NEWS 9-10-15TORONTO, ON / ACCESSWIRE / September 10, 2015 / Theralase Technologies Inc. ("Theralase" or the "Company") (TLTFF) (TSX Venture: TLT), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has successfully completed the toxicology analysis of its lead Photo Dynamic Compound ("PDC"), TLD-1433, in compliance with Good Laboratory Practice ("GLP") standards. This milestone is critical for a Clinical Trial Application ("CTA") submission to Health Canada.
Pending Health Canada approval of the CTA, Theralase would commence enrolling patients inflicted with Non-Muscle Invasive Bladder Cancer ("NMIBC") into a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy.
Completion of the GLP toxicology analysis of TLD-1433 has now achieved the second major milestone for the Company to complete its submission of a CTA application to Health Canada for NMIBC.
Key components required to submit a CTA to Health Canada for a new drug / device combination include:
1. GMP manufacture including CMC information for the drug (Complete);
2. Good Laboratory Practice ("GLP") Toxicology Analysis of the drug (Complete);
3. Completion of the Clinical Protocol and Investigator's Brochure;
4. Completion of detailed information regarding the device used in conjunction with the drug.
Conclusions of the GLP toxicology analysis demonstrate success in both the rat and dog models evaluated. The rat model successfully determined toxicity levels after an intravenous ("IV") injection, while the dog model successfully determined toxicity levels after an intravesical bladder installation followed by Photo Dynamic Therapy ("PDT") laser light activation.
In the rat toxicology study, the No Observed Adverse Events Level ("NOAEL") IV limit was determined to be 1.2 mg/mL (6 mg/kg).
In the dog toxicology study, NOAEL was determined to be 6 mg/ml (30 mg/kg) for dog bladder infusion. Within 24 hours after instillation, the maximum level of TLD-1433 detected in blood was 0.03 ug/mL. This value is 200,000 times less than the instilled dose, indicating an ultra-low level of seepage into the blood stream supporting an extremely high safety margin. 7 days after infusion, the maximum level of TLD-1433 detected in blood was 0.002 ug/mL. This value is 3 million times less than the instilled dose, indicating a barely detectable level of TLD-1433 in the blood stream. This supports the conclusion that an infusion of 6 mg/ml of TLD-1433 (high human dose) into the bladder will be almost completely removed from the blood stream within 7 days. Thus the patient may be light sensitive for up to 7 days, which is significantly less than 30 to 90 days for Photofrin (R).
In summary, the maximum detected dose in the blood stream within 24 hours after Beagle bladder infusion is 40,000 times lower than the IV NOAEL and 600,000 lower in 7 days, making bladder infusion an extremely safe route of administration for patients presenting with NMIBC.
Roger Dumoulin-White, President and CEO, Theralase stated that, "Theralase is executing on its strategic initiative to advance our anti-cancer technology to commence destroying NMIBC this year. Theralase has now completed the second major milestone of the CTA application and is well on its way to completing all the remaining steps of the CTA application in 3Q2015 in order to allow commencement of a Phase Ib clinical study in late 4Q2015."
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