Tengion (NSDQ:TNGN) plans to complete enrollment its in Neo-Urinary Conduit clinical trial following the deaths of 2 of the 6 enrolled patients after deeming the deaths unrelated to the device or surgical procedure.
"We are deeply saddened to hear of the passing of these 2 patients," Tengion president & CEO John Miclot said in prepared remarks. "We are grateful for their trial participation, which provided key insights into the safety and potential effectiveness of the Neo-Urinary Conduit, including its patency and functionality, a successfully redefined surgical procedure, a robust post-operative recovery, and the resilience of this product candidate to aggressive chemotherapeutic regimens."
The 4th patient enrolled in the trial died of metastasis bladder cancer that failed to respond to chemotherapy and radiation, the company reported. The Neo-Urinary Conduit functioned well and helped the patient maintain normal renal function until the time of his death, Tengion reported.
The trial’s 6th patient died of a heart attack unrelated to the trial. The patient had a functioning Neo-Urinary Conduit and showed normal renal function at the time of his 6-week post-operative follow-up, according to a company statement.
Tengion’s Neo-Urinary Conduit is a bioabsorbable scaffold combined with a patient’s own cells to form a urinary tissue conduit to passively transport urine through a hole in the abdomen into a standard ostomy bag. The device is in the midst of a Phase 1 trial in bladder cancer patients who need urinary diversion following bladder removal.
"We are diligently working toward executing on our key clinical objectives for this program, namely to recruit the remaining 4 patients in this trial and complete implantation of up to 10 patients by the end of this year," Miclot said.
TNGN shares sank hard today, losing 14.3% by about 10:30 a.m. when they were going for about 90¢ apiece.
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