Medexus Announces Expanded Availability of Gleolan in Canada

TORONTO and CHICAGO and MONTREAL, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) announced today that it has initiated the commercial launch of Gleolan in Canada, which had previously only been distributed under the Health Canada Special Access Program. Gleolan is a 5-aminolevulinic acid hydrochloride (5-ALA) powder for oral solution, and is indicated as an adjunct for the visualization of malignant tissue during surgery in patients with Grades III or IV gliomas (suspected on preoperative imaging) as classified by the World Health Organization (WHO).   

"Every day in Canada it is estimated that 27 new primary brain tumours will be diagnosed.  With limited treatment options, and expanded availability of Gleolan in Canada, which assists neurosurgeons in successfully removing brain tumours, brings hope to patients facing this often devastating disease,” stated Susan Marshall, CEO for Brain Tumour Foundation of Canada, which supports the 55,000 people in Canada affected by brain tumours.  

Gleolan is an imaging agent that makes high-grade gliomas (malignant, rapidly progressive brain tumours) fluoresce under blue light, assisting neurosurgeons to better visualize these gliomas for more complete removal. After administration, areas within the tumour glow pink or red, and healthy brain tissue appears blue when exposed to a special blue light during surgery.  There are currently no other optical imaging agents approved in Canada for the purpose of visualization of malignant tissue during glioma surgery.

A pivotal Phase III study, published in The Lancet Oncology Medical Journal, has shown that use of Gliolan during brain tumour surgery has nearly doubled the rate of achieving a complete resection of the tumour, which in turn has resulted in a doubling of the number of patients without progression of their brain cancer six months after surgery.^[1]  The study reported complete resection of malignant brain tumor tissue in 65% of patients receiving Gliolan compared to 36% of patients in the study's control arm (difference between groups 29% [95% CI 17-40], p<0·0001). Six-month progression-free survival was achieved in 41% of patients receiving Gliolan compared to 21% of patients who were operated on without the use of the drug (difference between groups 20% [95% CI 9·1–30·7], p=0·0003).^[1]