Tengion, a clinical-stage biotechnology company, is a leader in developing neo-organs and tissues derived from a patient's own (autologous) cells. The Company's lead product candidate, the Tengion Neo-Bladder™, is currently in Phase II clinical trials in the United States in pediatric patients with spina bifida, adult patients with spinal cord injury and adult patients with urge incontinence. A successful academic human clinical experience with a urinary Neo-Bladder was reported in The Lancet in April 2006 by investigators from the Children's Hospital Boston.
The Company's patented integrated technology platform - which was developed over the past two decades by scientists at Children's Hospital Boston (a teaching affiliate of Harvard Medical School), MIT, Wake Forest Institute for Regenerative Medicine, and Tengion - represents a breakthrough in regenerative medicine. The technology harnesses the body's ability to regenerate tissues and organs, and has the potential to allow adults and children with organ failure to have functioning organs created from their own tissues. This can potentially enable them to lead healthier lives without the need for donor transplants, which are in limited supply and can be associated with adverse effects of immunosuppression.
Tengion's technology platform supports a broad potential product portfolio and provides the Company the opportunity to address multiple tissues and organs in the genitourinary and cardiovascular systems. The product candidates being developed by Tengion are solely focused on important unmet clinical needs where our technology can offer a unique and compelling medical advance. The Company's robust technology and targeted business model provide a foundation from which the Company believes it can effectively surmount challenges that have previously been encountered in the field of regenerative medicine. With the Tengion Neo-Bladder in Phase II clinical trials, Tengion has an opportunity to be first to bring a product to the marketplace in the field of autologous organ regeneration.
Tengion launched its first Neo-Bladder Phase II clinical trial, the first to study a regenerated human organ, in 2006, as planned. A second Phase II clinical trial on the Neo-Bladder was launched in 2007. The study is being conducted under an FDA-accepted IND (investigational new drug application). The Neo-Bladders for patients in this trial are being developed at Tengion's pilot manufacturing facility. The third Phase II clinical trial was launched January, 2008.
The Company has licensed over 60 US and International patents and patent applications from Harvard's Children's Hospital Boston and MIT, emanating largely from the work of the company's scientific founder, Dr. Anthony Atala. An internationally recognized expert in the field of regenerative medicine, Dr. Atala conducted research and practiced pediatric urology at Harvard's Children's Hospital Boston for 15 years, until 2003, when he became Director of the Wake Forest Institute for Regenerative Medicine in North Carolina. Dr. Atala's numerous awards and honors include the Christopher Columbus Foundation Award, funded by the US Congress and bestowed on a living American whose discoveries will significantly benefit society; and the Scientific American, Research Leader Award, for his contributions to tissue and organ regeneration.
Tengion's management team is led by Steven Nichtberger, M.D., who has brought together leaders from the top echelons of the pharmaceutical, device, and biotechnology industries. They are guided by a vision to bring transformational medical technology to patients in need of tissue and organ repair.
Tengion's corporate headquarters and commercial manufacturing facility are in East Norriton, Pennsylvania. The company has research offices, a development laboratory and a pilot manufacturing facility in Winston-Salem, North Carolina.
Our mission is to transform the lives of patients in need of an organ transplant or augmentation by developing autologous neo-organs and tissues that harness the regenerative power of the patient's own healthy tissue, enabling it to restore vital functions.
This is the reason we get to work early every morning - there's a death every thirty seconds from organ failure. As I write this letter, there are 99,285 Americans on the waiting list for donor organs, and if they are fortunate enough to find one, they will face a lifetime of treatment to suppress their immune systems to prevent rejection.