Incara to Form Partnership With Elan to Develop OP2000; Phase 2/3 Clinical Trial to Start Immediately
RESEARCH TRIANGLE PARK, N.C., Dec. 22 /PRNewswire/ --
Incara Pharmaceuticals Corporation (Nasdaq: INCR - news) announced today that it has entered into a collaborative agreement with Elan Corporation, plc to develop OP2000, its subcutaneously administered ultra-low molecular weight heparin for the treatment of inflammatory bowel disease. Under the terms of the agreement, the companies will pursue the clinical development of OP2000 while utilizing Elan's MEDIPAD® Drug Delivery System.
``We are pleased to enter into this relationship with Elan for OP2000,'' said Clayton I. Duncan, CEO of Incara. ``Their MEDIPAD System has clear potential to enhance the convenience, compliance and safety of OP2000.''
Incara and Elan plan to immediately initiate a Phase 2/3 pivotal clinical study of OP2000 in patients with ulcerative colitis, a form of inflammatory bowel disease. The study will examine the effects of OP2000 in patients receiving standard treatment with aminosalicylates who have developed symptoms of active ulcerative colitis. This initial study will utilize prefilled syringes and deliver OP2000 by subcutaneous injection.
``We were delighted to see strong support for this new treatment strategy for ulcerative colitis at our recent investigators meeting held to kick-off the study,'' stated David P. Ward, M.D., Executive Vice President, Research and Development for Incara. ``In the 28 medical centers committed to participate in this study, we have a good mix of both leading academic research institutions and community hospitals. Our participating physicians seem eager to investigate this new mechanism of action for the treatment of 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.
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's antithrombotic and anti-inflammatory properties, together with data from small clinical studies of unfractionated heparin in patients with inflammatory bowel disease (IBD), provide a rationale for benefit in treatment of patients suffering from ulcerative colitis, a form of IBD. Low molecular weight heparins have been used as replacement for heparin in several other indications.
Incara's OP2000, which is licensed from Opocrin S.p.A., of Modena, Italy for all countries other than Japan and Korea, will be evaluated with Elan's MEDIPAD, a drug delivery technology which combines the convenience of a transdermal patch with the drug delivery capabilities of an infusion pump. The system is disposable, inexpensive and can be used to infuse drugs over up to a 48 hour time frame. Incara and Elan will also provide clinical development, regulatory, project development and business development guidance and, in addition, Elan has made an equity investment in Incara's common and preferred stock. Additional details can be found in Incara's SEC filings.
Inflammatory bowel disease consists of a group of chronic inflammatory disorders of the intestine, of unknown cause, which are characterized by recurrent flares of abdominal pain, cramps, fever, fatigue and diarrhea, with or without bleeding. Two forms of IBD are Crohn's disease and ulcerative colitis. Current treatments of IBD 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. |
