Bottom Fish Stocks (between .10 and$10)

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GNVC - .80 This is reacting strongly in the pre-market.

11/04/2009 07:44 FDA Grants Orphan Drug Designation for TNFerade(TM)


11/04 06:44 CST
GAITHERSBURG, Md., Nov. 4 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq:
GNVC) announced today that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation to TNFerade(TM) for the treatment of pancreatic
cancer.
(Logo: http://www.newscom.com/cgi-bin/prnh/20081205/DC50112LOGO )
The FDA grants orphan drug designation to drugs that may provide a
significant therapeutic advantage over existing treatments and target
conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug
designation provides potential financial and regulatory incentives including
study design assistance, waiver of FDA user fees, tax credits, and up to seven
years of market exclusivity upon marketing approval.
"Orphan drug designation is a critical step for the development of TNFerade
and will strengthen the TNFerade program at GenVec by offering potential
clinical development and commercialization benefits," stated Dr. Paul Fischer,
GenVec's President and CEO.
About TNFerade(TM)
TNFerade, which has not yet been approved for use, is an adenovector, or DNA
carrier, which contains the gene for tumor necrosis factor-alpha (TNF-alpha),
an immune system protein with potent and well-documented anti-cancer effects,
for direct injection into tumors. After administration, TNFerade stimulates the
production of TNF-alpha in the tumor. 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.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic
drugs and vaccines. GenVec's lead product, TNFerade(TM), is currently in a
pivotal clinical study (PACT) in locally advanced pancreatic cancer. TNFerade
has also been and is currently being evaluated for its potential use in the
treatment of several other cancers, including esophageal cancer, rectal cancer,
and head and neck cancer. 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 HSV-2.
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.
Investor Contact: Media Contact:
GenVec, Inc. Tiberend Strategic Advisors, Inc.
Danielle M. DiPirro Andrew Mielach
[phone] [phone]
[e-mail] [e-mail]
SOURCE GenVec, Inc.
(TS:GNVC;)