Incara IND for Liver Cell Transplantation Allowed by FDA
RESEARCH TRIANGLE PARK, N.C., July 30 /PRNewswire-FirstCall/ --
Incara Pharmaceuticals Corporation (Nasdaq: INCR - News) today announced it has been notified by the Food and Drug Administration (FDA) of their allowance of Incara's Investigational New Drug Application (IND) to begin Phase 1 clinical trials of cryopreserved human liver cells for the treatment of patients with cirrhosis and end-stage liver disease. Assuming adequate financial resources, the company intends to initiate clinical trials this fall.
"Allowance of our IND for liver cell therapy by the FDA is a tribute to the quality of the work performed by Incara's development team. Developing a pharmaceutical grade cell therapy product is a difficult task that applies the traditional pharmaceutical industry skills of scale-up manufacturing, preclinical pharmacology and toxicology, and clinical trial design to the new discipline of regenerative medicine," said Clayton I. Duncan, President and CEO of Incara.
"The clinical trial program will target patients with cirrhosis and end- stage liver disease whose severity is such that the patients would be candidates for placement on a whole liver transplant waiting list," stated David P. Ward, M.D., Executive Vice President, Research and Development of Incara. "The goal of our therapy will be to improve the quality of life of these patients, delay a whole liver transplant or even avoid the need of a whole liver transplant. In the initial clinical trial, a subset of this patient population, those with limited options, will be studied. These patients will have coexisting cardiac, pulmonary or other medical conditions that make them ineligible for whole liver transplantation. Assuming the initial clinical trial demonstrates safety and bioactivity, Incara plans to evaluate the cells in a broader range of patients in later clinical trials."
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.
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.
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. |
