BioMark Diagnostics Inc
Wednesday, November 01, 2017 - 9:00 AM EDT

BioMark’s Clinical Trial and Research Update



Vancouver, British Columbia (FSCwire) - 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.

 

About BioMark Diagnostics Inc.

 

BioMark is developing proprietary, non-invasive, and accurate cancer diagnostic solutions, which can help, detect, monitor and assess treatment for cancer early and cost effectively. The technology can also be used for measuring response to treatment and potentially for serial monitoring for cancer survivors.

 

Further information about BioMark is available under its profile on the SEDAR website www.sedar.com and on the CSE website www.thecse.ca.

 

For further information on BioMark, please Contact:

 

Rashid Ahmed Bux

President & CEO

BioMark Diagnostics Inc.

Tel. 604-282-6567

Email: info@biomarkdiagnostics.com 



To view this press release as a PDF file, click onto the following link:
public://news_release_pdf/Biomark11012017.pdf

Source: BioMark Diagnostics Inc (CSE:BUX, OTCQB:BMKDF, FWB:20B)

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