ImmuKnow(R), Cylex's Immune Function Test For Guiding Post-Transplant Therapies, Receives Clinical Support In 17 Independent Studies

Main Category: Transplants / Organ Donations
Also Included In: Clinical Trials / Drug Trials
Article Date: 25 Jul 2006 - 0:00 PDT

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Cylex Incorporated, a life sciences company and leader in immune function testing, today announced that results from seventeen (17) clinical studies recently conducted by leading independent research institutions will be presented at the Annual Meeting of the World Transplant Congress (WTC), supporting the clinical utility of ImmuKnow(R), Cylex's flagship product for the assessment of global immune status in transplant recipients.

The WTC meeting will be held in Boston, at the Hynes Convention Center, July 22-26, 2006, and will include the Third Annual ImmuKnow(R) Symposium, sponsored by Cylex, on Tuesday, July 25, 12:00 PM - 2:00 PM at the Sheraton Hotel.

ImmuKnow(R) is the first and only FDA-cleared cellular assay that measures the vitality of a patient's immune system 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.

Independent clinical studies using ImmuKnow(R) to be presented at the WTC were conducted at some of the most prestigious transplant institutions in the U.S. and abroad. These institutions include Cedars-Sinai Medical Center in Los Angeles; David Geffen School of Medicine, University of California Los Angeles; University of Pittsburgh Medical Center; University of Texas Medical School in Houston; Rhode Island Hospital, Brown Medical School in Providence, RI; Duke University Medical Center in Durham, NC; The Miami VA Medical Center; and leading transplant centers in Spain and Israel.

In these studies, the clinical results related to the management of immune system functioning of transplant patients include the full range of transplanted organs, such as kidney, liver, heart, lung and pancreas. Because ImmuKnow(R) can directly gauge the level of functioning of a patient's immune system, 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 tailor individual transplant patient immunosuppressant drugs regimens administered to prevent organ rejection while avoiding infection.

"These studies provide important evidence to support the critical role ImmuKnow(R) plays in guiding the treatment of transplant patients," said Judith Britz, Ph.D., Chairman and CEO of Cylex. "The cumulative data confirm that the use of ImmuKnow(R) with transplant patients improves therapeutic outcomes by helping physicians to better balance the level of immunosuppressive drugs while minimizing and managing acute rejections and infections by incorporating a measure of immune activation in their routine management of the recipient."

Research to be reported at the meeting in both oral and poster sessions includes:

- Data from the Thomas E. Starzl Transplantation Institute at the University of Pittsburgh asserts in the abstract, "Our results show reasonable correlation between patient clinical and immunological status as quantitated by the Cylex assay. In particular, the assay was especially useful in the detection of highly immunosuppressed pancreas transplant patients vulnerable to infection."

- The Division of Organ Transplantation at Rhode Island Hospital applied immune function testing using ImmuKnow(R) to measure virus-induced suppression of two patients' immune systems that were further compromised when the patients acquired a donor-transmitted virus through their transplanted kidneys. These case studies originated from a case in May 2005 in which two kidney transplant recipients developed the donor transmitted Lymphocytic Choriomeningitis Virus (LCMV) that is typically found in rodents. ImmuKnow(R) was used to successfully track the state of the patients' immune system as doctors worked to clear the LCMV virus while gradually increasing immunosuppression drugs to avoid organ rejection. The study concluded that ImmuKnow(R) was a useful guide in restarting immunosuppression after LCMV was cleared.

- Transplantation clinicians at the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health will report that ImmuKnow(R) serves as a useful guide to monitoring and controlling immunosuppression following kidney transplantation. In addition, they will discuss how the assay serves as an indicator of the health of the immune system in the post-transplantation period.

- Clinicians at the University of Texas School of Medicine in Houston will report on patient outcomes, as determined, in part, from monitoring patient immune responses with ImmuKnow(R) after early steroid withdrawal in low-immune responder kidney-pancreas transplantation patients.

- Valdecilla Hospital in Santander, Spain will present a poster entitled, "Assessment about Risk of Infection in Kidney Transplant by Measuring the Concentration of ATP from CD4 T Cells Following Stimulation by Cylex." The abstract states, "The performance of the Cylex assay in the monitoring of kidney transplants may help us to differentiate which patients have the greatest risk of infection and individualize their treatment."

- Physicians at the David Geffen School of Medicine at the University of California Los Angeles used ImmuKnow(R) to monitor pediatric heart transplant patients. In their abstract, they assert, "The immune response of CD4 T cells as measured by the Cylex assay was elevated in patients with rejection episodes compared to clinically stable patients. Data presented here correlate immune response levels to clinical outcomes of stability and rejection and may be a useful tool for individualizing immunotherapy."

The Cylex-sponsored Third Annual ImmuKnow(R) Symposium will feature presentations by physicians that include Anthony Sebastian, MD, Integris Baptist; Stanley Jordan, MD, PhD, of Cedars Sinai and UCLA; Adriana Zeevi, PhD, University of Pittsburgh Medical Center; Debbie Rinde-Hoffman, MD, of Lifelink Foundation and Tampa General Hospital; Ken McCurry, MD, UPMC; and Ngoc Thai, MD, of UPMC.

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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