Date: 2013-04-01
Type of information: Submission of a clinical trial application
phase: 1
Announcement: acceptance of a Clinical Trial Application (CTA)
Company: Tengion (USA)
Product: Neo-Kidney Augment™
Action
mechanism: The Neo-Kidney Augment™ is intended to prevent or delay the need for dialysis or kidney transplantation by catalyzing the regeneration of functional kidney tissue in patients with advanced chronic kidney disease. This increase in functional kidney mass could thereby delay or prevent the need for dialysis or kidney transplant in patients with end stage renal disease (ESRD). Tengion scientists have published and presented positive data on the effect of the Company\'s Neo-Kidney Augment in four different preclinical models of CKD. Two of these preclinical models have been conducted for a sufficiently long period of time to demonstrate durability and an impact on survival.
Disease: chronic kidney disease (CKD)
Therapeutic area: Renal diseases - Kidney diseases
Country: Sweden
Trial
details: The Phase 1 trial will involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD. The trial is expected to enroll up to 5 patients in 2013 and will follow each patient for up to 2 years.
Latest
news: * On April 1, 2013, Tengion, a leader in regenerative medicine, have announced the acceptance of the Company's Clinical Trial Application (CTA) filed with the Medical Products Agency (MPA) in Sweden to initiate a Phase 1 clinical trial to evaluate the safety and delivery of its Neo-Kidney Augment™ product in up to five patients with advanced chronic kidney disease. The company expects to initiate the trial this quarter. Tengion will use the data from this trial to establish safety and a delivery approach for its planned U.S. Phase 1 trial, which the company expects to start in the fourth quarter of 2013.
This CTA acceptance follows Tengion\'s inspection by an Official Qualified Person for regulatory compliance with European Medicines Agency standards for clinical manufacturing, processes, management, and quality programs. Following the successful inspection, the Company was issued a Declaration of Compliance to enable clinical production of the Neo-Kidney Augment at its cGMP manufacturing facility located in Winston-Salem, North Carolina.
