September 24, 2008
Canadian Regulator Recognizes Efficacy and Safety of Bioniche E. coli O157 Cattle Vaccine

September 19, 2008
Bioniche Reports Fiscal 2008 Year-End Results

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Our research and development program is based on three proprietary platform technologies:

MCC

Mycobacterial Cell Wall-DNA complex (MCC) is a cell wall-DNA 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 active molecule, DNA, 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 MCC technology in the treatment of cancer. These research programs have demonstrated MCC's effectiveness as an immunomodulator and anti-tumour agent in a range of models. The company has achieved a research breakthrough by identifying mycobacterial DNA as the active component of Mycobacterium phlei cell wall preparations.

MCC 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.

APOPTOSIS:
The mycobacterial DNA in MCC 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.

IMMUNOMODULATORY ACTIVITY:
MCC 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 MCC'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^TM – a formulation of MCC - is currently being tested in a Phase III clinical program in bladder cancer. The first of two trials was initiated in November, 2006, for patients with non muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard therapy – BCG.

Refractory trial

Comparative Trial

The second Phase III trial will enrol approximately 800 patients in North America, Australia and Europe and is a double-blind, randomized study. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression – Bacillus Calmette-Guérin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often associated with treatment-limiting side effects including active bacterial infections.

The primary efficacy endpoint will be the duration of disease-free survival of patients after two years. In addition, safety will be evaluated based on two criteria: the percentage of patients who experience two consecutive delays of one week in treatment administration due to drug-related adverse events; and through a comparative tabulation of drug-related adverse events. The goal will be to demonstrate non-inferior efficacy and improved safety of Urocidin over BCG.

For more information about the Company’s clinical program in bladder cancer, please contact Bioniche Therapeutics at clinicaltrials@bioniche.com.

Oligonucleotides

In 2000, Bioniche announced the discovery of a new class of molecules with potential anti-cancer activity, termed Oligomodulator™. This new class of molecules, with potential clinical anti-cancer activity and immune modulating properties, is composed of short DNA oligonucleotides that appear to possess a range of novel pharmacological activities.

The company's pre-clinical research indicates that the ability of these molecules to inhibit the division of human cancer cells occurs as a result of blocking the cell cycle and inducing programmed cell death (apoptosis). These oligonucleotides also have the ability to stimulate cytokine synthesis from certain mononuclear cells. Activity has been demonstrated against a range of different human cancer cell types, offering potential for their development as novel chemotherapeutic agents with wide-ranging applicability for the treatment of cancer.

This new technology platform has the ability to quickly synthesize and test new sequences and analogues and the potential to develop oligonucleotide combinations for specific appllications (the "toolbox" approach). This approach will allow Bioniche to tailor the pharmacological activity of the oligonucleotides to the disease (e.g., direct anti-cancer activity or immune stimulation/vaccine adjuvant activity).

Bioniche continues to advance this platform into the clinical phase of testing. Toxicity studies are underway in preparation for an Investigational New Drug (IND) application. The company's objective is to develop one or more oligonucleotide drug candidates and to be in a position to commence clinical evaluation in a Phase I study.

Hyaluronic Acid

Hyaluronic acid is a naturally occurring substance present in all human and animal connective tissues, and is found in high concentrations in the synovial fluid within the joints. Bioniche therapeutics has commercialized two proprietary products based on the hyaluronic acid platform technology—Cystistat®, used for the treatment of symptoms from multiple forms of cystitis, including interstitial cystitis, radiation-induced cystitis, and recurrent bacterial cystitis; and Suplasyn®, used in the treatment of osteoarthritis.