PR Newswire
08/08/03, 8:23a
(Copyright © 2003, PR Newswire)

RESEARCH TRIANGLE PARK, N.C., Aug. 8 /PRNewswire-FirstCall/ -- Incara Pharmaceuticals Corporation (OTC Bulletin Board: INCR) announced today the selection of its catalytic antioxidant, AEOL 10150, for late-stage preclinical development to support an Investigational New Drug (IND) application for the treatment of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). ALS, the most common motor neuron disease, results from progressive degeneration of both upper and lower motor neurons and is usually fatal within 5 years. Assuming satisfactory completion of animal safety studies, and completion of the remaining component of its recently announced financing, Incara intends to file the IND application in the second quarter of 2004. Allowance of the IND by the FDA would permit Incara to initiate clinical trials. The clinical program will test the ability of AEOL 10150 treatment to extend the survival of ALS patients.

Incara's catalytic antioxidant compound, AEOL 10150, has demonstrated efficacy in an animal model of ALS, and other neurodegenerative diseases. In recent experiments in a transgenic mouse model of ALS, the survival time period after symptom onset for the AEOL 10150-treated group was 2.5 times the survival time period of the control group. Mice in the control group experienced increased disability daily. In additional to surviving longer, AEOL 10150-treated mice remained only mildly disabled until a few days before death. Data from these experiments can be viewed at Incara's website www.incara.com .

"These results are noteworthy in that drug administration (to experimental animals) was begun after onset of muscle weakness, comparable to the earliest time point when treatment of human patients could begin," stated John P. Crow, Ph.D., Professor of Pharmacology and Toxicology at the University of Arkansas for Medical Sciences, who conducted the recent experiments. "In virtually all other studies in ALS mice to date, animals were pretreated with a drug well before they began showing symptoms of disease -- something which cannot be done with human patients. AEOL 10150 showed the largest survival increase that has been reported for a drug therapy following symptom onset in the ALS model. Not only was survival enhanced, but AEOL 10150 also preserved near- normal motor function until one to two days prior to death."

"In addition to potentially filling an important medical need, a positive effect on ALS progression would suggest utility of our catalytic antioxidants in other progressive neurodegenerative diseases, such as Alzheimer's disease," said Richard E. Gammans, Ph.D., Executive Vice President, Research and Development, of Incara.

Incara recently closed on a bridge loan facility of $3 million. The company also signed a nonbinding letter of intent for an additional $5 million in funding, subject to satisfactory completion of a toxicology study and other conditions. Completion of these financings is expected to provide sufficient funds to complete one or more Phase 1 clinical trials for AEOL 10150.

Incara Pharmaceuticals Corporation is focused on a new class of disease- modifying small molecules, the catalytic antioxidants. Oxygen derived free radicals are a common step in neuronal death resulting from a variety of causes. Incara's catalytic antioxidants have been shown to reduce damage to tissue in animal studies of neurological disorders such as amyotrophic lateral sclerosis (Lou Gehrig's disease) and stroke, and in other non-neurological indications such as cancer radiation therapy, chronic bronchitis and asthma. After six years of preclinical research, Incara has completed pharmacology studies, selected a first indication for clinical development, conducted preliminary dose ranging toxicology studies and completed scale-up synthesis of its lead molecule.