INCR (Naz 1.80) more:
Human Liver Precursor Cell Transplant
Incara established its liver precursor cell program with the acquisition of a majority ownership interest in Renaissance Cell Technologies, Inc. in September 1997. The Company is now scaling-up the liver precursor cell isolation and selection process to produce the cells required for clinical trials. This step includes establishing isolation and processing procedures needed for a 1,500-gram to 3,000-gram whole human liver instead of the 100-gram portions of liver used in the basic research stage of the program. The scaled-up procedures are being adapted for a sterile good manufacturing practices, or cGMP, environment. After scale-up, the Company expects to transfer the liver precursor cell processing procedure to a contract cell processor with a facility compliant with cGMP to produce cells suitable for use in clinical trials.
Incara's liver precursor cell technology has application in the development of a liver assist device, or LAD. For seven to thirty days, a LAD provides liver function to allow a patient's own liver to recover from failure or to provide a bridge to transplant. Incara's LAD is expected to be an artificial liver composed of human liver cells in a device through which the patient's blood or plasma is circulated.
Attempts at clinically useful LADs by others have utilized pig hepatocytes or human liver cells derived from tumors in a wide variety of bioreactor types. These devices have shown promise, but all use cells with limitations that the Company's LAD is designed to overcome. The pig hepatocytes, while easily obtained, have severe limitations such as potential immune reactions to secreted pig proteins, limited lifetime and non-human viruses. The liver cells derived from tumor cells are easy to grow, but retain only a subset of the functions of normal liver cells and involve safety concerns. Functioning human liver cells from donor organs have not been an alternative due to the scarcity of donor livers.
Incara Announces Issuance of Additional Patent For Isolating Liver Progenitor Cells
RESEARCH TRIANGLE PARK, N.C., June 12 /PRNewswire/ --
Incara Pharmaceuticals Corporation (Nasdaq: INCR - news) announced the issuance from the United States Patent and Trademark Office of patent number 6,242,252 entitled ``Hepatic progenitors and methods of isolating same.'' Hepatic progenitors, which include liver stem cells, are potentially capable of extensive growth and of maturing into functioning liver tissue. The patent is a result of research led by Dr. Lola M. Reid, currently at the University of North Carolina, and is licensed to Incara.
``This patent adds to our growing intellectual property portfolio in the field of liver stem and progenitor cells, and their isolation and use,'' stated Clayton I. Duncan, President and CEO of Incara. ``This is our fifth U.S. patent to issue from Dr. Reid's work in the field and six more U.S. patent applications have been submitted.''
Incara intends to isolate living precursor cells from livers now considered inappropriate for whole organ transplantation. The company plans to file an IND with the FDA in late 2001 to begin Phase 1 human clinical trials investigating the transplantation of these cells as a treatment for patients suffering from chronic liver failure and for children with certain inherited liver diseases. It is hoped that treating patients with liver precursor cells might eventually reduce the need for transplant of whole donor livers, which are in short supply.
In the United States, there are an estimated 330,000 hospitalizations per year for chronic liver diseases and 30,000 deaths. Liver transplant is a cure for many of these liver diseases, but only about 4,900 donor livers appropriate for transplant become available each year and there are over 17,500 patients on the liver transplant waiting list.
Incara Pharmaceuticals Corporation is developing therapies focused on tissue protection, repair and regeneration. The company currently has research and development programs in three areas: liver progenitor cell therapy as a treatment for liver failure; catalytic antioxidants as treatment for stroke and prevention of radiation-induced side effects from cancer therapy; and OP2000, an ultra-low molecular weight heparin being developed with Elan Corporation for treatment of ulcerative colitis. Dr. Reid is the scientific founder of Incara's liver stem cell program and a Professor at the University of North Carolina at Chapel Hill School of Medicine. Additional background information regarding this program and Incara's other programs is available on the company's website at www.incara.com. |
