Theralase® Successfully Completes Phase Ib Non-Muscle Invasive Bladder Cancer Clinical Study
Theralase Medical and Scientific Advisory Board concluded that the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”) has met its objectives and unanimously voted for the early termination of the Study based on successfully achieving its primary and secondary endpoints after six patients.
Toronto, Ontario – May 30, 2018
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy cancer has successfully completed the Study.
On May 19, 2018, Theralase’s Medical and Scientific Advisory Board (“MSAB”) was convened to examine the clinical results obtained on the first six patients enrolled and treated in the Study utilizing TLD-1433-based Photo Dynamic Therapy (“PDT”); specifically: the primary endpoint of safety and tolerability, the secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and the exploratory endpoint of efficacy primarily at 90 days.
The MSAB is comprised of world-renowned experts in bladder cancer and have been retained by the Company to provide advice and strategic guidance on the research, development and commercialization of the TLD-1433-based PDT technology in the treatment of patients inflicted with NMIBC.
After reviewing the clinical data presented by Girish Kulkarni, MD, PhD, FRCSC, an Associate Professor at the University of Toronto, Department of Surgery and the Principal Investigator of the Study, the MSAB unanimously recommended the early termination of the Study due to achievement of the primary and secondary endpoints. The MSAB also recommended that the clinical data collected from the first three patients treated at the Maximum Recommended Starting Dose (“MRSD”) (0.35 mg/cm2) and the three patients treated at the Therapeutic Dose (0.70 mg/cm2) were sufficient to support the conclusion that the Study had successfully achieved the Study’s primary and secondary endpoints and had adequately addressed the Study’s scientific, technical and clinical questions, as per the approved Study design and clinical protocol. The MSAB recommendation to the Company was to terminate the Study based on the six patients treated to date and suggested that the Company pursue a pivotal Phase II NMIBC clinical study approval with Health Canada and the FDA with efficacy as the primary endpoint.
Dr. Kulkarni stated that, “The primary and secondary endpoints of the Study have been successfully accomplished from a clinical aspect. The treatment was safe and well tolerated by all patients treated, with no discernible difference in the number or severity of Adverse Events (“AEs”), regardless of whether the MRSD or Therapeutic Dose was utilized. All AEs were either minor (Grade 1) or moderate (Grade 2) in severity and completely resolved within 90 days. There were no severe (Grade 3), life threatening (Grade 4) or deaths (Grade 5) AEs and the majority of AEs were transient and related to irritative lower urinary tract symptoms (i.e.: urination urgency). TLD-1433 systemic absorption was minimal (picograms concentration in plasma), which is magnitudes below the No Observed Adverse Effect Level (“NOAEL”) for TLD-1433 and hence presents no significant clinical risk. I believe that TLD-1433 holds real potential as a treatment for NMIBC and I look forward to treating patients in a pivotal Phase II NMIBC clinical study, pending Health Canada approval to commence the study.
Michael Jewett, MD, FRCSC, FACS, Professor of Surgery (Urology) at the University of Toronto and the Chairman of Theralase’s MSAB stated that, “When NMIBC intravesical treatment with Bacillus Calmete Guérin (“BCG”) fails, the standard of care is cystectomy (removal of the patient’s bladder), which is a major surgery with life-altering side effects that many patients may not accept despite the risk of cancer spread. The Study clinical data presented by Dr. Kulkarni is very encouraging. TLD-1433 PDT appears safe and well-tolerated in patients presenting with BCG-Unresponsive NMIBC. I am pleased that the clinical results of the Study met its objectives demonstrating that the Theralase PDT technology has demonstrated potential as a treatment for bladder cancer. The MSAB members and I unanimously support the view that the Study achieved its primary and secondary endpoints after the treatment of 6 patients and concluded that the clinical data collected supports an early termination of the Phase I Study to commence a pivotal Phase II NMIBC clinical study focused on efficacy. The Phase II NMIBC study design has been discussed and collectively approved during the MSAB meeting. The exploratory endpoint of efficacy is extremely encouraging as the fifth and sixth patients are clinically cancer free as of the ninety day cystoscopy examination.”
Ashish Kamat, MD, MBBS, Professor of Urologic Oncology (Surgery) and Wayne B. Duddlesten Professor of Cancer Research, University of Texas, MD Anderson Cancer Center stated that, “The safety data presented by Dr Kulkarni and Theralase is convincing and recruitment of an additional three patients at the Therapeutic Dose is not likely to add significant value to the understanding of the PDT technology in the treatment of NMIBC. If a larger multicenter study demonstrates efficacy of PDT technology in this patient population, it would provide our patients a useful alternative to avoid radical surgery. The more safe, reliable options we have to offer our patients, the better it is for everyone concerned. The MSAB thus recommended that the Company truncate the Study early to seek Health Canada and FDA approval to commence a larger and more statistically powered, single arm, multicenter efficacy study. Moreover, the MSAB reviewed and approved in principle the Phase II clinical protocol and the clinical study design presented by Dr. Jewett. BCG-Unresponsive NMIBC is a potentially fatal disease that requires additional treatment options. Currently, cystectomy remains the safest treatment option available to patients, but if the Theralase PDT achieves its efficacy endpoint in a Phase II clinical study, then this will present patients with an attractive additional treatment option. The clinical data presented by Dr. Kulkarni suggests that the Theralase PDT treatment option may be just what the doctor ordered.”
Michael O’Donnell, MD, Professor of Urology, University of Iowa, Iowa City, Iowa stated, “I’m encouraged by the Theralase Phase Ib clinical study data presented at the MSAB meeting. The top-line clinical results indicate that the TLD-1433-based PDT at tested doses has met its primary and secondary objectives in the studied population of BCG-Unresponsive patients with NMIBC who refused cystectomy. The Theralase approach is an interesting treatment option with an early signal of treatment effectiveness, albeit in a small population, that will need to be confirmed in a Phase II clinical study. This is a novel approach that addresses a bladder cancer population with a high unmet need. As designed, a successful Phase II clinical study will confirm how this PDT therapy approach could shape future practice.”
About the Study
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.
Study Outcome Endpoints:
1) Primary: Evaluate safety and tolerability. (Measured by patients who experience Adverse Events (“AEs”) Grade 4 or greater that do not resolve within thirty (30) days; whereby: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe AE, Grade 4 = Life-threatening or disabling AE, Grade 5 = Death)
2) Secondary: Evaluate the pharmacokinetics. (movement and exit of drug within tissue) of TLD-1433 (Measured by TLD-1433 concentration levels in plasma and urine over 72 hours.)
3) Exploratory: Evaluate efficacy. (Measured by Recurrence Free Survival (“RFS”), defined as the interval from Day 0 (Day of PDT treatment) 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 90 days for the first three patients treated at the MRSD and primarily at 90 days for the last six patients treated at the Therapeutic Dose and secondarily at 180 days post treatment)
The Company is planning to meet with Health Canada and FDA, to discuss and finalize the design of a Health Canada and FDA pivotal Phase II NMIBC clinical study, with a primary endpoint of efficacy.
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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