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Generex stock up on positive FDA vaccine meeting

Generex has seen its share price rise by almost 10% after announcing that subsidiary Antigen Express concluded a positive pre-investigational new drug application meeting with the FDA regarding plans to begin clinical trials of an innovative bird flu vaccine.

Investigators for the upcoming Clarification of Optimal Anticoagulation through Genetics Trial (COAG Trial) have selected Osmetech’s Warfarin Sensitivity Tests and eSensor XT-8 molecular diagnostics instrument platform for ten of the twelve sites identified to run the trial. The University of Pennsylvania is the Coordinating Center for the trial.

The study has been designed as a 1,238 patient, randomized, double-blind trial which will examine the utility of using genetic information for warfarin dosing. Specifically, the COAG trial will test two approaches to determining the initial dose of warfarin in patients who are expected to need therapy for three months or longer. Half of the participants enrolled in COAG will be randomly selected to have their initial dose determined by clinical information alone. For the other half of the participants, the initial dose will be determined by using the clinical factors as well as information about the participant’s genetic makeup, specifically his or her variants of the CYP2C9 and VKORC1 genes. All participants will be monitored for up to six months.

Researchers will assess how long participants in each group maintain the desired level of blood thinning, as determined by a blood test, at two and four weeks after starting therapy, as well as at three and six months. Researchers will also review bleeding problems and other complications, quality of life and cost of therapy.

James White, chief executive officer, Osmetech plc, said:

The high level of performance of our eSensor XT-8 System and Warfarin Sensitivity Test in the market since commercial launch in the second half of 2008 continues to gain recognition and this contract award should further enhance market acceptance of our platform.

Osmetech has won an opportunity to participate in a major study which will demonstrate the significance of genetic and clinical data in the prescription of a patient’s initial warfarin dose. The strength of our eSensor XT-8 platform and pipeline of tests puts us in an excellent position to benefit from the growing trend towards personalized medicine.

Dr. Stephen Kimmel of the University of Pennsylvania and lead investigator of the COAG Coordinating Center said:

We considered a number of alternative products and technologies for this important study, taking into account a number of factors including product performance and users’ experiences. We are pleased to be using Osmetech’s eSensor XT-8 System and Warfarin Sensitivity Test as one of the trial’s main genotyping platforms which should provide accurate, reliable and timely results from an easy to use and low maintenance system.