Toronto, Ontario – August 1, 2017
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotech 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 the fourth patient was treated, utilizing the Therapeutic Dose (0.70 mg/cm2) on July 20, 2017 for Non-Muscle Invasive Bladder (“NMIBC”) cancer using its novel Photo Dynamic Therapy (“PDT”) technology.
These patients come from a population that has failed standard of care and have remained drug resistant after the standard first line Bacillus Calmette Guérin (“BCG”) course of treatments.
The Phase Ib NMIBC clinical study (“Study”) is entitled “A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients with Non-Muscle Invasive Bladder Cancer at High Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guérin (“BCG”) and Who are Medically Unfit for or Refuse a Cystectomy”.
The PDT treatment procedure involves the instillation of a water based solution of Theralase’s lead anti-cancer PDC, TLD-1433, through the urethra into the bladder of the patient, to allow localization of the PDC to the NMIBC. The bladder is then drained of the solution, flushed with sterile water to remove excess solution and refilled with sterile water via a cystoscope. At this point, a fibre optic assembly, with the ability to both emit and detect laser light, is inserted through the cystoscope, to activate the PDC.
The Study is being used to evaluate TLD-1433 for the primary endpoints of safety and tolerability, a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.
The Study has demonstrated success in the treatment of the first 3 patients at the Maximum Recommended Starting Dose (“MRSD”) of the PDC (0.35 mg/cm2) and achieved the primary, secondary and exploratory endpoints at the 90 day cystoscopy analysis timepoint.
The exploratory outcome endpoint in the Study is Recurrence-Free Survival (“RFS”), defined as the interval from Day 0 (Day of treatment with TLD-1433 Photo Dynamic Therapy (“PDT”)) to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth (i.e. any biopsy-confirmed new or recurrent tumour), evaluated at ninety (90) days for the first three (3) patients treated at the MRSD (0.35 mg/cm2) and primarily at ninety (90) days for the next six (6) patients treated at the Therapeutic Dose (0.70 mg/cm2) and secondarily at one hundred and eighty (180) days post treatment.
Patient number 4 represents the first of an additional 6 patients to be enrolled and treated in the Study at the Therapeutic Dose of the PDC and evaluated according to the approved clinical protocol.
Roger Dumoulin-White, President and CEO of Theralase stated that, “The Company is pleased that it has successfully executed on the first part of the Study and has now advanced to the second part of the Study; specifically, the enrollment and treatment of an additional 6 patients at the Therapeutic Dose of the PDC. Theralase looks forward to successfully executing on the second part of the Study and will report out on its progress, as appropriate.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Corporation”) (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