Theralase Technologies (CVE:TLT) (OTCMKTS:TLTFF), a biotechnology manufacturer, said Health Canada has approved its next generation anti-cancer drug, TLD-1433, under clinical trial application (CTA) for evaluation in a Phase Ib clinical trial for patients with non-muscle invasive bladder cancer (NMIBC).
Health Canada recently reviewed the CTA submitted by Theralase Technologies, the Toronto, Ontario-based company said in a statement on Thursday.
Health Canada has issued a “No Objection Letter” stating that Health Canada has no objection to the proposed Phase Ib clinical study, a standard response.
This allows Theralase to proceed with enrolling patients who meet the inclusion and exclusion criteria of the study pending Health Canada Investigational Testing Authorization (ITA) of the TLC-3200 medical laser system used to activate TLD-1433 in the bladder and University Health Network Review Ethics Board (UHN REB) approval of the clinical protocol.
“The company has focused its resources on the successful completion of four major strategic objectives prior to yearend," CEO Roger Dumoulin-White said in the statement.
Theralase said it has now completed the first 2.5 of these four strategic objectives and is working hard to complete the remaining objectives prior to yearend.
"We are all extremely proud of this accomplishment and look forward to proving the main study objectives of safety and tolerability of our next generation anti-cancer technology, but also the exploratory objective of efficacy in a patient population inflicted with this deadly disease,” he added.
The shares closed up 2.9% at C$0.355 on Wednesday, trimming this year's retreat to 38%.
Theralase is a company that is focused on commercializing medical technologies to eliminate pain and destroy cancer.