ImmuKnow(R), Cylex's Immune Function Test, Expands Role In Guiding Therapies Relating To Organ Transplants

Main Category: Transplants / Organ Donations
Also Included In: Immune System / Vaccines;  Conferences;  Clinical Trials / Drug Trials
Article Date: 10 May 2007 - 0:00 PDT

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Cylex Incorporated, a life sciences company and leader in immune function testing, today announced that results from twenty-one clinical studies utilizing Cylex's flagship product ImmuKnow(R) are being presented at the American Transplant Congress, May 4-9 in San Francisco. Concurrently, the Company is also participating in the European Federation of Immunogenetics (EFI) in Barcelona, Spain. Data using ImmuKnow in heart and lung transplant recipients was recently presented as well at the Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT), held in San Francisco April 24-28.

ImmuKnow is the first and only FDA-approved assay that directly measures the state of a patient's immune system functioning from a single drop of blood. The information yielded by the assay can then be used to help guide doctors in administering the correct amount of immunosuppressant drugs to transplant patients. While the Cylex test has been initially applied to guiding therapies relating to organ transplants, the assay can also be effectively used in a wide range of other therapeutic areas, including bone marrow transplants, autoimmune disorders, cancer, HCV and HIV.

Independent clinical studies using ImmuKnow(R), to be presented in oral and poster formats at the transplant conferences, were conducted at some of the most prestigious transplant institutions in the U.S. These institutions include Cedars-Sinai Medical Center in Los Angeles; the Cleveland Clinic; University of Pittsburgh Medical Center; University of Rhode Island; Integris Baptist Medical Center; University of Oklahoma; and Penn State University's Hershey Medical Center.

The studies cover the full range of transplanted organs, such as heart, kidney, liver, as well as pediatric heart and kidney. The clinical results further verify that ImmuKnow effectively helps in the management of immune system functioning in transplant patients because the inexpensive and easy-to- perform test can be used to regularly monitor a patient's immune system health. With that information in hand, doctors can then tailor individual drug regimens they administer to transplant patients to prevent organ rejection while avoiding infection.

"These latest studies verify the expanding role ImmuKnow is playing in the transplant arena both in the US as well as in Europe," said Judith Britz, Ph.D., Chairman and CEO of Cylex. "The data confirm that the use of ImmuKnow with transplant patients not only improves therapeutic outcomes, the ImmuKnow test also provides one of the only standardized methods for measuring the effectiveness of new therapies under study."

Research to be reported at the meetings, in both oral and poster sessions, includes the papers:

-- "Cylex(R) Immune Monitoring in Post Liver Transplant Hepatitis C Results in Improved Patient Outcomes Due to Optimal Immune Suppression Dosing," by a team led by the Integris Baptist Medical Center, Oklahoma City.

-- "Impact of Various Infectious Syndromes on the Immune Function Profile in Lung Transplant Recipients," reported by a team led by the University of Pittsburgh.

-- "Value of a Global Immune Cell Function Assay in Predicting Recurrent HCV in Liver Transplantation Patients," reported by a team from the Loma Linda University Medical Center.

-- "Diabetic Kidney Transplant Recipients Exhibit Reduced Biomarkers of T- and B-Cell Activity," reported by teams from the University of Rhode Island and Brown University.

-- "Use of Immune Monitoring to Manage Immunosuppression in Pediatric Renal Recipients," reported by researchers led by the University of Oklahoma Health Sciences Center.

-- "Immunosuppression Management Guided by Immune Cell Function Assay (ImmuKnow(R)) in Heart Transplant Recipients," reported by a research team from the Cleveland Clinic.

At the two U.S. conferences, Cylex sponsored Immune Monitoring Symposia highlighting clinical experience with ImmuKnow by leading clinicians at the University of Pittsburgh, UCLA, University of Chicago, University of Alabama and Cleveland Clinic.

According to Dr. Anthony Sebastian, Chief of Abdominal Transplant Surgery at Integris Baptist in Oklahoma City, "When our center adopted the use of ImmuKnow in 2003, we were hopeful that routine immune monitoring would result in better optimization of our use of immunosuppressants. We can now document that use of this assay has resulted in improved outcomes for our liver transplant recipients -- fewer biopsies, fewer days in the hospital, and lower drug dosing with reduced toxicity."

About Cylex Incorporated

Cylex is a life science company and a leader in the development and manufacture of unique products that use the immune system for predicting and managing human health. It is the first and only company to offer a patent- protected, FDA-cleared cellular assay of immune system function, ImmuKnow(R), which measures the vitality of a patient's immune system from a single drop of blood. This test enables physicians to better manage and personalize the treatment of life-threatening diseases, such as HIV, HCV, cancer and autoimmune disorders, as well as solid organ and bone marrow transplantation.

ImmuKnow(R) is currently incorporated into patient protocols at leading U.S. hospitals and clinics. It is the only standardized cellular assay, easily performed in the lab, with quick and accurate results. By optimizing therapy, ImmuKnow(R) helps the physician lower the cost of treatment and improve treatment outcome, reduce the side effects of drugs, and enhance the patient's prospects for long-term quality of life.

For further information, visit http://www.cylex.net.

Cylex Incorporated
http://www.cylex.net

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