An early registration in Canada would generate revenues from commercial sales to offset the cost of additional clinical trial work that may be required for the U.S. and other jurisdictions.
The Company is also actively in discussions with potential new development/partners who are interested in obtaining rights to Urocidin™ in certain jurisdictions. Such partnerships are expected to generate up-front payments, milestones, development support, and licensing revenues.
The Company recently announced the establishment of a new wholly-owned private Human Health subsidiary - Bioniche Therapeutics Corp. The subsidiary is a standalone unit, and the new structure will allow direct external investment to support research and development activities, commercialization activities and acquisition opportunities, which may result in accretive value to the parent company. A search is ongoing for a Chief Executive Officer for the new subsidiary.
About Urocidin TMUrocidin™ is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin TM is formulated for the treatment of bladder cancer, where it 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. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales. About the First Phase III Clinical Trial with Urocidin™ The Company's first Phase III trial was a 129-patient open label, single-arm trial, meaning there was no comparator therapy used in the trial. The trial was designed to assess the safety and efficacy of Urocidin TM as a treatment of non-muscle-invasive bladder cancer in patients whose cancer had not responded positively to prior treatment with BCG therapy. This trial enrolled its first patient in November, 2006 and the last patient was enrolled in April, 2009. The last patient's last dose was administered in April, 2011 and the last patient's last visit occurred in December, 2011. Preliminary results, reported at urology association meetings in March, May and June, 2011, showed that, after 12 months, there was a 25% overall disease-free survival rate and the product was well-tolerated by patients with most adverse events considered "mild to moderate".