Great news out of Tengion (Nasdaq: TNGN), the Winston-Salem regenerative medicine pioneer.
The company says it has successfully implanted the seventh of a planned 10 patients in its ongoing Phase 1 clinical trial testing the safety of its Neo-Urinary Conduit. Tengion plans to have the lab-grown urinary tissue implanted in the other three trial patients by April.
Tengion also has filed an application with Swedish authorities to start human testing of its “kidney seeds” technology called the Neo-Kidney Augment. The company plans to start testing the kidney-saving potential of the regenerative procedure in five patients with chronic kidney disease in Sweden this spring.
Tengion plans to file for U.S. Food and Drug Administration approval to test the kidney process in the United States in the fourth quarter of 2013.
“We are confident that both our lead products have very strong potential to be the new standards of care and we are eager to execute on our anticipated milestones in the coming months,” said John Miclot, Tengion’s president and CEO.
Tengion moved its headquarters from Pennsylvania to Winston-Salem in early 2012.
The company, and the nearby Wake Forest Institute for Regenerative Medicine have been key figures in putting North Carolina in a global leadership position for commercializing this amazing new “grow-your-own replacement parts” technology.
[In other news Monday, Tengion reported that it had won approval from investors for a two-week delay in a $500,000 interest payment due on Feb. 1 that was tied to a $15 million private placement raised last October.
[Tengion shares closed at $1.36 Monday. Its shares have ranged from a low of 87 cents to a high of $7.30 over the past year.]
(C) NC Biotechnology Center
