Future in Transplantation -5

AtheroGenics Announces Collaboration with Fujisawa to Develop AGI-1096 for Transplant Rejection  ATLANTA, Jan. 12 /PRNewswire-FirstCall/ -- AtheroGenics, Inc. (Nasdaq: AGIX - News), a pharmaceutical company , today announced a collaboration with Fujisawa Pharmaceutical Co., Ltd., to develop AtheroGenics' novel compound, AGI-1096, as an oral treatment for the prevention of organ transplant rejection.The collaboration will leverage AtheroGeni cs' expertise in discovering innovative treatments for chronic inflammation with Fujisawa's world-class experience in transplant rejection therapies. Under the agreement, AtheroGenics and Fujisawa will collaborate to conduct preclinical and early stage clinical development trials, with Fujisawa funding all development costs during the term of the agreement. Fujisawa will also receive an option to negotiate for late stage development and commercial rights to the compound."This collaboration accomplishes our goal of creating a partnership with a world-class pharmaceutical company to develop this novel drug therapy for treating organ transplant rejection," commented Russell M. Medford, M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. "Fujisawa's leadership position in developing and marketing therapies for the management of transplant rejection makes it an ideal partner for AtheroGenics as we move AGI-1096 forward in clinical trials.""Our collaboration with AtheroGenics underscores Fujisawa's continued commitment to identify novel therapies in the area of transplant rejection," said William E. Fitzsimmons, Pharm.D., M.S., Senior Global Project Leader, Transplantation at Fujisawa. "We are very pleased to be working with AtheroGenics to determine the potential of AGI-1096 and its possible use in patients after organ transplantation."AGI-1096 is a selective anti-inflammatory agent that is being developed to address the accelerated inflammation in chronic organ transplant rejection. The Company completed a Phase I clinical trial, which demonstrated that AGI- 1096 was safe and well-tolerated over the escalating single oral doses studied. Subjects reached targeted blood levels of AGI-1096 that were equivalent to those seen in successful pre-clinical models of organ transplant rejection.Long-term organ 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 of the blood vessels leading to the transplanted organ. Chronic rejection is a major cause of organ failure after transplantation. Industry sources report there are over 150,000 organ transplant recipients in the U.S. who are at risk of chronic transplant rejection.About AtheroGenicsAtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including heart disease (atherosclerosis), rheumatoid arthritis and asthma. The Company has four drug development programs in the clinic. AtheroGenics' lead compound, AGI-1067, is being evaluated in the pivotal Phase III clinical trial called ARISE (Aggressive Reduction of Inflammation Stops Events) as an oral therapy for the treatment of atherosclerosis. AGIX-4207, the Company's second clinical compound derived from its proprietary v- protectant(TM) technology platform, is a novel, oral agent being tested  in a Phase II clinical program called OSCAR (Oral Suppression of Cellular Inflammation Attenuates Rheumatoid Arthritis) as an oral therapy for the treatment of rheumatoid arthritis. AGIX-4207 I.V. is an intravenous rheumatoid arthritis treatment that has completed a Phase I clinical study. AGI-1096 is a novel, oral agent that is being developed for the prevention of organ transplant rejection in collaboration with Fujisawa. For more information about AtheroGenics, please visit www.atherogenics.com .

 University of Pittsburgh approach has lung recipients taking far fewer drugs. -Findings being presented at the American Transplant Congress.  A lung transplant patient takes six pills a day, a regimen that is intended to safeguard the donor organ from immune system attack. But rejection plagues these patients more often and more vigorously than any other kind of organ recipient, so is it necessary that patients take that many pills? Not according to the experience of surgeons at the University of Pittsburgh Medical Center (UPMC), where some lung transplant recipients are getting away with taking just one anti-rejection pill daily, and others just the one pill four or five times a week, with no ill effects.Results of the novel clinical protocol were presented today by Kenneth  McCurry, M.D., assistant professor of surgery at the University of Pittsburgh School of Medicine, at the American Transplant Congress (ATC), the joint scientific meeting of the American Society of Transplant Surgeons and the American Society of Transplantation.With more than a year of follow-up in many patients, Dr. McCurry found that even those patients who have been able to reduce their medications to one pill a day benefit from the approach, which differs from the conventional twice-a-day triple-drug therapy, said Dr. McCurry. "Bombarding the immune system with several very potent drugs has done little to improve the outcomes for lung transplant recipients, who continue to have poor survival  about 75 percent at one year  compared to other organ recipients. Moreover, the drugs have not done well to prevent chronic rejection, which affects about half of lung transplant patients by five years and usually results in organ failure and death. These bleak outcomes have motivated us to introduce an approach that we hope will enhance long-term survival, reduce the rates of complications associated with these drugs and improve quality of life," said Dr. McCurry, who also is director of lung and heart-lung transplantation at UPMC.The approach is the only one of its kind involving lung transplant patients, in whom studies that seek to reduce anti-rejection drugs are rarely performed out of fear that the lungs, already the most vulnerable organ to rejection, would succumb to an irreversible immune system attack, placing patients at risk for death. Ironically, lung recipients have the greatest incidence of immunosuppression-related complications, such as infection and chronic kidney dysfunction, providing incentive to search for alternative immunosuppression approaches. UPMC's clinical protocol involves a one-time dose of a drug that depletes T cells  key immune system cells that are known to target the donor organ  that is given just before transplantation. Following transplantation, patients are treated with just one anti-rejection drug,  tacrolimus, that is administered at reduced levels. Since many lung recipients are treated with prednisone for their underlying disease, the steroid is continued after transplant but at a negligible dose, 5 mg compared to 20 mg.The rationale is to treat patients with as little immunosuppressive medication as possible following the transplant while preventing injury to the graft by the recipient's immune system. Since June of 2002, more than 80 patients have been treated under the protocol. At ATC, Dr. McCurry reported results in many of these patients, including 31 who have been followed for more than a year after transplant, several for nearly two years. The first 38 patients were given a pre-transplant drug called Thymoglobulin. One-year survival for these patients is 87 percent. The remaining patients received Campath, which appears to deplete T cells more broadly and for a longer period of time. Acute rejection episodes have been less in the Campath patients reported on at ATC compared to those who received Thymoglobulin. Twenty-five of the 38 Thymoglobulin patients had rejection episodes greater or equal to Grade 2, compared to two of the first10 Campath treated patients.There were no opportunistic infections or related complications in the patients treated with Campath; a small percentage of the Thymoglobulin patients developed either cytomegalovirus (8 percent), the bacterial infection Nocardia (8 percent) or post-transplant lymphoproliferative disorder (3 percent), rates that were comparable to conventionally treated patients. One-year follow-up results are not yet available to compare survival between the Thymoglobulin-treated and Campath-treated groups. However, the overall patient survival for Thymoglobulin-treated patients is 84 percent while in the Campath-treated patients it is 98 percent. "We are encouraged by these preliminary results. What remains to be seen is if our approach will have an impact on chronic rejection," said Dr. McCurry. "At this point, I think we can say that the standard multi-drug approach to immunosuppression may be excessive and leads to increased complications. Moreover, our promising early results suggest that altering the approach and reducing immunosuppression is not as risky as some would have guessed. The next step we should consider is a multi-center, randomized trial. Only with that kind of data might the transplant community embrace the notion that radical change is warranted," noted Dr. McCurry. "Personally, I think our approach will presage significant improvements in outcomes for lung transplantation," he added. To schedule interviews with Dr. McCurry call Lisa Rossi at 412-916-3315. Additional Contact Information: Lisa Rossi (cell 412-916-3315) Maureen McGaffin PHONE: 412-647-3555 FAX: 412-624-3184 E-MAIL: McgaffinME@upmc.edu