Bioniche partner pulls plug on Urocidin trial

By Dylan Bushell-Embling
Tuesday, 06 November, 2012

Bioniche (ASX:BNC) global licensing partner Endo Pharmaceuticals has discontinued a phase III trial of the company's Urocidin in non-muscle-invasive bladder cancer.

The US trial, which forms part of a regulatory application for the product, has been called off prematurely.

Announcing the move, the companies said the study had not been recruiting at the expected rate, and Endo decided to end the study “after recent discussions with the US FDA regarding the current clinical trial design.”

Under the terms of the Urocidin licensing agreement, Endo had agreed to pay for the external costs of clinical activities.

“We are disappointed with this outcome, but we believe it is the best decision given the circumstances,” Bioniche CEO Graeme McRae said in a statement.

A spokesperson for Bioniche referred inquiries about the cancellation to Endo Pharmaceuticals, but said the companies are working together to explore options for moving forward. Endo could not be contacted in time for publication.

Urocidin is a formulation of sterile mycobacterial cell wall-DNA complex composition MCC, delivered directly to the bladder via trans-urethral catheter. It is designed to stimulate the immune system as well as have a direct anticancer response.

Bioniche's animal health business - which its Australian operations are focused on – has developed and launched a cancer treatment for dogs using the same underlying technology, with a second product on the way.

Bioniche (ASX:BNC) shares last traded at $0.450.

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