Healthcare Industry News: TYGACIL
News Release - July 7, 2010
Tengion Appoints Sunita B. Sheth, M.D., Chief Medical OfficerIndustry Veteran Brings Successful Track Record in Clinical Development of Novel Therapeutics
EAST NORRITON, Pa., July 7 (Healthcare Sales & Marketing Network) -- Tengion Inc. (Nasdaq:TNGN ) today announced that it has appointed Sunita B. Sheth, M.D., to the position of Chief Medical Officer, Vice President, Clinical and Regulatory Affairs. In this role, Dr. Sheth will be responsible for developing clinical development strategies, implementing clinical trials, and providing clinical translation insights to preclinical pipeline programs.
"We are extremely pleased to add Dr. Sheth to the Tengion team," stated Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion. "Her broad experience in multiple therapeutic areas, deep knowledge of early and late stage clinical development, and commitment to patient care will be invaluable to Tengion as we continue to advance our platform and product candidates."
Dr. Sheth most recently served as Vice President, Specialty Care Business Unit, for Pfizer as part of its acquisition of Wyeth. Prior to that, she spent four years at Wyeth, most recently as Vice President, Cardiovascular, Metabolic and Infectious Diseases. Before joining Wyeth, she held positions of increasing responsibility at AstraZeneca and GlaxoSmithKline since joining the industry in 1997. Her pharmaceutical development leadership experience covers multiple therapeutic areas and phases of development including approval of several INDs for drugs as well as the biologics FIX mab and OAP-189; the global regulatory submission of ximelagatran for multiple indications; and approval of an sNDA for TYGACIL.
"This is an exciting time for Tengion and I am very much looking forward to working closely with the management team to advance the company's pipeline," stated Dr. Sheth. "Tengion's Organ Regeneration Platform™ provides a unique opportunity to bring novel therapies and clinical advances to patients in need."
Dr. Sheth earned her B.A. and M.D. degrees from Brown University and completed fellowships in Hematology/Oncology at Brown and Temple University. She maintains an adjunct professorship at Temple University Medical School.
Tengion's lead program, the Neo-Urinary Conduit™, is currently in a Phase 1 clinical trial in patients with bladder cancer. Tengion expects to report key data for its lead discovery program, the Neo-Kidney Augment™, later this year.
Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform that enables us to create proprietary product candidates that are intended to harness the intrinsic regenerative pathways of the body to produce a range of native-like organs and tissues. Our product candidates seek to eliminate the need to utilize other tissues of the body for a purpose to which they are poorly suited, procure donor organs or administer anti-rejection medications. Tengion commenced a Phase I clinical trial in March 2010 for its lead product candidate, the Neo-Urinary Conduit™, an autologous implant that is intended to catalyze regeneration of native-like bladder issue for bladder cancer patients requiring a urinary diversion following bladder removal. Tengion has also applied its technology in two Phase II clinical trials for Tengion's Neo-Bladder Augment™ for the treatment of neurogenic bladder. Tengion has worldwide rights to its product candidates.
Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to: (i) our plans to develop and commercialize our product candidates, including our Neo-Urinary Conduit; and (ii) our ongoing and planned preclinical studies and clinical trials. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company's business is subject to significant risk and uncertainties, and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: (i) we may have difficulty enrolling patients in our clinical trials, including our Phase I clinical trial for our Neo-Urinary Conduit; (ii) patients enrolled in our clinical trials may experience adverse events related to our product candidates, which could delay our clinical trials or cause us to terminate the development of a product candidate; and (iii) we may be unable to progress our product candidates that are undergoing preclinical testing into clinical trials. For further information with respect to factors that could cause the company's actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or expectations contained in this release.
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