Vancouver, British Columbia – (June 29th, 2021) – BioMark Diagnostics Inc. (“BioMark”) (CSE: BUX) (FSE: 20B) (OTCMKTS: BMKDF) is pleased to announce that Health Canada has approved its clinical trial application (CTA) and has granted a Letter of No Objection (NOL) for its application entitled Excretion of Acetylamantadine (AA) by Lung Cancer Patients During a Chemotherapy Regimen With or Without Immunotherapy. Since immunotherapy is now standard of care for lung cancer, BioMark amended the protocol to include study participants receiving immunotherapy and added the Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) as an additional site under the supervision of Dr Philippe Joubert. The amended protocol is intended to test the hypothesis that downregulation of SSAT1 activity as reflected by a reduced plasma concentration of acetylamantadine, will occur earlier than can be detected by other diagnostic testing methods used to determine the efficacy of chemotherapy combined or not to immunotherapy in patients with a diagnosis of stage III lung cancer. This amendment approval from Health Canada will facilitate the study and permit achieving the required sample size in a timely manner. Patient recruitment is anticipated to commence later in the 3rd quarter.
“The assessment of tumor response to therapy is of critical importance as it permits for a prospective end point evaluation and provides a guide to clinicians for making future treatment decisions. We are excited to expand our liquid biopsy platform using SSAT assay for this important clinical indication. This could be used as a simple and effective test to assess response to treatment and to better tailor treatment of the patient as well as reducing side-effects and costs.”, says CEO Rashid Bux.
This study on lung cancer patients is a follow-up to a previous study performed to determine the urinary levels of AA in normal healthy volunteers and in patients with a cancer diagnosis. The company would like to thank all investigators involved in this work, Drs. Andrew Maksymiuk, (CancerCare Manitoba), Daniel S. Sitar (College of Medicine, Faculty of Health Sciences, University of Manitoba), Bram Ramjiawan and Paramjit Tappia, (Asper Clinical Research Institute), Philippe Joubert (IUCPQ – Department of Pathology, Laval University), as well as David Wishart (The Metabolomics Innovation Centre) for their excellent effort in developing and modifying the protocol, submitting all the material to Health Canada and eventually securing the NOL.
Advanced Stage Lung Cancer
For advanced-stage lung cancer, systemic chemotherapy and immunotherapy are the main choices for therapy. The objectives are usually palliative in intent: i.e., to maintain or improve symptoms and quality of life, with the additional benefit of improving the survival duration – though falling short of cure in most cases. Evaluation of response is often challenging as it may require several months to assess regression using conventional techniques of physical examination, radiographic studies and/or conventional laboratory biochemistry studies. Therefore, many patients may endure side-effects of therapy for several months before clinicians are able to determine if therapy will be effective in achieving the intended therapeutic outcomes. BioMark’s assay is intended to monitor response faster and more accurately.
About BioMark Diagnostics Inc.
BioMark is developing proprietary, non-invasive, and accurate cancer diagnostic solutions which can help detect, monitor and assess treatment early for hard to detect and treat cancers. The technology can also be used for measuring response to treatment and potentially for serial monitoring for cancer survivors.
For further information on BioMark, please Contact:
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Email: [email protected]
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