Toronto, Ontario – June 13, 2017
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotechnology company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that its latest research on dosimetry planning and Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study data (“Study”) was recently presented on June 9th, at the 16th International Photodynamic Association (“IPA”) World Congress held from June 8th to 13th, 2017 in Coimbra, Portugal.
The IPA was founded in 1986 and its membership consists of some of the most prominent international clinicians and scientists involved in performing and researching Photo Dynamic Therapy (“PDT”) and Photo Diagnosis (“PD”). The IPA promotes the study of diagnosis and clinical treatment using light and Photo Sensitizers (“PSs”), and disseminates this knowledge to IPA members, the medical community and the general public. The IPA World Congress is held every two years and is quickly becoming known as the premier forum to communicate outstanding advances in the clinical and research aspects of PDT and PD.
The clinical data for the initial three patients treated in the Study with the recommended starting dose of TLD-1433 PDC (0.35 mg/cm2), which laid the groundwork for an advanced , personalized and patient specific PDT platform technology was presented at the 16th IPA World Congress.
Theralase is using the Study to evaluate its lead PDC, TLD-1433, for the: primary endpoint of safety and tolerability, secondary endpoint of Pharmaco Kinetics (“PK”) (movement and exit of drug within tissue) and exploratory endpoint of efficacy.
A Theralase affiliated researcher presented, “Creating and monitoring a steep PDT-dose gradient for intravesical Non-Muscle Invasive Bladder Cancer.”
The Theralase patented PDC, TLD-1433 has demonstrated pre-clinically that it is:
- Highly soluble and stable in water (demonstrating versatility to be used intravesically (instilled through a catheter) into the bladder or intravenously into tissue)
- Exceptional ability to destroy in-vivo tumors across various animal models
- Proven safe in Good Laboratory Practice (“GLP”) pharmacology and toxicology studies
Photographic data demonstrating how TLD-1433 had the ability to localize specifically to human bladder cancer tumours during the Phase Ib NMIBC clinical study, staining them yellowish after a sixty minute intravesical installation, while leaving healthy bladder urothelium untouched.
The Target Light Radiant Exposure (“Dose”) of 90 J/cm2 (+/- 20%) was achieved in the first 3 patients based on 6 light dose sensors.
The clinical evidence of the primary outcome measure of safety and tolerability demonstrated that there were no Significant Adverse Effects (“SAEs”) observed in the patients during the 30 day follow-up period post treatment and the only Adverse Events (“AEs”) reported during that period were mild or moderate in nature, and hence not clinically significant, with over 80% of them (9/11) completely resolved within 21 days of treatment. These clinical findings on the first 3 patients supported the conclusion of achievement of the primary outcome measure of safety and tolerability of the PDT treatment.
The clinical evidence of the secondary outcome measure of PK demonstrated that the amount of TLD-1433 resident in plasma was less than 1 ng/ml after 24 hours and virtually negligible 72 hours post treatment. The amount of TLD-1433 resident in urine was less than 100 ng/ml after 24 hours and virtually negligible 72 hours post treatment.These clinical findings on the first 3 patients supported the conclusion of achievement of the secondary outcome measure of PK of the PDT treatment.
Note: Data points represent average TLD-1433 concentrations per ml of sample (mean +/- standard deviations). n = 3 patients.
The TLC-3200 Medical Laser System (“TLC-3200”) combines laser light delivery and dosimetry via the TLC-3400 Dosimetry Fibre Optic Cage (“TLC-3400” or “DFOC”) to deliver laser light energy of a specific wavelength (“nm”) and energy density (“J/cm2”) to the bladder wall. The TLC-3200 then visibly signals the surgeon via a computer monitor when this irradiation has been achieved and to discontinue treatment.
The DFOC thus allows the surgeon to adjust Dose delivery in direct response to: bladder shape, volume and diffuse reflectance of the bladder wall, thus providing a consistent Dose to the patient’s inner bladder wall surface.
The current approach taken by Theralase in personalizing the drug and light delivery during PDT treatment of NMIBC allowed the achievement of the primary endpoint of safety and tolerability, as well as the secondary endpoint of PK on the first three patients. This initial analysis allowed the determination of the preferable dose (light and PS) ultimately maximizing the success of subsequent phase II clinical trials.
Conclusions of the presentation included:
- TLD-1433 has good selectivity compared to other PSs
- Intravesical instillation is adequate to deliver TLD-1433 to NMIBC
- Laser light of 525 to 532 nm in wavelength provides effective activation of the PDC up to 2 to 3 mm, more than sufficient for NMIBC
- Irradiance across the bladder surface is heterogenous
- TLD-1433 NMIBC PDT produces non-clinically significant AEs.
- Longer term observations will determine the efficacy of the PDT treatment
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase is delighted that the latest dosimetry planning and Phase Ib clinical study results were presented to such a respected group of international researchers and clinicians at the 16th IPA World Congress. This research will ultimately allow Theralase to successfully commercialize this next generation PDT technology, after efficacy has been proven, now that safety, tolerability and PK have been established.”
Based on these clinical findings, the independent Data and Safety Monitoring Board (“DSMB”) has unanimously decided that the primary and secondary objectives for the first part of the Study have successfully been met and an additional 6 patients are now eligible to be enrolled into the Study to be treated at a therapeutic dose of the PDC (0.70 mg/cm2) and monitored for 180 days, according to the endpoint criteria.
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the treatment of chronic knee pain, and in off-label use, the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which localize to cancer cells and then when laser light activated, effectively destroy them.
Additional information is available at www.theralase.com and www.sedar.com .
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For More Information:
Roger Dumoulin-White
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225