Incara Submits IND for Liver Cell Transplantation
RESEARCH TRIANGLE PARK, N.C., June 28 /PRNewswire-FirstCall/ --
Incara Pharmaceuticals Corporation (Nasdaq: INCR - News) today submitted an Investigational New Drug Application (IND) with the Food and Drug Administration to begin Phase 1 clinical trials of human liver cells for the treatment of patients with cirrhosis and end-stage liver disease. Chronic liver disease leads to approximately 300,000 hospitalizations and 30,000 deaths each year in the United States. Liver cell transplantation is an experimental procedure in which a physician injects a suspension of donor liver cells into the blood vessels leading to a patient's liver or spleen in a minimally invasive procedure. The injected cells are expected to create new functioning liver tissue, which could improve symptoms, extend the time a patient can live without a liver transplant or possibly eliminate the need for a liver transplant entirely.
"Our IND for a cryopreserved human liver cell transplantation product advances the new era of regenerative medicine one step closer to the patient," said Clayton I. Duncan, President and CEO of Incara. "Successful development of this program could open up treatment to a large group of seriously ill patients who now have few alternatives."
Initial preliminary human clinical trials of liver cell transplantation by academic investigators outside of Incara have shown improvement of liver function in some patients with liver failure. Over 50 patients have been given this experimental procedure to date. Incara believes that for liver cell transplantation to become a conventional therapeutic procedure and a viable treatment option for a significant number of patients, a commercial program must be established to demonstrate clinical efficacy and safety with a well defined, consistently produced product.
Incara's liver cell transplantation product is a well-characterized mixture of cryopreserved human liver cells that are obtained from the livers of organ donors that are not suitable for whole organ transplant. Incara's strategy is to create a product that can be shipped overnight to clinical sites where it will be thawed, diluted and infused into the patient. One donor liver may provide sufficient numbers of liver cells for multiple recipients.
The NIH estimates that at least four million people in the United States have been infected with hepatitis C and expects the incidence of chronic liver disease to increase over the next ten years as a result. Although decades of research have led to better understanding of diseases that affect the liver, the only cure for many of these diseases is a liver transplant. There is a severe shortage of donor livers available for transplant. Only approximately 5,000 donor livers are available annually in the United States and approximately 17,500 people are on the liver transplant waiting list. Incara estimates approximately 100,000 individuals in the United States have signs of severe chronic liver disease and could become candidates for a liver transplant.
Incara Pharmaceuticals Corporation (www.incara.com) is focused on disease therapies based on tissue protection, repair and regeneration. The company is developing cell therapy for treatment of liver failure and in addition is investigating the use of liver stem cells. Incara is also developing a series of catalytic antioxidants as treatments for protection of cells from damage occurring in stroke and cancer radiation therapy, and for protection of cells from transplant rejection. In addition, Incara is conducting a Phase 2/3 multicenter clinical trial for deligoparin, an ultra-low molecular weight heparin being developed with Elan Corporation for treatment of ulcerative colitis. Results of this pivotal trial should be available around March 2003. |
