Tengion says it needs more time to enroll patients for clinical trial
Dec 03, 2012 (Menafn - Winston-Salem Journal - McClatchy-Tribune Information Services via COMTEX) --Tengion Inc. said in a regulatory filing today it will need to go past the end of 2012 to complete the enrollment of patients in a pivotal clinical trial.
The Winston-Salem regenerative-medicine company is developing a neo-urinary conduit to help patients with a bladder disorder divert urine through the use of their own cells to an external bag rather than through bowel tissue.
The goal is to help bladder cancer patients. Tengion had enrolled six of the 10 patients required for the Phase 1 clinical trial.
However, the company said Oct. 26 that two patients died from complications not related to the trial.
"In light of the anticipated timing of enrolling patient seven in this trial, the company anticipates it will complete enrollment of the remaining patients during the first quarter," the company said in a regulatory filing.
John Miclot, Tengion's president and chief executive, had said as recently as Nov. 13 that Tengion was confident of enrolling the remaining four patients by year-end.
For more than 20 months, Tengion has been in a race to achieve a clinical breakthrough with its kidney and urinary research -- thus bolstering investor confidence -- before its capital runs out.
Tengion is best known for the research of Anthony Atala, its founder, who runs the Wake Forest Institute for Regenerative Medicine. The company has cut back significantly on expenses, including eliminating 30 of its 52 jobs in November.
It has had several important updates in the past two months that include:
-- Securing 15 million in make-or-break debt financing from at least five named investors.
-- Providing a new investor, Celgene Corp., with the first shot at licensing its most promising research as part of the debt financing.
-- Requesting shareholder permission to increase its number of shares by more than eightfold, or from 90 million shares to 750 million shares.
-- Reporting moving a step closer to receiving a patent for its neo-urinary conduit and its neo-kidney augment for treating advanced chronic kidney disease.
Tengion is trying to get Food and Drug Administration approval for an "investigational new drug" for its neo-kidney augment in the first half of 2013.
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