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Subject Final Cohort of ViroMed’s US Phase I Clinical Trial Set to Begin
Writer ViroMed
Date 2008/08/29
SEOUL, KOREA, Aug. 29 – ViroMed Co., Ltd. (KOSDAQ: 084990) today announced that the 3rd cohort of the Phase I clinical trial of VM202 for peripheral artery disease (PAD) ongoing at the Minneapolis Heart Institute in the US has passed its safety monitoring, and approval to begin testing on the 4th and final cohort has been received.

The current clinical trial consists of 12 patients, organized into 4 cohorts with differing dosages. After all the subjects in each cohort have completed a certain period of follow-up, an interim safety evaluation will be performed with the submission of data to the Data Safety Monitoring Board (DSMB). If the DSMB recommends continuing the study, the next cohort will be tested. To date, the DSMB has approved safety evaluations for three cohorts.

One advantage is that, as a gene-based therapeutic, VM202 is administered to patients with the relevant disease who can also give some feedback on the therapeutic effects of the drug, compared to a regular Phase I clinical trial administered to healthy people, which can only be used to evaluate the safety.

"The highest dosage will be administered to the 4th cohort," says Jong-Mook Kim, Head of Research at ViroMed. "Patients are being enrolled faster as more results from previous cohorts are released. Therefore, we expect this last cohort to be completed at a much faster pace than before."

In addition, the Minneapolis Heart Institute will present the interim results of this clinical trial at the world’s largest cardiovascular conference attended by the foremost authorities on cardiovascular diseases later this year.

Glossary
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Cohort
In a clinical trial, a cohort is a well-defined group of subjects or patients who have a common experience or exposure (i.e., the same dosage of a medicine) and are then followed up for the after-effects and side-effects, if any. It is common practice in a clinical trial to increase the dosage for each successive cohort to find the most effective dosage.

Data Safety Monitoring Board (DSMB)
An independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Also referred to as the Data Monitoring Committee (DMC).

List of VM202’s CVD therapeutics: countries and phases
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Korea
Target disease: Coronary Artery Disease (CAD)
Phase I ongoing / Partner Institutes: Reyon Pharmaceutical Co., Ltd., Seoul National University Hospital Department of Thoracic and Cardiovascular Surgery

USA
Target disease: Peripheral Artery Disease (PAD)
Phase I ongoing / Partner Institute: Minneapolis Heart Institute

China
Target disease: Peripheral Artery Disease (PAD) / clinical approval received on June, 2008
Phase I to begin in 2nd half of 2008 / Partner Institute: Beijing Northland Biotech