Through its unique and integrated technology platform, Tengion is researching and developing product candidates with the potential to transform the treatment of organ and tissue impairment, failure and loss. The Company's plan is to develop, manufacture, and market a suite of autologous regenerative products.
The Company's portfolio currently consists of autologous regenerative product candidates in various stages of development, with a focus on the genitourinary and cardiovascular systems.
Tengion has brought together top scientists from throughout the world who are working diligently to develop neo-organs and tissues to meet urgent human needs. While our mission is vital, we must proceed with caution. Before we can make our product candidates available, they must be proven to be safe and effective, as judged by the rigorous standards of the U.S. Food and Drug Administration (FDA).
If you have medical questions, you should discuss them with your own doctor. We cannot provide any medical guidance.
The Company has recently completed its first Phase 2 clinical trial in the United States with its Tengion Neo-Bladder Augment™ for children with neurogenic bladder due to Spina Bifida. Tengion issued a press release about this trial. A second Phase 2 trial in patients with neurogenic bladder due to spinal cord injuries has completed its enrollment. The Company plans to file an Investigational New Drug application with the Food and Drug Administration for its Tengion Neo-Urinary Conduit™ by the end of 2009, and hopes to initiate a clinical trial in patients with bladder cancer who require a total cystectomy early next year.
More information on Phase 2 clinical trials is available at www.clinicaltrials.gov.