Phase I: Overview

We have completed the enrollment and treatment of all subjects specified in our Phase I clinical trial protocol for the surgical delivery of our drug candidate CVBT-141A. A total of 21 patients were treated at six participating U.S. medical centers that were managed by our contract clinical research organization. We filed an interim report with the FDA, as required, listing any adverse events or other safety issues observed in this trial up to and including the 12 week follow-up visit of all patients in this trial.

Phase II: The ACORD Trial

The ACORD (Angiogenesis for the treatment of CORonary heart Disease) trial will include four randomized, double-blind, placebo-controlled doses in approximately 120 patients with severe coronary heart disease. Thus far, nine patients have been enrolled of which seven patients have been randomized and dosed. Thirty sites are expected to participate. The clinical research organization, Kendle, is overseeing and managing our Phase II trial.

ACORD: Overview

Based on a recommendation from the FDA for our Phase II protocol, we have changed the manner in which we administer our drug candidate from surgical delivery to an injection catheter delivery system, which permits the examination of a placebo control group that was not possible in the Phase I trial. The MyoStar® injection catheter manufactured by Biologics Delivery Systems, a subsidiary of Cordis Corporation, will be used in this study. This new injection catheter delivery clinical trial design was reviewed and allowed by the FDA. Given this new delivery protocol, we have delineated the catheter delivery drug candidate as CVBT-141H.

ACORD: Procedure

This ACORD study will assess the safety and effectiveness of three dose levels of our drug (CVBT-141H) to subjects on optimal medical therapy for chronic angina. Left ventricular regional wall motion and electrical activity will be determined via the NOGA® XP Cardiac Mapping System then the drug will be delivered by multiple intramyocardial injections into ischemic myocardium using the MyoStar Injection Catheter. Both the mapping and injection catheters were developed by Cordis Corporation.

In the Phase I study, FGF-1 was administered by intramyocardial injections via a mini-thoracotomy. The Phase II study will utilize an injection catheter to deliver the drug to essentially the same region in the heart wall, but will not require surgical intervention. The Phase II trial use of a catheter to deliver CVBT’s drug candidate permits the comparison of its benefits to a placebo control group, which was not possible when the drug was administered during a surgical mini-thoracotomy in the Phase I study.

Efficacy will be measured by evidence of improved myocardial perfusion and function via anginal questionnaires, SPECT scans, exercise tolerance, NOGA electromagnetic mapping and angiography. In addition, each dose group will be compared for safety and tolerability through monitoring for serious adverse events (SAEs), laboratory tests, physical exams, electrocardiograms (ECGs) and ophthalmological exams.

ACORD: Patient Enrollment Criteria

To qualify for the ACORD trial, a subject must be between 25 and 75 years of age with at least a 3 month history of chronic stable angina triggered by physical exertion and must have a Canadian Cardiovascular Society (CCS) anginal classification III or IV (the four classifications specify I as the lowest level of severity and IV as the highest) while receiving optimal medical therapy.

Subjects must also have documentation of narrowing of a major coronary artery or diffuse type of CHD. Their treating cardiologist will have determined that they are generally not suitable for interventional therapy or CABG surgery.

ACORD: Trial Locations

We are in the process of finalizing the list of our clinical trial locations for the ACORD trial. If you are interested in learning more about enrolling in this trial please complete our Clinical Trial Inquiry Form.

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