Bioniche said the study was not being recruited at the expected rate, and after recent discussions with the US FDA regarding the trial design, Endo has decided to end the study prior to completion. Shares of Bioniche Life Sciences (TSX:BNC) plummeted Monday after the biopharmaceutical company said that it is discontinuing a second phase III trial with Urocidin – a potential treatment for a type of bladder cancer.
The randomized, open-label, multi-centre study was being run by the company’s global licensing partner – Endo Pharmaceuticals – a subsidiary of Endo Health Solutions.
Bioniche said the study was not being recruited at the expected rate, and after recent discussions with the US FDA regarding the trial design, Endo has decided to end the study prior to completion.
The trial was designed to compare Urocidin with mitomycin, in the intravesical treatment of patients with recurrent or refractory non-muscle-invasive bladder cancer.
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“We are disappointed with this outcome, but we believe it is the best decision given the circumstances,” said president and CEO of Bioniche, Graeme McRae.
“We are working with Endo to determine the next steps for the Urocidin clinical program in order to build on the successful outcome of the first Phase III trial and to continue to work toward regulatory approval for this important and much-needed therapy.”
Bladder cancer is one of the leading causes of death among men and women and an estimated 357,000 bladder cancer cases occur worldwide each year.
Urocidin is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells.
Shares in Bioniche were lately down more than 15 per cent to 40 cents Monday afternoon.
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