HUGE NEWS-- TLTFF Theralase's patient No. 6 free of bladder cancer
2018-05-17 09:38 ET - News Release
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An anonymous director reports
THERALASE PROVIDES UPDATE ON PHASE IB NON-MUSCLE INVASIVE BLADDER CANCER CLINICAL STUDY
Theralase Technologies Inc. has provided an update on the phase 1b non-muscle invasive bladder cancer (NMIBC) clinical study currently in progress.
The study is being used to evaluate TLD-1433, Theralase's lead PDC, 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 exploratory outcome endpoint is recurrence-free survival (RFS), defined as the interval from day 0 to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth, evaluated at 90 days for the first three patients treated at the maximum recommended starting dose (MRSD) and primarily at 90 days for the last six patients treated at the therapeutic dose and secondarily 180 days post treatment.
As previously reported, the company, in conjunction with its clinical partner, have optimized the clinical procedure of the study commencing with patient number five, who was enrolled and treated in January 2018. The treatment was well tolerated by the patient, who demonstrated no tumour recurrence or presence of disease at the 90 day clinical and cystoscopy assessment. This patient has met study endpoints demonstrating achievement of the primary, secondary and exploratory endpoints at 90 days post treatment.
The sixth patient was treated in February 2018. Patient No. 6's 90-day clinical cystoscopy assessment to rule out recurrent NMIBC has now been completed and as reported today, the patient has demonstrated no clinical evidence or presence of disease.
The anti-cancer 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 the PDC to be preferentially absorbed by NMIBC tumours. The bladder is then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. A fibre optic assembly, known as a dosimetry fibre optic cage with the ability to both emit and detect laser light, is inserted through the cystoscope, to activate the absorbed PDC, for the intended destruction of the NMIBC tumours.
The company is planning to meet with its medical and scientific advisory board in May 2018 to discuss the results of the Phase Ib study and to finalize the design of a Health Canada and FDA Phase II NMIBC clinical study, with a primary endpoint of efficacy.
About Theralase Technologies Inc.
Theralasetrademark is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations to safely and effectively destroy various cancers. The company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.
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