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.

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. Given this new delivery protocol, we have delineated the catheter delivery drug candidate as CVBT-141H.

This new injection catheter delivery clinical trial design was reviewed and approved by the FDA. The trial will be a double-blind placebo-controlled study with approximately 120 patients receiving one of three doses of CVBT-141H or a placebo dose. The clinical research organization, Kendle, will oversee and manage our international Phase II trial, which will be conducted at 30 sites worldwide in the U.S., Canada and Western Europe.

Procedure

This Phase II study will assess the safety and effectiveness of three dose levels of 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 FGF-1 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.

Enrollment Criteria

To qualify for the Phase II trial, a subject may 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.

Enrollment for the Phase II clinical trial for severe CHD has started.

Trial Locations

We are in the process of finalizing the list of our clinical trial locations for the Phase II severe CHD trial at 30 sites in the United States, Canada and Western Europe. If you are interested in learning more about enrolling in this trial please complete our Clinical Trial Inquiry Form.

The following site(s) are now open for patient enrollment:

The Christ Hospital & Mercy Hospital Fairfield; both in the Cincinnati, Ohio area
If you live in the Greater Cincinnati, Ohio area and want more information about this specific trial location, please contact the study coordinator:
Mary Lou Sauer, RNS, BSN, CCRC

Princeton Baptist Hospital/Center for Therapeutic Angiogenesis; in Birmingham, Alabama
If you live in or near Birmingham, Alabama, and want more information about this specific trial location, please contact the study coordinator:
Susan DeRamus, RN, CCRC

Please check back often for the latest information about participating clinical trial sites. We expect to post additional sites in the coming weeks.

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