Ticker Symbol: GNVC
Drug's Statuses: 2 in Clinical Trials, 1 in Pre-Clinical testing, 1 currently halted
GenVec is a biopharmaceutical company that develops gene-based drugs and vaccines that deliver proteins directly to the site of the disease. The company is currently testing drugs in clinical trials to treat various forms of cancer, as well as age-related macular degeneration, coronary artery disease, and hearing loss. The company also develops and tests products in collaboration with government institutions. These collaborations are the company’s only current source of revenue. GenVec is currently working on projects with the United States Department of Homeland Security, the National Institute of Allergy and Infectious Diseases and the National Institute of Health to treat such diseases as HIV, malaria, influenza, and foot and mouth disease.
The company is of a high-risk profile, and should be considered speculative in nature by investors. Some of the risks involved with investing in GenVec are the fact that it has a history of losses, which should continue at least for the next few years; it also faces the possibility that its drugs will never obtain FDA approval; it faces significant competition; it has a lack of resources and the company will need to obtain more capital to continue as a going concern; lastly, GenVec needs to secure a collaborative partnership to market its drugs if they do get approved by the FDA.
--Its leading candidate for FDA approval is TNFerade, which is a protein that has anti-cancer effects when combined directly with a tumor. It is currently being tested to treat pancreatic cancer, melanoma, colorectal cancer, and head and neck cancer. It is furthest along in pancreatic cancer, as the company initiated Phase III testing in 2006. It is being tested in Phase II for melanoma and colorectal cancer, and is completing Phase I testing for head and neck cancer.
--AdPEDF treats wet age-related macular degeneration by replicating a protein that naturally exists in the human eye. The drug has completed a Phase I clinical trial, and could be moving into Phase II soon.
--A pre-clinical trial drug, TherAtoh, delivers genes that produce therapeutic proteins to the inner ear. Its research is currently being focused on restoring the hearing or balance function of the ear by regenerating critical cells in the inner ear, which are called sensory hair cells.
--BioBypass has completed Phase II trials for the treatment of coronary artery disease. The research for BioBypass is in collaboration with Cordis. However, the company curtailed its testing in 2006 to focus on its other drugs. GenVec retains the development rights to BioBypass and the company says that it will "explore alternative commercialization strategies as data and circumstances warrant."
Next Post: The Potential Markets for TNFerade and AdPEDF
July 5, 2007
Posted by Sizz at 12:35 PM