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Three Year Phase I Myoblast Cell Transplantation Study Data Presented at American College of Cardiology Scientific Sessions

Posted on: Tuesday, 8 March 2005, 15:00 CST

GAITHERSBURG, Md., March 8 /PRNewswire/ -- GenVec, Inc. , announced that three year follow-up data from a Phase I study of its myoblast cell transplantation therapy for congestive heart failure were presented today at the 2005 American College of Cardiology 54th Annual Scientific Session in Orlando, Florida. The purpose of this multicenter study was to demonstrate the safety and feasibility of using autologous myoblast transplantation to repair damaged heart tissue in patients who have suffered a heart attack.

In the study, myoblasts were harvested from the leg muscles of 30 patients and then cultured using GenVec's proprietary technique. Twenty-four patients received escalating doses of each patient's own purified myoblasts, which were injected into the area of the heart scarred by previous myocardial infarction during a previously scheduled coronary artery bypass surgery. Additionally, 6 patients scheduled to have Left Ventricular Assist Device (LVAD) implantation as a bridge to heart transplant received cells at the time of LVAD surgery. The findings, presented by Nabil Dib, M.D., M.Sc., FACC, Director of Cardiovascular Research at the Arizona Heart Institute, included evidence of safety with no increased risk of arrhythmia. Encouraging evidence of myocardial remodeling, as shown by MRI, and of tissue viability, as shown by PET scan and MRI, was also seen. The results indicate that myoblast transplantation is feasible and safe in patients who have suffered myocardial infarction and are scheduled to undergo coronary artery bypass surgery or receive a LVAD, and that this approach to repairing damaged heart muscle warrants further study.

As the data from these studies were identified as newsworthy for this year's Scientific Sessions, the results were highlighted by Dr. Dib today at the ACC press briefing entitled "Late-Breaking Clinical Trials: Mechanisms and New Therapeutics Approaches" and subsequently detailed in his presentation, "Three Year Follow-up of Autologous Myoblast Transplantation for Ischemic Cardiomyopathy in Patients Undergoing Coronary Artery Bypass Grafting."

GenVec is a biopharmaceutical company developing treatments for cancer, heart disease, vision loss, and vaccines for infectious diseases. Myoblast cell transplantation has not been approved for use by the U.S. Food and Drug Administration or any other regulatory body. Additional information on GenVec is available at http://www.genvec.com/ and in GenVec's various filings with the Securities and Exchange Commission.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future studies and programs, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the statements herein include risks relating to the early stage of myoblast cell transplantation development; GenVec's ability to secure and maintain relationships with collaborators; uncertainties with, and unexpected results and related analyses relating to clinical trials of GenVec's product candidates; the growth of revenues attributable to GenVec's vaccine program; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or its collaborators; dependence on the efforts of third parties; dependence on intellectual property; risks that GenVec may lack the financial resources and access to capital to fund its operations; and risks relating to the commercialization, if any, of GenVec's product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks). Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations is contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov/. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

GenVec, Inc.

CONTACT: Rena Cohen, Corporate Communications of GenVec, Inc.,+1-240-632-5501, or rcohen@genvec.com

Web site: http://www.genvec.com/

Source: PRNewswire

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