Multiple Independent Studies Report on Use of Cylex’s Immune Cell Function Assay in Postoperative Monitoring of Kidney, Liver, and Heart Transplant Recipients

COLUMBIA, Md., May 30 /PRNewswire/ — On Saturday, May 31 through Tuesday, June 3, at the annual American Transplant Congress (ATC) in Toronto, Canada, a total of 13 presentations will either report specifically on studies of the use of the ImmuKnow assay or will include information on the use of this assay in monitoring kidney, liver, and heart transplant patients over time.

Since it was initially cleared as an in vitro diagnostic technique to detect cell-mediated immunity (CMI) in adult patient populations undergoing immunosuppressive therapy for organ transplantation, understanding of the possible applications of the Cylex(TM) ImmuKnow assay (in clinical practice and in the clinical research setting) has continued to expand. Selected institutions are expected to issue their own detailed media information about individual studies (highlighted in bold type below). However, the full list of studies that is known to either focus on or include explicit reference to use of the ImmuKnow assay for CMI is as follows:

   Saturday, May 31, 2008   — “Is infection in heart transplant patients related to low immune cell       function or low white blood cell count or both?” (B. Pavlovic       Surjancev, P. Lingam, N. Patel, et al.) — poster presentation, 5:30       p.m. – 7:00 p.m. (Poster Session: Heart Transplantation I)           This study, from Loyola University Medical Center in Maywood, IL,       assesses relative values of cell-mediated immunity, white blood cell       count, and lymphocyte count in monitoring 26 heart transplant patients       of whom 15 had various infections.    — “Sirolimus (SRL) blunts mitogen response at trough (C0) levels more      than cyclosporine (CSA) or tacrolimus (TAC) — a safeguard for our many      long-term noncompliant kidney transplant patients (KTPs)” (X. Ye, N.      Khosla, R. Batarse, et al.)    — – poster presentation, 5:30 p.m. — 7:00 p.m. (Poster Session:      Psychosocial and Compliance Issues)           Mitogen response to three different immunosuppressive agents was      assessed in 160 kidney transplant patients at an average of more than 6      years post-surgery using the Cylex ImmuKnow assay in this study from      the University of California San Diego School of Medicine, San Diego,      CA.    — “Anti-CD20 monoclonal antibody (Rituximab) clears persistent post      transplant (TX) EBV viremia, but the effect may not be sustained” (L.      Jinadu, M. Toyoda, E. Kamil, et al.) — poster presentation, 5:30 p.m.      — 7:00 p.m. (Poster Session: Kidney: Pediatrics)           This study, from Cedars Sinai Medical Center in Los Angeles, CA,      includes reference to the use of ImmuKnow in serial monitoring of 5      pediatric renal transplant patients being treated for persistent      Epstein-Barr viremia.     Sunday, June 1, 2008   — “Effect of induction agent on cellular and humoral responses to renal      transplants in sensitized patients” (M. S. Leffell, D. Kopchliiska, D.      P. Lucas, et al.) — oral presentation, 3:35 p.m. (Concurrent Session:      Immunosuppression: Protocols for Sensitized and ABO Incompatible Renal      Transplantation: A Period of Consolidation)           CMI was one of three parameters assayed in monitoring the      responses of renal transplant patients to two different induction      agents in this study from Johns Hopkins University School of Medicine,      Baltimore, MD.    — “411 living donor kidney transplants using alemtuzumab pre-conditioning      and tacrolismus monotherapy: 5-year experience” (H. P. Tan, J.      Donaldson, A. Basu, et al.) — oral presentation, 4:20 p.m. (Concurrent      Session: Kidney Immunosuppression: Induction Therapy I)           This study from the University of Pittsburgh Medical Center      reports the 5-year results of the largest series (to date) of living      kidney donor transplants with alemtuzumab preconditioning, including      the role of the Cylex ImmuKnow assay in patient monitoring to assist in      the weaning of recipients to tacrolimus monotherapy.    — “Monitoring of immune function for treatment of post-transplant de novo      malignancy” (T. Uemura, T. R. Riley III, A. Khan, et al.) — poster      presentation, 5:00 p.m. — 6:00 p.m. (Poster Session:      PTLD/Malignancies: All Topics)           The Cylex ImmuKnow assay was used to compare outcomes of 52 kidney      and liver transplant patients with de novo malignancies post transplant      in this study from the Penn State Milton S. Hershey Medical Center,      Hershey, PA.    — “New insights into the use of immune cell function monitoring in kidney       transplant management” (F. Benitez, A. Gautam, and N. Najafian) —       poster presentation, 5:00 p.m. — 6:00 p.m. (Poster Session: Non       Invasive Immune Monitoring II)           This pilot study from the Children’s Hospital, Brigham and Women’s       Hospital, and Boston Medical Center, Boston, MA suggests three new       findings related to the use of CMI in post-transplant monitoring of       patients with kidney transplants.     Monday, June 2, 2008   — “Rejection characteristics of 200 living donor kidney transplants using       alemtuzumab induction and tacrolismus monotherapy” (H. P. Tan, J.       Donaldson, A Basu, et al.) — oral presentation, 2:15 p.m. (Concurrent       Session: Kidney — Acute Rejection: Immunosuppressive Agents and       Registry Data)           This study from the University of Pittsburgh Medical Center       reports the longest (3-year) follow-up of the largest series (to date)       of living kidney donor transplants with alemtuzumab preconditioning       and tacrolimus monotherapy, including the role of the Cylex ImmuKnow       assay in patient monitoring.    — “Relationship between immune function and humoral sensitization in      renal transplant recipients” (A. Zeevi, C. Bentlejewski, A. Girnita et      al.) — poster presentation, 5:00 p.m. — 6:00 p.m. (Poster Session:      Kidney Immunosuppression: Induction Therapy)           This study of 290 samples from 39 renal transplant recipients from      the University of Pittsburgh Medical Center and Cylex, Inc. suggests      that cell-mediated immune function and anti-HLA antibody screening      tests are independent measures of different arms of the immune      response.    — “ATP levels (ATP) analyzed by Cylex ImmuKnow assay (ICF) are useful to      guide management of CMV and BKV infection, but has limited utility for      EBV” (D. Thomas, A. Pao, D. Puliyanda, et al.) — poster presentation,      5:00 p.m. — 6:00 p.m. (Poster Session: Kidney: Complications IV)           The role of CMI in guiding the management of CMV and BKV      infections in 194 kidney transplant patients over a period of 3 years      is clarified in this study from the Cedars Sinai Medical Center, Los      Angeles, CA.    — “Immune monitoring with Cylex ImmuKnow in the management of post kidney      transplant recipients” (M. R. Carreno, T. Cordovilla, Y Jin, et al.) —      poster presentation, 5:00 p.m. — 6:00 p.m. (Poster Session: Kidney:      Complications IV)           The role of CMI in guiding the post-transplantation management of      339 kidney transplant patients is examined in this study of over 2,000      test specimens from the University of Miami Lawrence Miller School of      Medicine, Miami, FL.    — “The ATP release assay in normal, dialysis and transplant patients, and      its practical application” (E. A. Santiago-Delpin, S. de Echegaray, D.      M. Perez, et al.) — poster presentation, 5:00 p.m. — 6:00 p.m.     (Poster Session: Kidney: Complications IV)           This case-control approach to measuring CMI involved monitoring      Hispanic kidney transplant patients together with CMI values in normal      Hispanics and Hispanic patients on dialysis in this study from the      University of Puerto Rico, San Juan, PR.     Tuesday, June 3, 2008   — “Impact of Cylex immune cell function assay in predicting acute      cellular rejection and recurrence of HCV in liver transplantation” (K.      Hashimoto, K. Hirose, T. Diago Uso, et al.) — poster presentation,      5:00 p.m. — 6:00 p.m. (Poster Session: Liver: Hepatitis)           The role of CMI in monitoring 63 patients receiving orthotopic      liver transplants, with a specific focus on the ability to distinguish      acute cellular rejection from HCV recurrence, is examined in this study      from The Cleveland Clinic, Cleveland, OH.    

The various studies report on the clinical use of the ImmuKnow immune function assay in adult and in pediatric patients. The use of the ImmuKnow assay for identification of patients at risk for organ rejection and/or infection, as described in some of these studies, has not been cleared by the U.S. Food & Drug Administration (FDA). The company may use data from these or similar studies to support future FDA marketing applications.

About ImmuKnow(R)

ImmuKnow is an immune cell function assay that can detect cell-mediated immunity 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 ImmuKnow assay has not been cleared by FDA for assessment of immune cell function in pediatric patients.

About Cylex, Incorporated

Cylex(TM) is a privately held global life sciences company and a leader in the development and manufacture of research and in vitro diagnostic products intended to assist in the assessment of immune function. Cylex is the first and only company to offer a patent-protected in vitro diagnostic assay (ImmuKnow) used in the detection of cell-mediated immune function in immune-suppressed organ transplant patient populations. The ImmuKnow assay is increasingly being adopted for use by organ transplant centers throughout the USA and in other countries around the world.

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.

    CONTACT:    Lynn Shepherd                  Ketura Lispi                Vox Medica                     Vox Medica                (267) 250-7376                 (215) 925-9901                lshepherd@voxmedica.com        klispi@voxmedica.com  

Cylex, Incorporated

CONTACT: Lynn Shepherd, +1-267-250-7376, lshepherd@voxmedica.com, orKetura Lispi, +1-215-925-9901, klispi@voxmedica.com, both of Vox Medica forCylex, Incorporated