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Bladder-builder welcomes windpipe
Posted by Alison McCook
[Entry posted at 19th November 2008 04:37 PM GMT]
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It's a big day in the consumer media, abuzz with the news that doctors engineered a windpipe for a 30-year-old woman using her own stem cells, but at the offices of Tengion, a Pennsylvania biotech currently building bladders using patient cells, it's just business as usual.

This news "confirms what we know," said Gary Sender, chief financial officer at Tengion. "We know we are in an emerging field."

Still, Sender added that any good news from the field of regenerative medicine is "very positive for Tengion." And for patients. "You and I as just citizens should be thrilled that there are advances in this technology," he said. "We think the more progress that's made in this field, the better."

Just today (Nov 19), Tengion announced that it completed a second closing of its Series C financing, receiving $21 million in additional equity. The company also recently wrapped up its phase 2 trial, consisting of 10 children with spina bifida, and plans to start a phase 3 sometime next year. (The company is not yet disclosing any data from the phase 2 trial.)

The company is also moving forward with its plan to build bladders for patients with bladder cancer, a somewhat trickier procedure because of the risk that the patient's cancer cells could end up in the new organ. Sender said the company hopes to fill out an investigational new drug (IND) application early next year, and begin a clinical trial soon thereafter.

When I visited the company's main 2800 square-meter manufacturing facility last year, the labs were largely empty, but slowly filling with the state-of-the-art equipment needed to ramp up to a phase 3 trial. The facility is now set to go, Sender said. "We're ready to roll with the phase 3" trial.


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