Navigation Links
Cylex Announces Plan for Multi-Center Trial of ImmuKnow(R) Assay in South Korea
Date:8/28/2008

Seven Korean medical centers to collaborate on studies of immunosuppression

in kidney transplant patients and role of cell-mediated immunity

COLUMBIA, Md., Aug. 28 /PRNewswire/ -- "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.


'/>"/>
SOURCE Cylex, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Independent Studies Report on Possible Roles for Cylexs Immune Cell Function Assay in Monitoring of Heart and Lung Transplant Recipients
2. Intercell Announces Initiation of Further Phase II Clinical Trial of V710 an Investigational Vaccine to Prevent S. aureus Infection
3. The University of Nottingham in the British Midlands Announces Breakthrough in Parkinsons Disease Research
4. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2008
5. CRi Announces New Maestro(TM) EX In Vivo Imaging System with Improved Performance and an Affordable Price
6. XTENT Announces CUSTOM II Data Selected for Publication in EuroIntervention
7. Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program
8. Omeros Announces Publication of Clinical Results for OMS103HP in Arthroscopy: The Journal of Arthroscopic and Related Surgery
9. Genmab Announces Upcoming Ofatumumab Studies
10. Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000
11. Catalyst Pharmaceutical Partners Announces Publication of Animal Data Demonstrating Vigabatrin Effective for Weight Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... CITY, Mo. , May 3, 2016 /PRNewswire/ ... Kansas Medical Center,s Institute for Advancing Medical Innovation ... and commercialize new drugs, diagnostics and medical devices. ... provides BioNovus Innovations with rights to license, develop ... "This partnership represents ...
(Date:5/3/2016)... , May 3, 2016  As a teenager, an ... rheumatic fever, which damaged his heart. He continued enjoying ... by June 2013, Shepherd,s heart was giving out and ... On June 20, 2013, the Mesa, Arizona ... Heart (TAH-t). Like a heart transplant, the SynCardia TAH-t ...
(Date:5/3/2016)...  While you may be familiar with watching a film or TV show in high definition, ... 8MP in the Medical Industry.  Ampronix  is a renowned authorized reseller of the medical industry,s ... - http://photos.prnewswire.com/prnh/20160502/362730 ... ... ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... 05, 2016 , ... Chronic stress can have a silent, yet dangerous, impact ... immune system and increase inflammation, both of which raise the risk of heart attack ... disease program at Harvard-affiliated Massachusetts General Hospital. Chronic stress also can lead to other ...
(Date:5/5/2016)... , ... May 05, 2016 , ... ... honored finalists and winners Tuesday evening, May 3, at the 2016 ISE® Central ... , Scott Pettigrew, Vice President and Chief Security Officer of HMS, was selected ...
(Date:5/5/2016)... , ... May 05, 2016 , ... If you don’t ... marks on your skin, you may want to consider a treatment that some have ... Advanced Dermatology P.C. , Microneedling, also known as skin needling, is a ...
(Date:5/5/2016)... Austin, TX (PRWEB) , ... May 05, 2016 , ... ... existence to offer the breakthrough technology of the new PiQo4™ laser, the first 4-wavelenth ... treating more tattoo inks than any other picosecond laser on the market. Jeremy ...
(Date:5/5/2016)... ... 05, 2016 , ... Liposuction specialist Marcia V. Byrd, MD spoke last month ... the Marriot St. Louis Airport Hotel. This year’s conference was titled “Living with Lipedema ... her unique specialization in treating Lipedema. Dr. Byrd is considered one of the leading ...
Breaking Medicine News(10 mins):