CEO Interview: GenVec, Inc. - Dr. Paul H. Fischer

• On 4:08 pm EDT, Tuesday October 20, 2009

67 WALL STREET, New York - October 20, 2009 - The Wall Street Transcript has just published its Biotechnology Report offering a timely review of the sector to serious investors and industry executives. This 70-page feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Heightened M&A Activity - Trend Toward Orphan Disease Drug Development - Generic Drug Competition - Current Length Of FDA Approval Process - Ownership Ego Preventing Shareholder Returns - IPO And Secondary Offering Window Opening - Big Pharma R&D Pipeline - Decreased Clinical Development Risk - Impact Of Health Care Reform - Convergence Of Large-Cap Biotech And Pharmaceutical Companies - Easier Credit For Small Cap Biotech Companies - Developments In Cancer Chemotherapeutics - Gene Delivery Technology

Companies include: ADVENTRX (ANX); Abbott Labs (ABT); Advaxis (ADVX); Amedisys (AMED); Amgen (AMGN); Amylin Pharmaceuticals (AMLN); Antares Pharma (AIS); BioDelivery Sciences (BDSI); Biogen Idec (BIIB); Biomarin (BMRN); Boston Scientific (BSX); Bristol Myers (BMY); CVS Caremark (CVS); Celgene (CELG); Cerner (CRN); Cerus (CERS); Coke (KO); CombiMatrix (CBMX); Coventry Health Care (CVH); DARA (DARA); Eisai (ESALY); Eli Lilly (LLY); GenVec (GNVC); Gilead (GILD); GlaxoSmithKline (GSK); Health Management Associates (HMA); Human Genome Sciences (HGSI); Inspire Pharmaceuticals (ISPH); Intellect Neurosciences (ILNS.OB); InterMune (ITMN); International Stem Cell (ISCO.OB); Javelin Pharmaceuticals (JAV); Johnson & Johnson (JNJ); Keryx Biopharmaceuticals (KERX); Kraft (KFT); MAP Pharmaceuticals (MAPP); Medco (MHS); Merck (MRK); Merit Medical (MMSI); Novartis (NVS); Novelos (NVLT.OB); Novo Nordisk (NVO); Nutrisystem (NTRI); OSI Pharmaceutical (OSIP); Orexigen (OREX); Pepsi (PEP); Pfizer (PFE); Rite Aid (RAD); Schering-Plough (SGP); Takeda (TKPHF); Teva Pharmaceuticals (TEVA); Viropro (VPRO.PK); Walgreens (WAG); Wyeth (WYE); XOMA (XOMA); ZIOPHARM (ZIOP).

In the following brief excerpt from the 70-page report, Dr. Paul H. Fischer, CEO of GenVec, Inc., discusses the outlook for the sector and for investors.

TWST: Tell us a little bit about GenVec.

Dr. Fischer: GenVec (GNVC) was founded in 1992 to explore the potential of gene-based medicines, which was a very forward-looking concept back then. From the outset, we have tackled difficult problems because we believe the new technology should address hard-to-meet medical needs. Those have included things such as new cancer treatments and, more recently, efforts to prevent infectious diseases. It's really gratifying for us now to have our lead product candidate, TNFeradeª, now in Phase III testing in pancreatic cancer, a disease for which there is no effective therapy. In addition, we've had substantial efforts - all of which are supported by outside funding focused on the application of our core adenovector technology - for the development of new vaccines. These programs are important to us for multiple reasons: They reduce our cash needs because they are fully funded; they also accelerate the development of new technology, which has been critical for us to stay ahead of our competitors and generate new product opportunities. That portion of the businesses is doing well and has continued to grow over the last several years. Most recently, we've had a leading-edge program in hearing loss emerge. This program is also based on our core gene delivery technology. Hearing loss is a major problem without effective drug therapy, and we are excited about the potential our technology has to address this serious unmet medical need.

TWST: One of the technologies you have is adenovector. What is that?

Dr. Fischer: First, I'd like to explain the clinical problem, and then I'll tell you how our technology solves it. There is a potent protein, tumor necrosis factor-alpha (TNF-alpha), known to stimulate the immune system and have significant anti-tumor properties. For a number of years it was studied clinically, but when the protein was given in the bloodstream it would cause too many harmful side effects to be useful. Thus, the protein looked promising but because of drug delivery problems, it couldn't be used effectively. Our goal was to find a way to solve the TNF-alpha toxicity problem. Through our innovative technology, we were able to deliver the gene to the tumor. Delivery of the gene allows cells in the tumor to produce TNF-alpha locally at the site of the disease without leading to high levels of TNF-A in the bloodstream. With this technology, we are able to express the anti-cancer protein without the toxicity that could occur when TNF-alpha is administered in the bloodstream. This is an example of how GenVec's technology can be used - a gene stimulates the production of a protein locally, creating a therapeutic effect without toxicity.

TWST: Why is this particularly beneficial for pancreatic cancer?

Dr. Fischer: TNFerade is particularly useful in pancreatic cancer because we are able to deliver a very strong anti-cancer protein to fight a very serious tumor without major side effects for the patients. We combine this treatment with the best available therapy, which is radiation combined with a drug known as fluorouracil, and then follow it with treatment of the metastatic disease with another chemotherapy drug called gemcitabine. The results to date have supported the concept that improved local therapy would, in fact, show better overall survival in patients with locally advanced pancreatic cancer. We're very encouraged that TNFerade appears to help control pancreatic cancer and improve survival in those suffering from this hard-to-treat disease.

TWST: What kind of reception are you getting for the cancer therapies?

Dr. Fischer: People are extremely interested in GenVec's cancer therapies because for many of these diseases the standard treatments haven't worked well, and the results of our trials have been promising. Additionally, scientists, oncologists and patients are all seeking less toxicity in cancer treatments, which makes TNFerade - a treatment that doesn't seem to add significant toxicities to the standard therapy - very appealing.

TWST: What made you decide to look at the problem of hearing loss?

Dr. Fischer: Researchers recognized that critical cells in the inner ear were not able to regenerate after being damaged. When we learned of a protein that could regenerate these cells, we realized that if we could somehow deliver the gene that coded for the protein, regeneration of these cells may be possible. We really believe - and continue to be encouraged by the early data we've seen in animal models - that our technology has the potential to be groundbreaking in this field.

TWST: When will we see that therapy on the market?

Dr. Fischer: It is very difficult to project that. It typically takes 10 years for clinical trials and FDA approval. We are encouraged by the wonderful animal data that we've seen in hearing loss, and we're in business discussions with companies about hearing loss. It might be possible to get into initial early clinical testing possibly within a couple of years because the proof of concept looks very powerful. But there are a lot of steps in terms of manufacturing and safety study, so it is difficult to project an exact time frame. However, we are confident this technology will see the clinic, and we hope to see promising results.

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