Theralase Successfully Achieves Primary and Secondary Objectives for First Three Patients Treated Using Anti-Cancer Technology for Bladder Cancer



Toronto, Ontario (FSCwire) - Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT: TSXV) (TLTFF: OTC), 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, announced today that the independent Data and Safety Monitoring Board (“DSMB”) has unanimously decided that the primary and secondary objectives for the first part of the Phase Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”) have successfully been met.

 

Princess Margaret Cancer Centre, University Health Network (“UHN”), in accordance with the DSMB’s decision, is now recommended to enroll an additional six patients for the second part of the Study, treating them at a therapeutic dose of the PDC (0.70 mg/kg) for NMIBC using its novel Photo Dynamic Therapy (“PDT”) technology.

 

The DSMB is comprised of three highly regarded, independent uro-oncologists; specifically: Dr. Laurence Klotz of Sunnybrook Health Sciences Centre, Dr. Nathan Perlis of the University of Toronto and Dr. Alexandre Zlotta of Mount Sinai Hospital.

 

The clinical data on the first three patients was presented by Dr. Michael Jewett, Chair of the Medical and Scientific Advisory Board (“MSAB”).

 

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, known as a Dosimetry Fibre Optic Cage (“DFOC”) 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 endpoint of safety and tolerability, secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy.

 

The Study was designed to treat 3 patients at an initial dose of the PDC (0.35 mg/kg) and included initial monitoring for 30 days, according to the endpoint criteria above.

 

The DSMB members have unanimously recommended that the first three patients enrolled and treated in the Study successfully achieved the primary and secondary endpoints of the Study and an additional six patients are now eligible to be enrolled into the Study to be treated at a therapeutic dose of the PDC and monitored for 180 days, according to the endpoint criteria.

 

Dr. Michael Jewett, uro-oncologist at UHN stated that, “I am delighted that a small Canadian company, such as Theralase, has been able to achieve such significant clinical results and in such a short time span. I look forward to Theralase reporting out on the next six patients using the therapeutic dose.”

 

Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase thanks the DSMB members for their independent review of the clinical data and their decision that the primary and secondary endpoints for the PDT treatment have successfully been achieved for the first three patients in the Study and their recommendation to continue the Study by enrolling an additional six patients to be treated at the therapeutic dose. Theralase looks forward to successfully reporting out on the performance to the primary and secondary endpoints for the next 6 patients and also the exploratory objective of efficacy of all nine patients, as more clinical data is collected. Theralase has now successfully transformed from a pre-clinical to a clinical oncology organization.”

 

About Theralase Technologies Inc.

 

Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) 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 .

 

This news release contains "forward-looking statements" which reflect the current expectations of management of the Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the proposed use of proceeds. 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. Many factors could cause the Corporation’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 Corporation 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 Corporation cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Corporation 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.

 

For More Information:

 

Roger Dumoulin-White

President & CEO

1.866.THE.LASE (843-5273) ext. 225

416.699.LASE (5273) ext. 225

rwhite@theralase.com                

www.theralase.com



To view this press release as a PDF file, click onto the following link:
public://news_release_pdf/Theralase05262017.pdf

Source: Theralase Technologies Inc. (TSX Venture:TLT, OTC Pink:TLTFF)

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