Vancouver, British Columbia – (November 1, 2017) – BioMark Diagnostics Inc. (“BioMark”) (CSE: BUX,
FSE: 20B, OTCMKTS: BMKDF) is pleased to provide the latest clinical trial update. The company
analyzed samples from the clinical trials samples at a Good Laboratory Practice (GLP) facility, which
utilized the Company’s internal standards (obtained under Health Canada’s Investigational Testing
Authorization application # 229838).
Listed below are the accomplishments thus far:
1. Clinical trial is still ongoing at Saint Boniface Research Centre (SBRC). Preliminary
analysis of data has been conducted for the 218 patient trial that was granted by Health
Canada under CTA# 156730. Majority of the diseased patients’ recruits for this study
were lung cancer patients.
2. The Canadian Principal Investigators (PIs) have reviewed the data with a biostatistician
and medical team from Bangladesh. The results are directionally very encouraging, and
both the groups have recommended further information/investigation on the control
population with specific inclusion / exclusion criteria due to a number of very high
outliers defined as subjects who were considered Healthy but exhibited high Acetyl
Amantadine concentrations. There is a need now for this control group cohort to be
followed to determine that they in fact could be cancer patients who have not
exhibited symptoms. Additional investigation on the control group has commenced
following a new ethics approval from health authorities in Bangladesh. We estimate that
it should last about 2 months for a first review of their condition. It is important to
demonstrate that there is a significant difference in assessment of persons who are
healthy versus cancer patients, and this cannot be done unless the outliers in the
control group are well characterized. A new control group consisting of 35 patients has
been recruited and samples collected from Bangladesh. This new group was selected
based on a modified inclusion/exclusion criteria and new data from this group will
further determine the impact of confounders that will be important when we introduce
the tests for clinical application.
3. Based on BioMark’s previous control studies in Canada, several subjects who were
considered Healthy exhibited high Acetyl Amantadine concentrations. The follow up of
these subjects required Ethics and Health Canada Approval i.e. for permission from
these participants to delve further into their conditions. The follow up studies have now
received St. Boniface research review committee approval. The necessary systematic
follow up on those persons with the principal investigator has now begun. This
information may be important for the development of the submission package to be
filed with Health Canada, and could demonstrate better accuracy and robustness in use
of our assay for predicting cancer prior to manifestation of symptoms of the disease
(again similar to point 2 above).
4. Clinical trial on measuring response to chemotherapeutic treatment will begin at
CancerCare Manitoba under the direction of Dr. Andrew Maksymiuk
Next Steps
As soon as all the data are received and tabulated, a comprehensive submission package
will commence. Our target date for submission is within 2-3 months after the
completion of the new incoming data analysis or earlier.
