Cancer has been characterized not as a single disease but as a collection of diseases. The complexity of cancer was highlighted again by the decoding of the human genome. Optimists anticipated that we would identify a handful of cancer genes and that new targeted drugs would cure cancer by regulating these mis-expressed genes. However, what we have discovered is that cancer is related to the inappropriate expression of hundreds of genes—not just one. Thus, even the newest targeted therapies, while making a contribution, are not doing much to significantly change mortality rates for many tumor types and the failure rate of oncology drug candidates entering clinical trials is about 95%.
Modern discoveries have also determined that carcinogenesis is not just a function of cell features, but also of the cell’s interaction with its microenvironment (stroma) and the immune response system.
Omnitura's Multifunctional Multitargeted (MFMT™) approach to cancer therapy is based on a systems biology strategy to address this fundamentally complex and heterogeneous nature of cancer by possessing multiple therapeutic functions and acting on multiple biological targets associated with carcinogenesis. MFMT therapies are also formulated to deliver multiple synergistic actives in small doses to avoid disruption of homeostasis and development of drug resistance.
Omnitura's lead MFMT cancer therapy, Aneustat™ (OMN54), has demonstrated in pre-clinical testing the potential to realize many of these goals.
Aneustat MFMT Therapeutic Activity Profile (patent pending)
Aneustat (OMN54)
- MFMT formulation for treating solid tumor cancers
- Orally delivered (260mg softgel capsule with 100mg active)
- Compelling pre-clinical data
- Efficacy against multiple tumor types
- Synergy with chemotherapy and radiation therapy
- Broad therapeutic window and no expected dose-limiting toxicity
- Potential for broad use including surgery adjuvant and maintenance for survivors
- Regulatory approval received for Phase I clinical trial
Aneustat™ (OMN54), the Company's lead therapy for lung and prostate cancer, is poised for human trials in 2008. Pre-clinical studies conducted at the British Columbia Cancer Agency have demonstrated significant efficacy (lung and prostate cancer inhibition) comparable with combination chemotherapy but with no visible side effects. Aneustat has been found to induce apoptosis and down regulate targets associated with angiogenesis. Additionally, cell cycle analysis of human tumors treated with Aneustat indicates that Aneustat sensitizes cancer tumors by arresting cells in certain stages of the cell cycle, making cancer cells more responsive to chemo and radiation therapy. Aneustat has also demonstrated synergy with a number of chemotherapeutic agents that will be further explored in clinical trials.
Based on the promise of Aneustat, Omnitura has formed an advisory panel of leading oncologists from Dana Farber, Johns Hopkins, MD Anderson, Nevada Cancer Institute, University of Miami, and University of Pittsburgh.