logo-loader

Medexus begins commercial launch of tumor imaging powder Gleolan in Canada

Published: 11:58 25 Feb 2021 EST

Tumor graphic
Gleolan had previously only been distributed under the Health Canada Special Access Program

Medexus Pharmaceuticals Inc (TSXV:MDP) (OTCQX:MEDXF) (FRA:P731) has initiated the Canadian commercial launch of Gleolan, a powder-based optical imaging agent taken orally by patients to help surgeons identify brain and spinal cord tumors called gliomas. 

Gleolan is an imaging agent that makes high-grade gliomas fluoresce under blue light, helping neurosurgeons better visualize these gliomas for more complete removal, the company said. 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. 

The product had previously only been distributed under the Health Canada Special Access Program. There are currently no other optical imaging agents approved in Canada for the purpose of visualization of malignant tissue during glioma surgery, the company said.

READ: Stifel GMP boosts target price of Medexus by 130%, saying Treosulfan could double company valuation

“Shipping the first Gleolan units to Canada last week was truly an important milestone, not only for us at photonamic and for Medexus, but most importantly for patients and neurosurgeons in the country,” Ulrich Kosciessa, CEO of Medexus’ licensing partner Photonamic said. “Many neurosurgeons have already been trained on the product by Medexus so that they can immediately start using it. Gleolan has already been used in over 100,000 cases worldwide, providing hope for patients with these certain types of brain tumours.”

A pivotal Phase III study published in The Lancet Oncology Medical Journal showed that using Gliolan during brain tumour surgery nearly doubled the rate of achieving a complete tumor resection (65% vs. 36%). This, in turn, resulted in double the number of patients who did not see brain tumor progression six months after surgery (41% vs. 21%).

“According to the Brain Tumour Registry of Canada, the incidence of glioblastoma is 4 per 100,000 people in Canada and about 1,000 Canadians will be diagnosed with glioblastoma every year,” Medexus VP of Specialty markets Kerry Bakewell said. “For this reason, we are extremely pleased to be able to expand the accessibility of Gleolan in Canada beyond the Health Canada Special Access Program. This allows us to provide Gleolan to more institutions and neurosurgeons, many of which have already been trained, and therefore they are educated on the product and immediate use is possible.”

John Sinclair, a neurosurgeon and Director of Neurosurgical Oncology at The Ottawa Hospital has seen Gleolan work first hand.

“When I first read European journal articles outlining the use of 5-ALA / Gleolan, I felt strongly that this represented an innovative surgical technique that would benefit our patients diagnosed with malignant gliomas,” Sinclair said. “With the support of Medexus, we have been able to bring Gleolan to Canada and help to develop its use across the country. To date, I have used this technique for approximately 75 patients and have directly observed its outstanding benefits during surgery which allow for enhanced optimal safe tumour resection. This research demonstrated that surgery done with 5-ALA led to an extended length of time to tumour recurrence and improved patient outcomes in comparison to traditional ‘white light’ surgery.”

Health Canada had previously granted Medexus authorization to distribute Gleolan in Canada under the Special Access Program, which provides healthcare practitioners with access to non-marketed drugs to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or unavailable, the company said. 

Then in March 2020, the Quality business unit at Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommended publicly funding Gleolan, which was conditional on Health Canada approval. Medexus is awaiting final funding approval from the Ontario Ministry of Health, the company said.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

Medexus Pharmaceuticals reveals record quarterly revenue of C$31.5M

Medexus Pharmaceuticals Inc (CVE:MDP) (OTCQX:MEDXF) CEO Ken d’Entremont tells Proactive its fiscal third quarter results revealed record quarterly revenue of C$31.5M, nearly doubling its revenue year-over-year from C$16.2M in the same period in 2019. d’Entremont added given significant share...

on 03/02/2021