-- Expansion Planned for Neo-Kidney Augment™ Swedish Phase 1 Clinical Trial to Include Ten Additional Patients; U.S. Phase 1 Clinical Trial Initiated --
-- Neo-Urinary Conduit™ U.S. Phase 1 Clinical Trial to Complete Patient Enrollment --
WINSTON-SALEM, N.C., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Tengion, Inc. (OTCQB:TNGN), a leader in regenerative medicine, today announced continued clinical progress in its two lead programs, the Neo-Kidney Augment and the Neo-Urinary Conduit.
The Neo-Kidney Augment, which is intended to prevent or delay dialysis and transplantation by increasing renal function in patients with advanced chronic kidney disease (CKD), was implanted in five CKD patients in 2013 in the ongoing Phase 1 clinical trial in Sweden. The Neo-Kidney Augment is safe and well tolerated in the five patients implanted to date. The Company now plans to expand enrollment in this trial to 15 patients. The Company also announced the initiation of a Phase 1 clinical trial in the U.S. under an open Investigational New Drug (IND) application for the Neo-Kidney Augment. Tengion will also complete patient enrollment in the ongoing U.S. Phase 1 clinical trial for its second lead program, the Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like urinary tissue for bladder cancer patients requiring a urinary diversion following bladder removal.
"Our lead clinical programs have continued to make progress, placing Tengion at the forefront of regenerative medicine," commented John L. Miclot, President and Chief Executive Officer of Tengion. "We believe that the Neo-Kidney Augment product has the potential to provide tremendous advantages for patients suffering from CKD and that there is great need for this important product candidate. The planned enrollment expansion in Sweden and the initiation of U.S. clinical development is very encouraging. We also expect to move forward with the Neo-Urinary Conduit by engaging key opinion leaders and the U.S. Food and Drug Administration (FDA) and for guidance on next phase trials by mid-2014, and we believe the product has the potential to be the new standard of care for bladder cancer patients following bladder removal."
Neo-Kidney Augment Program Update
The Phase 1 trial of the Neo-Kidney Augment being conducted at the Karolinska Institute in Stockholm, Sweden commenced in May 2013 and involves delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD. The Neo-Kidney Augment is safe and well tolerated in the five patients implanted to date. As noted above, the Company plans to expand enrollment to 15 patients, and all patients in the trial will be followed for up to two years.
The recently initiated U.S. Phase 1 clinical trial will evaluate the safety and delivery of the Company's Neo-Kidney Augment in patients with CKD. It is expected to enroll up to 12 patients and will follow each patient for up to two years. The Company anticipates that it will complete patient enrollment during 2014.
Neo-Urinary Conduit Program Update
Tengion will complete patient enrollment in the ongoing Neo-Urinary Conduit Phase 1 clinical trial and plans to engage key opinion leaders and the FDA for guidance on potential next phase trials by mid-2014. The ongoing Phase 1 trial is designed to translate the surgical procedure successfully used in preclinical animal models into clinical trials with human patients, as well as to assess the safety and preliminary efficacy of the Neo-Urinary Conduit.
About the Neo-Kidney Augment™
The Neo-Kidney Augment is an implant made from a patient's own cells and is intended to catalyze the regeneration of functional kidney tissue in patients with advanced chronic kidney disease (CKD). This increase in functional kidney mass could thereby prevent or delay the need for dialysis and transplant in patients with advanced chronic kidney disease (CKD). According to the United States Renal Data System, there are approximately 26 million adults in the U.S. who have CKD and 100,000 new patients who start on dialysis each year. CKD affects more than 10% of the world's population. Additionally, $39 billion in direct U.S. costs each year are attributable to patients with end-stage renal disease, which is associated with an approximate 20% mortality rate per year and an average life expectancy of a patient initiating dialysis of approximately four years.
About the Neo-Urinary Conduit™
Tengion's Neo-Urinary Conduit is designed to replace the standard of care for bladder cancer patients undergoing cystectomy (removal of bladder). There are over 25,000 cystectomies performed annually in bladder cancer patients in the U.S. and Europe. The Neo-Urinary Conduit is an implant made from a patient's own cells and is intended to catalyze regeneration of native-like urinary tissue, thereby eliminating the need to use bowel tissue in the current standard of care surgery. The Neo-Urinary Conduit is expected to eliminate the short-term and long-term complications associated with use of bowel tissue, such as electrolyte and metabolic disorders, nutritional and therapeutic-agent absorption anomalies, kidney and urinary tract infections, and stone formation. In addition, the Neo-Urinary Conduit is anticipated to improve recovery times, which results in faster hospital discharges compared to the current standard of care.
About Tengion
Tengion, a clinical-stage regenerative medicine company, is focused on developing its Organ Regeneration Platform™ to harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues with the goal of delaying or eliminating the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. The Company is currently conducting Phase 1 clinical trials in Sweden and the U.S. for its Neo-Kidney Augment, which is intended to prevent or delay dialysis and transplantation by increasing renal function in patients with advanced chronic kidney disease.
A Phase 1 trial for the Company's Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like urinary tissue for bladder cancer patients requiring a urinary diversion following bladder removal, is ongoing.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Tengion's plans, potential opportunities, or other expectations, projections, goals, objectives, strategies, timelines, clinical studies, product development and the potential benefits of its products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Tengion's operating performance and financial position, research, development and commercialization of products, the risks and uncertainties associated with meeting the objectives of its clinical studies, including, but not limited to, continued funding, delays or failures in enrollment, and the occurrence of adverse safety events, obtaining regulatory approvals, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.