Our research and development program is based on the following proprietary technology platform:
Mycobacterial Cell Wall-Nucleic Acid Complex (MCNA) is a cell wall-nucleic acid composition prepared from a pure culture of the bacterium Mycobacterium phlei. The cell wall complex has been fractionated and purified to optimize the presence of the nucleic acid, which is responsible for the range of immunomodulatory and direct anti-cancer activities.
Bioniche has focused its preclinical and clinical research on the use of its MCNA technology in the treatment of cancer. These research programs have demonstrated MCNA's effectiveness as an immunomodulator and anti-tumour agent in a range of models. The company has achieved a research breakthrough by identifying mycobacterial nucleic acidas the active component of Mycobacterium phlei cell wall preparations.
MCNA has a dual mode of action in that it induces apoptosis in cancer cells as well as stimulates anti-cancer cytokine production by immune effector cells.
The mycobacterial nucleic acid in MCNA induces apoptosis (programmed cell death) in cancer cells. The induction of apoptosis occurs in cancer cells including multi-drug resistant cancer cells and in cells with mutations in cell cycle regulators. The induction of apoptosis is associated with a dose-dependent inhibition of cancer cell division, and this activity has been demonstrated in a wide range of cancer cells including bladder, breast, leukemia, melanoma, ovarian and prostate.
MCNA induces macrophages to produce cytokines including IL-6 and IL-12. IL-12 is known to possess anti-angiogenic activity (prevention of blood vessel formation in tumours) and activates NK (natural killer) and cytotoxic T lymphocytes that are associated with anti-cancer responses. Bioniche believes that MCNA's ability to induce apoptosis in cancer cell lines regardless of the presence of mutations in tumour suppressor genes and multi-drug resistance is significant. Accumulated mutations in cancer cells can often lead to significantly greater resistance to treatment, eventually making conventional chemotherapeutic strategies ineffective.
Urocidin™ - a suspension of MCNA - is currently being tested in a Phase III clinical program in bladder cancer. The first trial was conducted by Bioniche involving 129 patients with non-muscle-invasive bladder cancer that was refractory (unresponsive) to the current standard therapy – BCG. This trial was an open label, single-arm trial, meaning there was no comparator therapy used in the trial. This design was ethical and permitted by regulators and ethics committees due to the fact that no approved therapy was available for patients with non-muscle-invasive bladder cancer who failed prior BCG therapy.
The Company identified a goal of achieving a clinically meaningful complete response rate with a safety measure of less than 10% of patients unable to tolerate treatment. This trial enrolled its first patient in November, 2006 and the last patient was enrolled in April, 2009. The preliminary results were reported at urology association meetings in March, May and June, 2011.
In terms of efficacy, the trial resulted in a 12-month 25% disease-free survival outcome. The therapy was well-tolerated, with most adverse events being mild to moderate.