Theralase® Provides Update on Phase Ib Non-Muscle Invasive Bladder Cancer Clinical Study
Patient Five Shows No Clinical Evidence or Presence of NMIBC at 90 Day Cystoscopy Analysis
Patient Six Shows No Clinical Evidence or Presence of NMIBC to Date
Toronto, Ontario – April 16, 2018
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 determined by Recurrence-Free Survival, 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 (i.e. any biopsy-confirmed new or recurrent tumour), evaluated at ninety (90) days for the first three patients treated at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) and primarily at ninety (90) days for the last six patients treated at the Therapeutic Dose (0.70 mg/cm2) and secondarily one hundred and eighty (180) days post treatment. Patients who have exceeded the 180 day timeline are no longer monitored as part of the Study.
As previously reported, three patients have successfully been treated at the MRSD (0.35 mg/cm2) showing achievement of the primary, secondary and exploratory endpoints at 90 days post treatment.
The latest three patients, patient four, five and six have been treated at the Therapeutic Dose (0.70 mg/cm2).
The fourth patient developed metastatic urothelial carcinoma, that was detected during a Trans-Urethral Resection of the Bladder Tumour procedure, 138 days after Study treatment. While unusual for NMIBC to metastasize directly to the bone, cases of such progressive disease are known to occur. Given the rapidity of metastases, the treating physicians hypothesize the presence of undetected micro-metastases in the bone were present at the time of Study treatment. Although there was no progressive disease in the bladder, there was evidence of bladder recurrence after treatment. The primary endpoint of safety was nevertheless met in this patient as the therapy was well tolerated with minimal toxicity. The secondary endpoint of pharmacokinetics was also achieved.
The Company, in conjunction with its clinical partner, have optimized the clinical procedure of the Study commencing with patient number five.
As previously reported, the fifth patient was enrolled and treated in January 2018. At the 90 day cystoscopic assessment, completed in April 2018, no tumour recurrence or presence of disease was
detected. This patient has now met Study endpoints showing achievement of the primary, secondary and exploratory endpoints at 90 days post treatment.
The sixth patient’s 90-day cystoscopy analysis will be completed in May 2018 to rule out recurrent NMIBC. To date, the patient has shown 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.
Three additional patients remain to be enrolled and treated at the Therapeutic Dose to complete the Study, although patients have been identified.
The Company is planning to meet with its Medical and Scientific Advisory Board (“MSAB”) in May 2018 to finalize the design of a Health Canada and FDA Phase II NMIBC clinical study, with a primary endpoint of efficacy, subject to Health Canada regulatory approval of the current Study.
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) 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.
This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s development and commercialization of the TLC-2000, including with respect to ongoing redesign work and regulatory clearance process for expanded claims and the Company’s development and commercialization strategy with respect to its Anti-Cancer Technology. Wherever possible, words such as “may“, “would“, “could“, “should”, “will“, “anticipate“, “believe“, “plan“, “expect“, “intend“, “estimate“, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to successfully complete the redesign work under the proposed timeframe and scope of work or at all, the availability of financing to advance the development of the TLC-2000, the ability of the Company to secure further regulatory clearances (including with respect to expanded claims) from Health Canada and/ or the FDA with respect to the TLC-2000 under the proposed timeframe and scope or at all, the ability of the Company to achieve wider commercial distribution of the TLC-2000, the ability of the Company to execute its strategy with respect to its Anti-Cancer Technology, the ability of the Company to secure further regulatory approvals from Health Canada and/ or the FDA for its NMBIC clinical studies and the ability of the Company to finalize development of, and successfully commercialize, its Anti-Cancer Technology. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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