios intends to sell Natrecor itself in the U.S., but it is seeking amarketing partner for Europe and Japan.
Scios' stock (NASDAQ:SCIO) closed Thursday at $6, up $0.25. n
-- Charles Craig
(c) 1997 American Health Consultants. All rights reserved.