AtheroGenics Commences Phase I Trial for Novel Drug AGI-1096 For the Prevention of Organ Transplant Rejection
ATLANTA, March 5 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - news), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced that it has begun a Phase I clinical trial of AGI-1096 as an oral treatment for the prevention of organ transplant rejection. The Phase I trial is designed to assess the safety and tolerability of AGI-1096 in healthy volunteers. The study is being conducted in the U.S. under an investigational new drug application with the U.S. Food and Drug Administration.
AGI-1096 is a novel antioxidant and selective anti-inflammatory agent derived from the AtheroGenics v-protectant technology platform. AGI-1096 inhibits the expression of certain inflammatory proteins, including VCAM-1, in endothelial cells lining the inside surfaces of blood vessel walls. AGI-1096 may prevent transplant rejection in two ways -- first, by diminishing the transplant response to inflammation and second, by protecting the blood vessels to the transplanted organ through its v-protectant activity.
``The current therapeutic regimen for transplant recipients involves the daily use of powerful drugs called immunosuppressants. This course of therapy, while necessary, may also increase the risk of infection and illness since the body's natural defenses are lowered to prevent an immune response. AGI-1096 works in a unique fashion to target the accelerated vascular inflammation underlying chronic organ rejection,'' said Russell Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. ``If successfully developed, AGI-1096 may be a particularly appropriate therapy for addressing this critical unmet medical need while also potentially providing a unique complementary therapy to immunosuppressants.''
Organ transplantation takes place when an organ from a donor is surgically removed and placed into a recipient patient whose own organ has failed because of disease or infection. Nearly all transplant patients will experience one or more episodes of rejection during their recovery period. Chronic rejection occurs either because the organ recipient's immune system, during the course of months or years, comes to recognize the transplant as ``foreign,'' or because the blood supply to the transplant becomes blocked due to an accelerated closure (inflammation) of the blood vessels leading to the transplanted organ. Chronic rejection is a major factor contributing to transplant organ shortage. Industry sources report there are over 200,000 organ transplant recipients in the United States who are at risk of chronic transplant rejection.
Current therapy for transplant rejection involves utilizing a regimen of immunosuppressants, including cyclosporin A, tacrolimus, and rapamycin (sirolimus). However, the Scientific Registry of Transplant Rejection reports that, even with the use of immunosuppressants, patients have a 20 to 50 percent risk of rejecting a donated organ during the first three years following transplantation, and less than 50 percent of patients have functioning grafts after approximately 10 years. Additionally, chronic use of immunosuppressants can lead to impairment of the graft recipients' immune system |
