Bioniche Life Sciences Inc., a research-based, technology-driven Canadian biopharmaceutical company, presented data from three studies using the company's proprietary Mycobacterial Cell Wall-DNA Complex (MCC) at the 2005 European Association of Urology 20th Congress in Istanbul, Turkey. MCC, trademarked Urocidin, is currently under development as a treatment for bladder cancer.

The presentations were made on Mycobacterial Cell Wall-DNA Complex (MCC) Interacts Rapidly with Bladder Cancer Cells and Demonstrates Synergy with Gemcitabine; The Direct Anticancer Activity of Mycobacterial Cell Wall-DNA Complex (MCC) is not Inhibited by Anti-MCC Antibodies and Intravesical Treatment with Mycobacterial Cell Wall-DNA Complex (MCC) Induces a Cytokine Profile Distinct from BCG.

The data, presented by Dr Nigel C. Phillips, chief scientific officer at Bioniche Life Sciences Inc., show: a) that MCC interacts rapidly with bladder cancer cells in vitro (interaction evident after two minutes and maximal interaction after 3 to 4 hours incubation) and shows strong synergistic interaction with Gemcitabine, a chemotherapeutic drug; b) that the direct anticancer activity of MCC is not inhibited by the presence of urinary anti-MCC antibodies generated in patients with bladder cancer who have been treated with MCC; and c) that MCC has a unique immune stimulatory profile as determined by measurement of urinary cytokines in patients with bladder cancer who have been treated with MCC.

"These data confirm that MCC has a unique mechanism of action, in that it can directly kill cancer cells (chemotherapeutic action) and in parallel participate in the stimulation of the immune system (immunotherapeutic)," said Dr Phillips. "This latter activity is important, as the immune system is often suppressed during the development of cancer and by the use of classical chemotherapeutic drugs or radiotherapy." Dr Phillips stated that the observation that MCC interacts rapidly with human bladder cancer cells is important for the treatment of bladder cancer, where treatment times of 1 to 3 hours are routinely encountered due to the limitations of intravesical administration.

He added that the data from patients who have been treated for bladder cancer with MCC in Phase II clinical studies demonstrates that immunological reactions against MCC (or pre-existing immune reactions against other mycobacterial immunotherapeutics such as BCG) are unlikely to influence the direct anticancer activity of MCC, and that data on the urinary cytokine profile elicited by MCC treatment confirms the distinct immune stimulatory mechanism of MCC. This latter observation is important, as the immune system is often compromised by age, during the development of cancer, and by the use of classical chemotherapeutic agents or radiotherapy.

Graeme McRae, president & CEO of Bioniche Life Sciences Inc., added that these non-clinical and translational studies continue to support MCC's unique dual mechanism of action (direct chemotherapeutic activity against bladder cancer cells and immune stimulant activity). He added that these data contribute to the company's high level of confidence as it moves into planned Phase III clinical studies in North America and Europe.