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BIOMARK TEAM SECURES HEALTH CANADA LETTER OF NO OBJECTION FOR ITS GLIOBLASTOMA CLINICAL TRIAL

August 27, 2020

Vancouver, British Columbia – (August 27th, 2020) – 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 ACETYL-AMANTADINE AS A BIOMARKER IN PATIENTS WITH GLIOBLASTOMA.

 

The company would like to thank Dr. Marshall Pitz the principal investigator and is the Section Head of Clinical Research at the Research Institute at CancerCare Manitoba (CCMB) and other co- PIs that include Dr. Donald Miller, Dr. Thomas Klonisch, Dr. Marco Essig, Dr. David Wishart, Dr. Ted Lakowsky and Dr. Anmol Mann for their excellent effort in developing the protocol, submitting it to ethics review board (ERB) and eventually securing the NOL so that BioMark team can commence the trials by October. “Assembling a high impact multi- disciplinary team to collaborate in developing this potentially disruptive diagnostic test that can improve identification and care for patients with glioblastoma is exciting and critically required to positively impact treatment care for patients suffering with Glioblastoma”, says CEO Rashid Bux.

 

About Glioblastoma Multiforme (GBM)

The most common primary brain tumour in adults is glioblastoma (GBM). Originating from transformed neural precursor cells, GBM is a highly aggressive and infiltrative brain tumour.  The death rate of GBM worldwide is approximately 225,000 per year (1).  While GBM has a lower incidence than many other cancers, the prognosis is particularly poor with average survival from time of diagnosis being approximately 14-16 months (2, 3).  Furthermore, compared to other cancers such as breast cancer, which have seen significant advancements in treatment and increased survival, the survival rates for GBM remain similar to those 30 years ago (4).

Monitoring of tumour response is typically through magnetic resonance imaging (MRI) of the brain, conducted every 2-3 months. The poor prognosis associated with GBM is a combination of lack of early detection, incomplete surgical resections of tumour mass and ineffective postsurgical treatment options.  Thus, the ability to detect GBM while the patient is still asymptomatic is likely to create a positive ripple effect with improvements in both the surgical resection and radiation and chemotherapeutic outcomes.  Perhaps an even more profound impact of the proposed study is the potential use as a diagnostic drug biomarker to monitor GBM progression during treatment and early detection of tumour re-occurrence. Thus, a reliable and affordable diagnostic agent that could monitor therapeutic response in GBM patients would allow the clinician and patient to move to new therapies more quickly. The glioblastoma (GBM) market is expected to grow from $662.0m in 2017 to $1.4bn in 2027 across the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 7.5%, according to GlobalData.

References:

  1. Alphandery E. (2018). Glioblastoma treatments: An account of recent industrial developments. Front. Pharmacol. 9:879.
  2. Thakkar JP, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, and Villano JL. (2014). Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol. Biomarkers Prev. 23:1985-1996.
  3. Carlsson SK, Brothers SP, and Wahlestedt C. (2014). Emerging treatment strategies for glioblastoma multiforme. EMBO Mol. Med. 6:1359-1370.
  4. Fine HA. (2015). New strategies in glioblastoma: exploiting the new biology. Clin Cancer Res. 21:1984-1988.

Press Release – BIOMARK TEAM SECURES HEALTH CANADA LETTER OF NO OBJECTION FOR ITS GLIOBLASTOMA CLINICAL TRIAL