Toronto, Ontario (FSCwire) - Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotech 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 fourth patient was treated, utilizing the Therapeutic Dose (0.70 mg/cm2) on July 20, 2017 for Non-Muscle Invasive Bladder (“NMIBC”) cancer using its novel Photo Dynamic Therapy (“PDT”) technology.

 

These 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 Phase Ib NMIBC clinical study (“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 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, 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 endpoints of safety and tolerability, a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.

 

The Study has demonstrated success in the treatment of the first 3 patients at the Maximum Recommended Starting Dose (“MRSD”) of the PDC (0.35 mg/cm2) and achieved the primary, secondary and exploratory endpoints at the 90 day cystoscopy analysis timepoint.

 

The exploratory outcome endpoint in the Study is Recurrence-Free Survival (“RFS”), 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.

 

Patient number 4 represents the first of an additional 6 patients to be enrolled and treated in the Study at the Therapeutic Dose of the PDC and evaluated according to the approved clinical protocol.

 

Roger Dumoulin-White, President and CEO of Theralase stated that, “The Company is pleased that it has successfully executed on the first part of the Study and has now advanced to the second part of the Study; specifically, the enrollment and treatment of an additional 6 patients at the Therapeutic Dose of the PDC. Theralase looks forward to successfully executing on the second part of the Study and will report out on its progress, as appropriate.”

 

About Theralase Technologies Inc.

Theralase Technologies Inc. (“Theralase®” or the “Company”) (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 .

 

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/theralase08012017.pdf

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