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ImmuKnow®, Cylex's Immune Function Test for Guiding Post-Transplant Therapies, Receives Clinical Support in 17 Independent Studies

Eight Clinical Abstracts Accepted for Oral Presentation; Nine Abstracts

Accepted for Poster Sessions at World Transplant Congress, July 22-26, 2006

COLUMBIA, Md., July 24 /PRNewswire/ -- 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®, 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® Symposium,

sponsored by Cylex, on Tuesday, July 25, 12:00 PM - 2:00 PM at the Sheraton


ImmuKnow® 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® 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


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® 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® 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® 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


- 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® 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® 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® 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® 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® 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


- Physicians at the David Geffen School of Medicine at the University of

California Los Angeles used ImmuKnow® 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® 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. For more information on the Cylex Symposium, please

contact: info@cylex.net

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®, 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


ImmuKnow® 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® 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.

Media Contacts:

David Kalson, RF|Binder Partners



Kirsten Plonner, RF|Binder Partners



SOURCE Cylex Incorporated


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