GenVec Announces NIH Funding For Balance And Hearing Loss Program

Main Category: Hearing / Deafness
Article Date: 20 Dec 2007 - 3:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

GenVec, Inc. (Nasdaq:GNVC) announced that it has received a sub-award under a grant from the National Institute on Deafness and Other Communication Disorders (NIDCD), of the National Institutes of Health (NIH), to develop a gene-based drug therapy to treat severe balance disorders. GenVec will receive up to $1,125,000 over five years to support pre-clinical research in collaboration with Dr. Hinrich Staecker, University of Kansas Medical Center, leading to the development of a drug candidate for clinical testing.

Work under the grant will include the advancement of a lead development candidate to deliver and express the human atonal gene, generation of materials for pre-clinical testing, and generation of additional pre-clinical data to support an Investigational New Drug (IND) filing for a Phase I clinical trial. The grant will leverage Dr. Staecker's expertise in inner ear clinical research and GenVec's proprietary technologies and know-how in bringing adenovector gene delivery strategies into clinical trials. Work under the grant will explore the use of advanced generation adenovectors that further enhance delivery, selectivity, and potency of the vector system.

In February, GenVec announced the publication of pre-clinical research demonstrating that delivery of the atonal gene utilizing GenVec's proprietary adenovector technologies can regenerate lost sensory hair cells and revive inner ear function, a major requirement in the development of restorative therapeutics. The proof-of-concept study, authored by investigators from University of Kansas School of Medicine, University of Heidelberg, and GenVec, appeared in the February 2007 issue of Otology & Neurotology. The goal of this grant is to translate these research results into an IND application for the treatment of aminoglycoside-induced bilateral vestibular hypofunction (BVH).

"This program will support the pre-clinical development of an atonal product candidate and allow us to explore potentially important enhancements to our adenovectors," said Douglas J. Swirsky, GenVec's Chief Financial Officer. "This represents another example of GenVec's ability to advance its technology efficiently through the selective use of grants and other collaborations."

"Hearing and balance disorders represent significant medical needs for which new approaches are needed," added Dr. Doug Brough, GenVec's Senior Director of Vector Sciences. "Delivery of atonal genes using GenVec's proprietary adenovectors has already demonstrated the potential to restore balance function in pre-clinical models. We believe this translational research has the potential to lead to the development of a first-in-class therapeutic that could cure certain balance disorders, not just treat them."

About Bilateral Vestibulopathy

Bilateral vestibulopathy (BVH) occurs when the balance system associated with the semicircular canals of the inner ear are damaged or destroyed. Nearly 50% of all cases can be attributed to the use of ototoxic drugs, such as gentamicin. Six to ten percent of patients prescribed aminoglycosides such as gentamicin, a commonly used antimicrobial drug, develop symptoms of BVH. Symptoms typically include severe dizziness, imbalance, and visual disturbances when trying to track moving objects and often are accompanied by hearing loss.

About GenVec

GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec's lead product, TNFerade™ is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. Additional clinical trials are in progress in rectal cancer, head and neck cancer and melanoma. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and influenza. Additional information about GenVec is available at http://www.genvec.com and in the company'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 revenues and operating expenses, 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 results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are 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.