EAST NORRITON, Pa., Oct. 27 /PRNewswire/ -- Tengion, Inc. (Nasdaq: TNGN), a leader in regenerative medicine, reviewed pipeline progress at its first Analyst and Investor Meeting which was held today in New York City. The event featured updates and discussions of milestones and key data for the Company's Neo-Urinary Conduit™ and Neo-Kidney Augment™ programs. An audio archive of the event and presentation materials will be available at the Investors section of the Tengion website at www.tengion.com.
Neo-Urinary Conduit Bladder Cancer Trial – Clinical Update
The Company's Neo-Urinary Conduit was recently implanted in the first patient as part of the ongoing initial clinical trial evaluating the Company's lead product candidate in bladder cancer patients requiring a urinary diversion following bladder removal. The patient is being treated at the University of Chicago Medical Center by the principal investigator at the site for this study, Gary D. Steinberg, M.D., Professor of Surgery and Director, Urologic Oncology. The trial is also being conducted at The Johns Hopkins Hospital in Baltimore, Maryland.
"We are very pleased that investigators have identified, enrolled, biopsied, and implanted the first patient with our regenerative Neo-Urinary Conduit," stated Sunita Sheth, M.D., vice president and chief medical officer. "With the first implant completed and two sites actively screening patients, we and our investigators are optimistic that the pace of enrollment will accelerate."
Neo-Kidney Augment Program Update
The Neo-Kidney Augment is the Company's lead preclinical program and is intended to prevent or delay the need for dialysis or kidney transplant by increasing functional renal mass in patients with advanced chronic renal disease, a significant unmet medical need. Tengion has now published or presented consistently positive data on the effect of its approach on kidney function in four different animal models of chronic kidney disease. Two of the models have been conducted for a sufficiently long period of time to demonstrate durability at six months and one year, long enough to impact survival.
- In October 2010, Tengion presented new research data in a podium presentation at the American Society for Transplantation's Annual Scientific Exchange in Orlando, FL. The presentation highlighted early data from a canine model of chronic kidney disease demonstrating promising improvements in kidney function with a regenerative autologous cellular therapy approach to increase kidney mass and improve kidney function. Specifically, the presented data showed improvements in kidney filtration, protein balance, and weight gain in treated animals compared to a control group. Effects in a pilot study have persisted through the first three months after treatment. A follow-up study has demonstrated efficacy as early as seven weeks after implantation. The studies are designed to monitor progression over a six-month period and both studies are ongoing. Tengion expects to announce further results from this study later in the fourth quarter of 2010.
- In September 2010, Tengion presented one-year follow-up data from the Neo-Kidney Augment program in a podium presentation at the 2nd Annual Symposium on Stem Cell Translation of the International Society for Cellular Therapy in San Francisco. The presentation highlighted new results demonstrating success with the Company's targeted autologous cellular therapy approach to kidney regeneration in a widely accepted rodent model of obesity, diabetes and hypertension. At one year of age, the treated animals were reported to have demonstrated improved kidney function, delayed disease progression, and better survival compared to the age- and disease-matched untreated control animals. In addition, blood pressure was significantly reduced in these animals. The study is continuing as planned.
- Also in September 2010, Tengion announced the publication of a key study in the American Journal of Physiology Renal Physiology by researchers at Tengion. In the study, rodents with chronic kidney disease were treated with healthy kidney cells to catalyze the regeneration of functional kidney tissue and delay disease progression, as evidenced by extended survival, improved kidney filtration, and reduced severity of kidney tissue pathology.
"We are making significant progress in our renal program. In a series of aggressive animal models of renal failure, the Neo-Kidney Augment product candidate is consistently demonstrating the ability to stabilize and preserve renal function. We look forward to presenting additional data at scientific sessions later this year," said Tim Bertram, DVM, Ph.D., executive vice president and chief scientific officer of Tengion.
Tengion, a clinical-stage biotechnology company, has pioneered the Organ Regeneration Platform™ that enables the Company 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. Tengion's 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. An initial clinical trial is ongoing for the Company's lead product candidate, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal. The Company's lead preclinical candidate is the Neo-Kidney Augment™ which is designed to delay or prevent the need for dialysis or transplantation in patients at risk for kidney failure. 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 the Company's: (i) plans to develop and commercialize its product candidates, including the Neo- Kidney Augment and the Neo-Urinary Conduit; and (ii) expectations regarding ongoing and planned preclinical studies and clinical trials. Although Tengion believes that these statements are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there are a number of factors that may cause actual results to differ from these statements. For instance there can be no assurance that: (i) the Company will be able to obtain the capital it needs to develop its product candidates or continue as a going concern; (ii) the Company will be able to successfully enroll patients in its clinical trials, including its Phase I clinical trial for the Neo-Urinary Conduit; (iii) patients enrolled in the Company's clinical trials will not experience adverse events related to the Company's product candidates, which could delay clinical trials or cause the Company to terminate the development of a product candidate; (iv) the results of the clinical trial for the Neo-Urinary Conduit will support further development of that product candidate; (v) data from the Company's ongoing preclinical studies will continue to be supportive of advancing its preclinical product candidates; and (vi) the Company will be able to progress its product candidates that are undergoing preclinical testing, including the Neo-Kidney Augment, into clinical trials. For additional factors which could cause actual results to differ from expectations, reference is made to the reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward looking statements in this release are made only as of the date hereof and the Company disclaims any intention or responsibility for updating predictions or expectations in this release.
SOURCE Tengion, Inc.