Printer Friendly
The Free Library
14,380,430 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

GenVec Receives Clearance From FDA for EUS Administration of TNFerade(TM).


PACT Study to Include EUS Endoscopic ultrasonography (EUS)
A medical procedure in which sound waves are sent to the stomach wall by an ultrasound probe attached to the end of an endoscope.
 Centers

GAITHERSBURG, Md. -- GenVec, Inc. (Nasdaq: GNVC) today announced that it has reached agreement with the U.S. Food and Drug Administration to proceed with endoscopic ultrasound Endoscopic ultrasound (EUS)
A medical procedure in which sound waves are sent to the stomach wall by an ultrasound probe attached to the end of an endoscope.
 administration (EUS) of TNFerade[TM] as an additional option to percutaneous injection (PTA PTA or parent-teacher association: see parent education. ) for patients participating in its pivotal clinical trial for locally advanced pancreatic cancer (PACT).

"We are pleased to have received clearance from FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 for EUS administration of TNFerade," stated Mark Thornton, M.D., Ph.D, GenVec's senior vice-president of product development. "The addition of EUS may positively impact the recruitment of new centers and patients, and we look forward to enrolling the first EUS patient in this clinical trial."

About TNFerade[TM]

TNFerade is an adenovector, or DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 carrier, which contains the gene for tumor necrosis factor-alpha Tumor necrosis factor (TNF, cachexin or cachectin and formally known as tumor necrosis factor-alpha) is a cytokine involved in systemic inflammation and is a member of a group of cytokines that all stimulate the acute phase reaction.  (TNFa), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFa in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.

About PACT

GenVec's PACT trial is a multi-center, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, active and controlled study targeted to enroll 330 patients, designed to evaluate the safety and efficacy of TNFerade plus standard of care (SOC) versus standard of care alone in patients with locally advanced pancreatic cancer.

About GenVec

GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of the Company's therapeutic product candidates uses a common patent-protected technology platform to deliver genes that produce medically beneficial proteins directly at the site of disease. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , malaria, seasonal and pandemic pandemic /pan·dem·ic/ (pan-dem´ik)
1. a widespread epidemic of a disease.

2. widely epidemic.


pan·dem·ic
adj.
Epidemic over a wide geographic area.

n.
 flu, and foot and mouth disease a contagious disease (Eczema epizoötica) of cattle, sheep, swine, etc., characterized by the formation of vesicles and ulcers in the mouth and about the hoofs.

See also: Foot
. Additional information about GenVec and its portfolio of product candidates 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 programs and studies, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and . 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 relating to the early stage of GenVec's product candidates under development; uncertainties with, and unexpected results and related analyses relating to clinical trials of GenVec's product candidates including the length of time required to enroll suitable patient subjects and our ability to secure clinical trial sites; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or collaborators; 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); dependence on the efforts of third parties; dependence on intellectual property; the amount of revenues attributable to Genvec's vaccine program; and risks that we may lack the financial resources and access to capital to fund our operations during the lengthy periods required to develop product candidates. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jan 11, 2007
Words:595
Previous Article:Nighthawk Systems Receives Order from Rice University.
Next Article:IBM Sets Record for Most U.S. Patents Earned in One Year.
Topics:



Related Articles
GenVec Begins Phase II Melanoma Study with TNFerade(TM).
TNFerade(TM) Reduces Metastasis in Animal Model of Melanoma; Findings Presented at AACR Support Rationale for Current Phase II Testing.
Long-Term Results from TNFerade(TM) Pancreatic Cancer Study and Updated Survival Results from TNFerade(TM) Esophageal Cancer Study Both Reported at...
GenVec Announces Completion of Interim Safety Data Analysis for Phase II/III Trial with TNFerade(TM) in Pancreatic Cancer.
GenVec Announces Efficacy Update in Phase II/III Clinical Trial of TNFerade(TM) in Locally Advanced Pancreatic Cancer.
GenVec Announces First Patient Treated with TNFerade(TM) for Head and Neck Cancer at University of Chicago.
GenVec Announces New Research at AACR on Selectivity and Mechanism of Action of TNF-Based Anti-Cancer Therapy.
GenVec Reports First Quarter 2007 Financial Results.
GenVec Signs Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID) to Develop...
GenVec Announces Update of Safety and Efficacy Data from Pivotal Phase II/III PACT Study of TNFerade(TM) at ASCO.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles