BioMark’s Top Accomplishments
The BioMark team continues to reduce risks associated with the project by ensuring the science and regulatory management drive the allocation of resources.
• BioMark commenced phase III trials at Saint Boniface Research Centre in October 2013 and is now expanding to additional 2 sites – China and Bangladesh for 2014
• First generation Acetyl Amantadine Elisa Kits have been developed (Jan 2014) and necessary validation and selected tests are being conducted to meet technical and regulatory standards.
• Blinded tests with established industry gold standards are planned for later in 2014
• Additional studies are underway to establish Proof of Concept on BioMark’s leading antibody based drug. Further IND planning activities are being planned post proof of concept completion
• Started a Control Group III re-trial based on PK data from China. A new CTA from Health Canada and Ethics Board approval was obtained in October 2011 and the trial commenced in late November 2011 and completed late April 2012 at Saint Boniface in Manitoba. Reconfirmed prior PK tests in China. BioMark has obtained approval for phase III clinical trial from Health Canada and will be commencing the studies in December of 2012 at Cancer Care Manitoba.
• BioMark has filed provisional patents for 2 novel antibody based therapeutic agents.
• BioMark has filed a provisional patent in December 2012 for a new approach in detection using Raman IR systems with the University of Victoria.
• BioMark has filed a provisional patent in December 2012 for the generation of small molecule antibody that will be used for development of IVD kits.
• BioMark has begun studies in December 2012 with Manitoba Tumour Bank for SSAT gene expression studies.
• New targeted imaging studies with the University of British Columbia, BC Pre-clinical Consortium and Triumph is underway with expected results early 2013.
• Successfully identified 3 additional substrates into our patent portfolio beyond amantadine. This would provide potential avenue for use of new substrates – conduct cell line and xenograft models for drug screening application.
• Established and generated our data on the presence of SSAT in 3 cancer cell lines based on a positive correlation of RT-qPCR of mRNA and functional SSAT activities to confirm the comparative non-specific as Northern-blot data.
• Completed Km and Vmax for new SSAT1 substrates.
• Better understanding of SSAT1 and SSAT2 for targeted application.
• Generated monoclonal antibody for acetyl amantadine but need to ensure no affinity for amantadine – patented in 2012.
• Funded by National Research Canada IRAP starting April 2010 through 2012.
• BioMark selected as top 4 Canadian company by Canadian Government to commercialize technology in Silicon Valley Genentech Centre in San Francisco, USA.
BioMark Technologies Summary
BioMark Summary (PDF) [Right click to download]