Tuesday January 30, 8:25 am Eastern Time
Press Release
SOURCE: Incara Pharmaceuticals Corporation
Incara Initiates Phase 2/3 Clinical Trial for OP2000
RESEARCH TRIANGLE PARK, N.C., Jan. 30 /PRNewswire/ --
Incara Pharmaceuticals Corporation (Nasdaq: INCR - news) announces that patients are now being enrolled and treated in a
pivotal Phase 2/3 study of OP2000 in patients with ulcerative colitis. OP2000 is a subcutaneously administered ultra-low
molecular weight heparin being developed by Incara and Elan Corporation, plc. The study will examine the effects of OP2000
in patients receiving standard treatment with aminosalicylates who have developed symptoms of active ulcerative colitis.
``Many ulcerative colitis patients respond poorly to current treatments and are in need of effective new therapies,'' stated David
P. Ward, M.D., Executive Vice President, Research and Development for Incara. ``We are excited to begin this large clinical
trial of OP2000, which has pharmacological properties very different from currently approved drugs for ulcerative colitis.''
The study is designed to enroll approximately 270 patients with symptoms of active ulcerative colitis. Patients will be treated
with drug or placebo once a day for six weeks. The objective of treatment will be to cause complete remission or significantly
improve the signs and symptoms of ulcerative colitis. If the results of this trial are positive, the trial is expected to serve as one
of two pivotal safety and efficacy trials required for approval.
OP2000 is derived from heparin by chemically breaking it down into smaller fractions. These smaller fractions of heparin have
lower molecular weight and may prove to have advantages over heparin, including better safety, efficacy and reduced
requirement for laboratory monitoring of effects. In studies of over 230 healthy subjects and patients with cardiovascular
disease, OP2000 has been shown to be safe and well tolerated.
OP2000 is being developed by Incara Development, Ltd., which is jointly owned by Incara Pharmaceuticals and Elan. The
product is licensed by Incara from Opocrin S.p.A., of Modena, Italy for all countries other than Japan and Korea.
Ulcerative colitis is a chronic inflammatory disorder of the large intestine, of unknown cause, which is characterized by recurrent
flares of abdominal pain, cramps, fever, fatigue, diarrhea and bleeding. Current treatments of ulcerative colitis are designed to
reduce inflammation and relieve symptoms in addition to replacing lost fluids and nutrients. These include treatment with
corticosteroids and aminosalicylates, often with unsatisfactory results. In serious cases, surgery may be required.
Incara Pharmaceuticals Corporation (www.incara.com) is developing a diversified portfolio of proprietary therapies oriented to
treatment of diseases afflicting large patient populations. In addition to OP2000, the Company's current programs include liver
stem and precursor cell therapy for the treatment of liver failure, and small molecule catalytic antioxidants for treatment of
stroke and cardiac reperfusion injury.
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 the Company
or its representatives, which are identified or qualified by words such as ``intends,'' ``likely,'' ``will,'' ``suggests,'' ``expects,''
``might,'' ``may,'' ``believe,'' ``could,'' ``should,'' ``would,'' ``anticipates,'' or ``plans,'' 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 need to obtain funds for operations, uncertainties of scientific research, clinical trials and product
development activities. These and other important risks are described in Incara's most recent registration statement on Form
S-1 and its reports on Form 10-K, Form 10-Q and Form 8-K 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. The
Company assumes no obligation to update the information in this release.
SOURCE: Incara Pharmaceuticals Corporation |
