GENVEC Biotech Smallcap mit Potenzial - 500 Beiträge pro Seite

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GenVec (GNVC) is a smallcap biotech trying to become a bigcap. Its lead product, TNFerade, is currently in a pivotal Phase II/III study [PACT] in locally advanced pancreatic cancer; Phase II studies are in progress in rectal cancer and melanoma, and Phase I/II studies are in progress in head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, seasonal and pandemic flu and foot and mouth disease. During GenVec's most recent discussions with the FDA, the FDA agreed to change the primary endpoint of the PACT trial to overall survival from one year survival.



For GenVec shareholders, this is a major plus. According to statistical analysis of the most recent data, the biggest difference in survival occurs beyond one year for patients on the current SOC. SOC patients typically expire between 6-12 months after diagnosis. Anecdotal evidence is beginning to show up in the form of message board postings and news releases.CBS in Denver did a piece on a TNFerade patient who is more than one year post treatment and is back to living his normal life. The video from this patient is currently available on YouTube (search "pancreatic cancer"). More and more patients are coming forward with their success stories of treatment with TNFerade. Its only a matter time before Wall Street and the FDA take notice.

According to the most recent press release from GenVec, the PACT trial will have a next interim look at the data after 92 events, and 184 events. The FDA could stop the trial if significant efficacy presents itself. At a first look at the data in late 2006, the TNFerade group showed an absolute response rate of 70% vs 28% SOC group. If the response rate holds at the next look in late 2008, there is no valid reason for the FDA to continue the PACT trial. It should conclude immediately and seek to approve TNFerade.

Current enrollment for the trial is approximately 130-140 patients (on average 7 patients per month). Enrollment is slow and diagnosis is difficult, often misdiagnosed for many months. I know this because a family member spent the better part of 4 months with many wrongful diagnoses, until an abdominal CT showed pancreatic cancer with liver metastasis.

As you can see, GenVec has many irons in the fire, and it appears that its PACT trial conclusion could occur within the next 12 months.

Disclosure: Author holds a long position in GNVC

www.genvec.com

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TNFERADE™ RECEIVES FDA FAST TRACK DESIGNATION
FOR TREATMENT OF PANCREATIC CANCER
Designation represents a significant regulatory achievement for TNFerade™
GAITHERSBURG, MD – November 11, 2008 – GenVec, Inc. (Nasdaq: GNVC) announced today that TNFerade™ has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. The designation is based on GenVec having “provided evidence of the potential to improve survival in patients with pancreatic cancer.”
Drugs designated for Fast Track are intended for the treatment of a life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast track designation does not apply to a product alone but to a combination of a product and specific indication. This designation provides for expedited regulatory review. Should events warrant, GenVec will be eligible to submit a U.S. biologics license application (BLA) for TNFerade on a rolling basis. Under certain conditions, this permits the FDA to review sections of the BLA prior to receiving the complete submission.
“This Fast Track designation is an important step in the increasing focus on the clinical potential of TNFerade as a treatment for locally advanced pancreatic cancer,” stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. “As further data emerge regarding TNFerade, we look forward to working closely with the FDA to potentially expedite the review process for TNFerade.”


About TNFerade™
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFα), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFα in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec’s lead product candidate, TNFerade™, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer and is being evaluated in additional clinical trials in other tumor types. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including foot-and-mouth disease, malaria, HIV, respiratory syncytial virus (RSV), HSV-2, and influenza. Additional information about GenVec is available at 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 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.

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