King of Prussia, PA – April 3, 2006 – Tengion Inc. described the first successful human implantations of laboratory-grown bladders, as reported today in an article authored by Dr. Anthony Atala and others and published in The Lancet, as “a milestone that brings the promise of regenerative medicine to life.”
Tengion was founded in 2003 to develop a portfolio of neo-organs and tissues primarily focused in the genitourinary and cardiovascular fields, based largely on technology developed in the laboratories of Dr. Atala. The technology was licensed from the Children’s Hospital of Boston, Harvard’s pediatric teaching hospital. Dr. Atala is currently the director of the Wake Forest Institute for Regenerative Medicine, with which Tengion has recently entered into license and research agreements. Additional technology has been licensed from the laboratories of Drs. Langer and Vacanti at MIT.
The technology involved in the clinical experience described in The Lancet article is investigational. Further investigation of the safety and efficacy of the technology in clinical trials is necessary before it is submitted to FDA for review and consideration for approval.
Steven Nichtberger, M.D., President and CEO of Tengion, said in a statement: “The results reported in The Lancet paper represent a milestone that brings the promise of regenerative medicine to life.”
“Tengion is working with the Food and Drug Administration (FDA) to advance its transformational technology platform to bring neo-organs and tissues to patients in need. The company intends to submit an application in mid-2006 to FDA to start clinical trials later this year on our first product, the neo-bladder.”
“On the foundation of this transformational technology platform, our Company has been fortunate to have attracted top tier investors who have invested in an exceptionally experienced and passionate management team to advance our product portfolio.”
“Tengion congratulates Drs. Atala, Bauer, Soker, Yoo and Retik on the results published today. We are excited about the implications of the reported clinical experience and humbled by the opportunity to develop products that can potentially transform the field of regenerative medicine and organ transplantation.”
Tengion Inc. is a leader in developing autologous neo-organs and tissues, such as bladders, that are derived from the patient’s own (autologous) cells. Tengion’s proprietary approach to regenerative medicine has the potential to enable people with organ and tissue failure to lead healthier lives without donor transplants or the side effects of current therapies. Headquartered in King of Prussia, PA, Tengion also has research facilities located in Winston-Salem, NC. For more information, visit Tengion online at: http://www.tengion.com.