COLUMBIA, Md., Aug. 28 In association with its Italiandistributors, ADA SRL, Cylex, Inc. today announced that the value of itspatented ImmuKnow assay will be investigated in one part of a major,three-part, Italian trial of aspects of immunosuppression in patientsundergoing liver transplantation subsequent to hepatitis C virus (HCV)-relatedcirrhosis of the liver.
"Cylex is honored to be working with Prof. Antonio Daniele Pinna, MD, andhis colleagues at the University of Bologna and other centers in exploring thepotential value of ImmuKnow in monitoring the cell-mediated immunity ofpatients following liver transplantation," stated Brad Stewart, president ofthe Company. "Professor Pinna is a renowned authority in this field, and welook forward to supporting his team as necessary through the course of thistrial."
Under the leadership of Prof. Pinna, the ImmuKnow assay will be used inone part of this three-part, multi-center trial in patients undergoing initialtransplantation for hepatitis C virus (HCV)-related cirrhosis of the liver(with or without hepatocellular carcinoma). The three-part trial is designedto evaluate several primary research objectives:
-- To compare the incidence of acute rejection and HCV recurrence betweenthe study group (receiving an investigational immunosuppressive regimen) and acontrol group (receiving a standard regimen)
-- To reduce infection and acute rejection in a population of livertransplant recipients assessed using the Cylex ImmuKnow assay compared to acontrol group, allowing an earlier intervention able to reducehospitalizations secondary to infection or transplant rejection
-- To develop novel diagnostic tools to distinguish acute HCV recurrencefrom acute rejection and to identify specific parameters able to predictseverity of recurrence and rapidity of evolution of HCV re-infection
The value of the ImmuKnow assay as a method to monitor cell-mediatedimmunity and evaluate the need to modify the level of immunosuppression ofindividual patients will be addressed in the second part of this three-parttrial, as specified above. A sample size of 103 patients will be required toassess the value of ImmuKnow in this study. Patients enrolled in thefirst-mentioned section of the study will be eligible for enrollment in theImmuKnow evaluation study.
Patients in this study will be classified according to standard ImmuKnowcriteria for cell-mediated immunity, as defined in the product's packageinsert. All patients will have blood drawn and tested on a regular scheduleimmediately prior to and following surgery for a period of 1 year. Tests willbe conducted according to the following schedule:
A total of 14 ImmuKnow tests per patient will be carried out (for eachpatient without complications).
"Evolving data strongly suggest the value of Cylex's cell-mediated immunefunction assay in monitoring patients undergoing liver transplantation,"stated Prof. Pinna. "Our intent is to investigate whether these data can bereplicated in an Italian clinical trial population, thereby confirming thepotential of the ImmuKnow assay as a standard monitoring technology for long-term follow-up of liver transplant patients."
ImmuKnow is the immune cell function assay cleared by the FDA to detectcell-mediated immunity (CMI) in adult patient populations undergoingimmunosuppressive therapy for organ transplantation by measuring theconcentration of adenosine triphosphate (ATP) released from CD4 cellsfollowing cell stimulation.
The ImmuKnow test is a qualitative assay and does not directly quantifythe level of immunosuppression. Results of ImmuKnow assays should be used inconjunction with clinical presentation, medical history, and other clinicalindicators when assessing the immune status of any individual patient. Theuses of the ImmuKnow assay as described i