Incara Receives Orphan Drug Designation for ALS Drug Candidate
11 November 2003 - 12:41AM
PR Newswire (US)
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/
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