Toronto, Ontario – July 25, 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 is pleased to announce that at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) of its lead compound, TLD-1433, at the ninety (90) day cystoscopy analysis, the Company has achieved the exploratory endpoint of efficacy in patients inflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”).
These three 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 exploratory efficacy endpoint is being reported at ninety (90) days, in the first 3 patients treated, in the first part of a Phase Ib clinical study (“Study“).
The 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 Study is being used to evaluate TLD-1433 for the: primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy.
The Company previously announced on May 26, 2017 that the primary and secondary objectives for the first three patients treated in the Study had successfully been achieved.
The exploratory outcome endpoint in the Study is Recurrence-Free Survival (“RFS”). RFS is 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.
The first three (3) patients have demonstrated no recurrence of NMIBC lesions at the ninety (90) day cystoscopy analysis. One patient has presented with some reddened areas of the bladder wall, which will be biopsied at a future surgical date. Further clinical analysis will be conducted on the patients according to the approved clinical protocol.
An additional six (6) patients for the second part of the Study, are currently being enrolled, to be treated at a Therapeutic Dose of the PDC (0.70 mg/cm2) for NMIBC, using its novel PDT technology.
Dr. Arkady Mandel, Chief Scientific Officer of the Company stated, “The achievement of the exploratory outcome measure of efficacy for the treatment of NMIBC at ninety (90) days, in the first three (3) patients treated, for the first part of the Study, by the Company is extremely encouraging. I look forward to following the clinical reports and complete patient data to further validate these results at the scheduled clinical analyses defined by the approved clinical protocol.”
Dr. Mandel continued, “Theralase’s PDT approach is demonstrating remarkable safety, tolerability and efficacy for the Bacillus Calmette-Guérin (“BCG’) refractory and highly recurrent papillary (Ta) transitional cell carcinoma NMIBC population. Since the PDT procedure has been well tolerated and patients are able to undergo a repeat of the procedure, if required, this PDT treatment offers considerable therapeutic advantages.”
Roger Dumoulin-White, President and CEO of Theralase stated that, “The Company is ecstatic that after decades of hard work the Company, in the first 3 patients treated, at the 90 day cystoscopy follow-up, at a MRSD (0.35 mg/cm2) of TLD-1433, that the primary endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and now exploratory endpoint of efficacy have been achieved. I wish to thank the entire Theralase board and employees, the clinical and scientific team and the Medical and Scientific Advisory Board, who have provided their knowledge, experience and worked tirelessly to make this day a reality.”
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