For updated information regarding recent studies please click here.
NEW STANDARDS AND IMPROVED DETECTION
(DEC 2007/JAN 2008)
The platform is unique for detecting up-regulation of an enzyme that is expressed in high concentration in tumour tissue. Our patent for substrate specificity is unique in this area of research. The new proprietary assay we have evolved has improved our detection level by 10 to 100-fold over the original assay method.
NEW CONTROL STUDIES
This advance allowed us to analyze our cancer patient data much more intensively and to set the stage for the control arm of the study which was conducted in April and released in June 2008. Ethics board approval and subject recruitment met regulatory guidelines. This advance indicated the potential for detection of cancer at an earlier stage of the disease.
EXPANDABLE PLATFORM AND FUTURE POTENTIAL
This diagnostic platform allows us to use the technology for various other indications that we have identified as additional opportunities for market expansion. We have identified additional potential substrates that will be investigated for their ability to provide even greater sensitivity and specificity for detection of cancer. The recent patent application for the animal model will be instrumental to the screening of these candidate molecules for further product development, and give us a unique advantage to the evolution of new products in the future.
Phase II b involved the establishment of confidence limits from healthy subjects compared to cancer patients. This determined the basis for the cut off value in declaration of a positive test. The result of the study and the report were submitted to Health Canada in October 2008. Health Canada granted BioMark a CTA to continue into Phase III.
Successful PK studies were conducted in January-April of 2009 in China and the results have been incorporated into Phase III clinical study protocols. Elements of the study will be discussed at the World Cancer Conference in Beijing, June 20-25, 2009.