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GenVec Begins Phase IIb Trials
Of TNFerade in Patients With Pancreatic Cancer
Randomized, Controlled Phase IIb Studies Now Underway: TNFerade
Data Showed 76% Tumor Response Rate Against Variety of Solid
Tumors in Phase Ib Studies
GAITHERSBURG, Maryland, July
17, 2002
GenVec, Inc., a biopharmaceutical company developing gene-based
medicines, today announced the commencement of a randomized,
controlled Phase IIb clinical trial for its lead cancer drug,
TNFerade, in patients with locally advanced pancreatic cancer.
GenVec has now initiated this 17-center Phase IIb clinical trial
of TNFerade as a first-line therapy after first reporting Phase
Ib data on TNFerade at the American Society of Clinical Oncology
(ASCO) annual meeting in May 2002.
GenVec's Phase IIb study of TNFerade
will involve approximately 140 patients and will assess the impact
of TNFerade on pancreatic cancer tumors. Key endpoints of the
study will be tumor shrinkage, time to disease progression, survival,
and quality of life. The physicians at the clinical trial sites
will also record the number of patients who may become eligible
for surgical removal of their tumor (previously classified as
inoperable) after receiving TNFerade therapy.
The Phase IIb clinical trial
of TNFerade will be divided into two parts:
- Part 1 - Dose Escalation Phase
- open-label, dose-escalating
- adds TNFerade to chemotherapeutic
agent 5FU and radiation therapy as a first-line treatment in
patients with locally advanced pancreatic cancer
- three dose levels, three to
six (3-6) patients per group; a total of up to 18 patients will
receive the drug to determine the doses(s) for the randomized
phase
- patients will receive one TNFerade
injection per week for 5 weeks while receiving standard radiation
and chemotherapy to the tumor.
Part 2 - Randomized Phase
- randomized, controlled study
where patients will be randomly allocated to standard care (5FU
+ radiation therapy) with and without TNFerade injections
- two different dose levels of
TNFerade will be tested (identified in Part 1)
- forty (40) patients per group,
a total of 120 patients, will participate in the randomized phase
of the study
In May 2002, GenVec reported
promising Phase Ib clinical data on TNFerade. Tested against
a variety of solid tumors, GenVec reported that TNFerade was
well tolerated and demonstrated a high level of objective tumor
responses including:
- 4/21 Complete Responses (100%
tumor shrinkage),
- 7/21 Partial Responses (tumor
shrinkage between 50 and 99%),
- 5/21 Minor Responses (tumor
shrinkage between 25 and 49%),
- 4/21 Stable Disease (tumor did
not grow greater than 25% of baseline size), and
- only one of the 21 evaluable
patients had Progressive Disease.
In that same study, three of the four patients with pancreatic
cancer had an objective tumor response when treated with TNFerade
plus radiation therapy. Based upon these findings, and the fact
that TNFerade has been well tolerated throughout Phase Ib studies,
GenVec commenced a Phase IIb clinical trial in patients with
pancreatic cancer.
TNFerade uses GenVec's patented
adenovector technology to deliver the tumor necrosis factor-alpha
gene directly into the tumor where it interacts with standard
radiation therapy to produce the therapeutic protein, TNF-alpha.
GenVec scientists have incorporated a radiation-inducible molecular
switch into TNFerade allowing maximum gene expression and therapeutic
protein secretion only when the target tissue receives standard
radiation therapy. With this approach, TNFerade has the potential
to make radiation therapy work better with fewer side effects.
Dr. Henrik S. Rasmussen, Senior
Vice President of Clinical Research and Regulatory Affairs for
GenVec commented on the new trial, "GenVec is pleased to
launch this trial in patients with locally advanced pancreatic
cancer. The Phase Ib data are very encouraging and provide the
justification for moving into a major randomized trial specifically
designed to answer whether TNFerade improves the prognosis of
this devastating disease."
Pancreatic cancer is among the
most deadly cancers in the western world with approximately 30,000
new cases, and 29,800 deaths, reported annually in the United
States. Less than 20% of patients with pancreatic cancer remain
alive one year after diagnosis.
GenVec is a publicly held biotechnology
company focused on the development and commercialization of novel
gene-based therapies that produce medically beneficial proteins
at the site of disease. The company combines its patented gene
transfer technologies with proprietary therapeutic genes to create
product candidates, such as BioBypass angiogen for coronary artery
disease and peripheral vascular disease, TNFerade for oncology
and AdPEDF for ophthalmology. Additional information on GenVec
is available at its web site located 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. Forward-looking statements are typically
identified by words or phrases such as "believe," "expect,"
"anticipate," "intend," "estimate,"
"assume," "plan," "outlook," "prospect,"
and variations of such words and similar expressions, or future
or conditional verbs such as "will," "would,"
"should," "could," "may," or similar
expressions. GenVec cautions that these forward-looking statements
are subject to numerous assumptions, risks and uncertainties,
which change over time. The following factors, among others,
could cause actual results to differ materially from forward-looking
statements or historical experience: risks relating to the early
stage of product candidates under development, risks relating
to GenVec's ability to identify and enter into agreements with
potential collaborative partners, uncertainties relating to clinical
trials, dependence on third parties, future capital needs, and
risks relating to the commercialization, if any, of GenVec's
proposed product candidates (such as marketing, regulatory, patent,
product liability, supply, competition and other risks). GenVec's
SEC reports identify additional factors that can affect forward-looking
statements. These forward-looking statements speak only as of
the date of this press release, and GenVec assumes no duty to
update forward-looking statements.
Press Release
SOURCE: GenVec, Inc. |
