May 9, 2012
Bioniche Life Sciences Inc. Reports Q3, Fiscal 2012 Results

May 1, 2012
Bioniche Life Sciences Inc. Commercializing Two Products for Canine Cancer

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Our research and development program is based on the following 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 trial was initiated in November, 2006, for patients with non muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard therapy – BCG. The Urocidin^TM clinical program is now being funded by and led by Endo Pharmaceuticals Inc. in partnership with Bioniche Life Sciences Inc

Refractory trial

For more information about the Company’s clinical programs, 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.

Escherichia coli O157 Bacterial Extract Vaccine

Enterohaemorrhagic Escherichia coli O157:H7 (EHEC) is an important pathogen of humans, causing severe diarrhea and haemolytic uremic syndrome (HUS). In North America, EHEC serotype O157:H7 is most prevalent, causing 85-95% of HUS cases. Cattle are an important reservoir of E. coli O157:H7 and as such, are a major source of infection in humans, through direct contact or the consumption of contaminated meat, water, or produce. E. coli O157:H7 infection of cattle requires type III secreted proteins (TTSP) which enable the bacteria to colonize the intestinal mucosa. Bioniche Animal Health has developed an E. coli O157:H7 TTSP vaccine that contains the TTSP proteins EspA, EspB and Tir. The efficacy of this vaccine has been evaluated in cattle using natural exposure and controlled challenge studies.

To assess the effects of vaccination on the shedding of E. coli O157:H7, calves were vaccinated with three doses and challenged with E. coli O157:H7 14 days later. There was a 2.28 log10 reduction in the magnitude of shedding in vaccinated animals compared to controls. In another study, with a three dose vaccination and natural exposure to E. coli O157:H7, vaccinated animals were less likely to be colonized by the bacteria in the mucosa of the terminal rectum at harvest (OR=0.014, p<0.0001), resulting in a vaccine colonization efficacy of 98.3%. A two dose vaccination was used to evaluate hide contamination in the feedlot. Hides were sampled for E. coli O157:H7 contamination twice in the feedlot and immediately before and after animals were shipped to the abattoir. Vaccinated animals were less likely to have contaminated hides, with a vaccine efficacy of 53.8%. Additionally, pen-level prevalence following a two dose vaccination was assessed in a feedlot study. Vaccinated pens were less likely than unvaccinated pens to test positive (OR=0.59, p<0.004) using the ROPES method.

These results indicate that vaccination of cattle with the Bioniche E. coli O157 vaccine has the potential to be an effective pre-slaughter intervention method for the reduction of E. coli O157:H7 shedding, colonization, hide contamination, and pen-level prevalence.

Rogan D.R., Smith D.R., Moxley R.A., Potter, A.A., Yome J.L., July, 2008