RESEARCH TRIANGLE PARK, N.C., April 26 /PRNewswire-FirstCall/ -- Incara Pharmaceuticals Corporation (BULLETIN BOARD: ICRA ) announced the presentation of results for its catalytic antioxidant compound, AEOL 10150, in a preclinical model of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). John P. Crow, Ph.D., Professor of Pharmacology and Toxicology at the University of Arkansas College of Medicine, who conducted the experiments, was invited to present the results Sunday, April 25 in San Francisco at the 56th Annual Meeting of the American Academy of Neurology.
Dr. Crow summarized four separate studies in a transgenic mouse model of ALS, conducted in two academic medical centers over an 18-month period. On an aggregated basis the survival time period after symptom onset for the AEOL 10150-treated group of mice was three times the survival period of the untreated group. (survival interval ratio = 2.98, p<0.01) In an additional study arm, AEOL 10150 was combined with creatine plus rofecoxib (a cox-2 inhibitor), a mixture that has shown a beneficial effect in this model, and then compared to treatment with creatine plus rofecoxib alone and compared with untreated control animals. The creatine plus rofecoxib treated animals yielded a survival interval ratio of 1.42 compared to untreated animals. Animals treated with AEOL 10150 in addition to creatine and rofecoxib showed a further doubling in survival time compared with those treated with creatine and rofecoxib alone (survival interval ratio versus control = 2.90, p<0.01).
"It is an honor for the preclinical data on our compound to be accepted for a platform presentation at the Annual Meeting of the American Academy of Neurology," stated Clayton I. Duncan, Chairman and CEO of Incara. "We are pleased with the interest in our compound from the neurology community here. This meeting represents a welcomed opportunity for us to meet with medical leaders in the ALS field prior to our submitting an IND."
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. Incara is in final preparation of an Investigational New Drug (IND) application to be filed with the FDA for treatment of ALS. Allowance of the IND by the FDA would permit Incara to initiate clinical trials. If the results of Phase 1 clinical trials are satisfactory, Incara's clinical plan calls for initiating a Phase 2/3 clinical trial of AEOL 10150 for treatment of ALS as early as the first half of 2005.
Incara Pharmaceuticals Corporation is developing a new class of small molecule catalytic antioxidants that destroy oxygen-derived free radicals, believed to be an important contributor to the pathogenesis of many diseases. Incara's catalytic antioxidants have been shown to reduce damage to tissue in animal studies of neurological disorders such as ALS and stroke, and in other non-neurological indications such as cancer radiation therapy, chronic bronchitis and asthma.
The statements in this press release that are not purely statements of historical fact are forward-looking statements, and actual results might differ materially from those anticipated. These statements and other statements made elsewhere by Incara or its representatives, which are identified or qualified by words such as "intends," "likely," "will," "suggests," "expects," "might," "may," "believe," "could," "should," "would," "anticipates," "plans," or the negative of those terms or similar expressions, are based on a number of assumptions that are subject to risks and uncertainties. Important factors that could cause results to differ include risks associated with the uncertainties of scientific research, clinical trials and product development activities and the need to obtain funds for clinical trials and operations. These and other important risks are described in Incara's reports on Form 10-K, Form 10-Q and Form 8-K and its registration statements filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Incara assumes no obligation to update the information in this release.
Incara Pharmaceuticals Corporation