Cylex Announces Plan For Multi-Center Trial Of ImmuKnow(R) Assay In South Korea

Main Category: Transplants / Organ Donations
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 30 Aug 2008 - 1:00 PDT

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"Cylex, Inc., in association with our Korean distributor, Sun Woo Biotech, is delighted to be able to announce our support for a major, multi-center trial of the ImmuKnow assay for cell-mediated immunity at seven highly respected medical institutions in the Republic of Korea," stated Brad Stewart, president of Cylex. "It is a critical goal for the Company to be able to demonstrate the effectiveness of the ImmuKnow assay in transplant populations of different ethnicities by working with specialized institutions around the world."

In the Republic of Korea, a multi-center consortium of kidney transplant centers will use the ImmuKnow assay to assess cell-mediated immunity of 238 patients between the ages of 15 and 60 who undergo an initial kidney transplant and who are randomly assigned to receive either triple immunosuppressive therapy (tacrolimus + mycophenolate mofetil + prednisone) or steroid-free immunosuppression (tacrolimus + mycophenolate mofetil only).

The seven institutions that will participate in this clinical trial include:

-- Samsung Medical Center (in Seoul)

-- KangNam St. Mary's Hospital (in Seoul)

-- Kyungpook National University Hospital (in Daegu)

-- Ajou University Hospital (in Suwon)

-- Daejeon St. Mary's Hospital (in Daegeon)

-- Soon Chun Hyang University Hospital (in Seoul)

-- Bong Seng Memorial Hospital (in Busan)

The ImmuKnow assay will be used to monitor all patients over a period of 36 months from initiation of treatment to assess the value of the assay predicting risk for organ rejection, in predicting risk for infection, and managing patients' immunosuppressed status with a goal of optimizing survival and minimizing organ rejection. Patients will have blood drawn and tested monthly with the ImmuKnow assay for the first 6 months of the study, and at 3-month intervals thereafter.

Study data from other respected centers, such as the recent data published by Sanchez-Velasco et al. in Spain,* have demonstrated the potential of the ImmuKnow assay as a tool to monitor the immune status of patients following kidney transplantation. "The working hypothesis of the current trial is that the investigators will observe similar results in a Korean population," said Kyu Young Woo, President of Sun Woo Biotech. "If this is the case, we will have a valuable mechanism to identify Korean patients at risk of infection or rejection of their transplant within 3 years of transplantation."

Sanchez-Velasco P, Rodrigo E, Valero, R. et al. Intracellular ATP concentrations of CD4 cells in kidney transplant patients with and without infection. Clin Transplant. 2008;22:55-60.

About ImmuKnow(R)

ImmuKnow is the immune cell function assay cleared by the FDA to detect cell-mediated immunity (CMI) in adult patient populations undergoing immunosuppressive therapy for organ transplantation by measuring the concentration of adenosine triphosphate (ATP) released from CD4 cells following cell stimulation.

The ImmuKnow test is a qualitative assay and does not directly quantify the level of immunosuppression. Results of ImmuKnow assays should be used in conjunction with clinical presentation, medical history, and other clinical indicators when assessing the immune status of any individual patient. The uses of the ImmuKnow assay as described in these studies have not been approved or cleared by the FDA. The Company may use data from these or similar studies to support future FDA marketing applications for similar indications.

About Cylex, Inc.

Cylex(TM) is a privately held global life sciences company that is the leader in the development and manufacture of in vitro diagnostic products intended to illuminate immunity. The Company's patented technology provides an innovative platform allowing clinical researchers to simply and reproducibly measure immune cell function for the development of new diagnostics, biomarkers, and companion assays. The Company is based in Columbia, MD, USA.

About Sun Woo Biotech

Sun Woo Biotech Corporation is a privately owned company specializing in marketing, sales, and distribution of healthcare-related products and services for the Korean market. In particular, the Company focuses on the marketing and distribution of laboratory-based diagnostic products and reagents, laboratory equipment, medical and surgical instruments, and disposable products for hospitals and clinical practices. The Company's offices are in Seoul, Republic of Korea.

Cylex, Inc.
http://www.cylex.net