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Incara Receives Orphan Drug Designation for ALS Drug Candidate
RESEARCH TRIANGLE PARK, N.C., Nov. 10 /PRNewswire-FirstCall/ -- Incara
Pharmaceuticals Corporation (BULLETIN BOARD: INCR) announced today that the
Food and Drug Administration has granted orphan drug designation to its drug
candidate for the treatment of amyotrophic lateral sclerosis (ALS, also known as
Lou Gehrig's disease). Orphan drug designation can be granted by the FDA for
treatments that might provide significant benefit to patients with serious,
life-threatening diseases that affect less than 200,000 persons in the United
States.
The Orphan Drug Act was created by Congress to provide assistance and incentives
for sponsors to develop drugs judged to be of potential benefit for a qualifying
disease. Orphan drug designation qualifies a product for possible funding to
support clinical trials, study design assistance from the FDA during development
and for financial incentives, including seven years of marketing exclusivity
upon FDA approval. In addition to market exclusivity, orphan drug status
provides possible tax incentives for a company's investment in U.S. clinical
research.
"We are pleased that the FDA found our pre-clinical data and rationale for
developing AEOL 10150 as a potential treatment of ALS sufficient to grant orphan
drug designation at this stage of development," said Richard E. Gammans, Ph.D.,
Executive Vice President, Research and Development, of Incara. "We will continue
to work with them to advance this product to clinical testing in ALS patients as
quickly as possible."
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 components of its recently announced financing, Incara intends to file
an IND application for the treatment of ALS 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 models of 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
period of the control group. AEOL 10150-treated mice, in addition to surviving
longer, remained only mildly disabled until a few days before death. Mice in
the control group experienced increased disability daily. Data from these
experiments can be viewed at Incara's website http://www.incara.com/ .
Incara Pharmaceuticals Corporation is developing a new class of small molecule
catalytic antioxidants that destroy oxygen-derived free radicals, believed to be
important contributors to the pathogenesis of many diseases. In addition to ALS
(Lou Gehrig's disease), Incara's catalytic antioxidants have been shown to
reduce damage to tissue in animal studies of neurological disorders such as
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
clinical trials, product development activities and scientific research and the
need to conserve and obtain funds for 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.
DATASOURCE: Incara Pharmaceuticals Corporation
CONTACT: W. Bennett Love of Incara Pharmaceuticals Corporation,
+1-919-558-1907
Web site: http://www.incara.com/