From rxpgnews.com
TNFerade(TM) to be Studied for Locally Advanced Pancreatic Cancer Using Electronic Data Capture Solution
By Phase Forward,
May 10, 2005 - 8:39:38 PM
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that GenVec, Inc. (NASDAQ: GNVC) has selected Phase Forward's InForm(TM) electronic data capture (EDC) solution to manage a randomized, controlled Phase II clinical trial of its investigational oncology drug, TNFerade(TM).
The trial will assess the clinical benefit of using TNFerade in combination with standard care treatment in patients with locally advanced pancreatic cancer.
GenVec will leverage the InForm solution via Phase Forward's ASP hosting service to obtain direct, real-time access to clinical data and improve the efficiency and quality of clinical trial data collection and management.
GenVec is a biopharmaceutical company focused on the development and commercialization of novel therapies that improve patient care in the areas of cancer and cardiac disease, and to prevent vision loss. Each of GenVec's investigational drugs utilizes the same approach - localized production of a therapeutic protein at the site of disease.
TNFerade causes the production of Tumor Necrosis Factor-Alpha (TNF-alpha) directly within the tumor and is intended for use with standard chemotherapy and/or radiation to improve the clinical outcome for patients. Pancreatic cancer, which is very hard to control with current treatments and can be cured only when it is found at an early stage, is currently the lead indication for TNFerade.
Biopharmaceutical companies like GenVec continue to search for innovative ways to approach clinical data management. Prior to selecting Phase Forward's InForm solution to assist in the trial, GenVec relied on traditional paper-based methods for data collection and management. "It is important that we carefully evaluate technology vendors to ensure that we select a partner that understands our business requirements and is flexible enough to meet our specific needs," said Jennifer Drescher, clinical operations manager at GenVec. "We selected Phase Forward because of its market leadership, experience serving both large and small biopharmaceutical companies in various therapeutic areas, and superior product functionality. The GenVec/Phase Forward team put forth a tremendous effort to not only meet tight deadlines for EDC implementation, but achieve them ahead of schedule."
During the five week treatment period, patients randomized to receive TNFerade will receive chemotherapy and radiation plus a weekly intratumoral injection of TNFerade, followed by gemcitabine maintenance; control patients will receive chemotherapy and radiation alone, followed by gemcitabine maintenance. Progression-free survival, shrinkage of the primary tumor, surgical resectability of the primary tumor following treatment, and overall survival will all be assessed.
InForm will allow GenVec to expedite the collection of high quality data, enhance the execution and management of the TNFerade trial, and improve and accelerate clinical decision-making. Utilizing Phase Forward's ASP hosting service enables GenVec to reap the benefits of EDC without the delays or costs associated with a full on-site technology implementation.
"The American Cancer Society estimates that over 32,000 people will be diagnosed with pancreatic cancer this year, and unfortunately, nearly all of them will die of their disease. Although pancreatic cancer is the fourth leading cause of cancer deaths in men, and the fifth in women, very little headway has been made in terms of prolonging the expected survival of pancreatic patients during the past decade. Phase Forward is honored to serve as GenVec's technology partner in this effort to test a new approach to treating patients suffering from this devastating disease," said Bob Weiler, president and CEO of Phase Forward.
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