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Message: Theralase Commences Phase Ib Clinical Study

Theralase Commences Phase Ib Clinical Study

V.TLT | 1 hour ago

 

 

Theralase Commences Phase Ib Clinical Study


Toronto, Ontario (FSCwire) - Theralase Technologies Inc. (“Theralase®” or the “Company”) (TLT:TSXV) (TLTFF:OTC), 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 it has commenced a Phase Ib clinical study indicated for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”).

The design of the clinical study allows for the initial enrollment of three participants to be treated at a low dose using the light activated PDC, TLD-1433. These three participants will be monitored for thirty days and if the treatment is safe and tolerable, then an additional group of 6 participants will be enrolled at a higher dose and monitored for six months.

The Phase Ib NMIBC clinical trial will evaluate TLD-1433, activated by the TLC-3200 medical laser system in conjunction with the TLC-3400 Dosimetry Fibre Optic Cage, for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement of drug in tissue) and an exploratory endpoint of efficacy.

If the Theralase treatment is safe and tolerable, then a Phase II clinical study will be commenced in Canada, the United States and Europe with a primary outcome measure of efficacy.

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase stated that, “The scientific and pre-clinical data to date has been strongly supportive of commencing a Phase Ib NMIBC clinical study. I look forward to commencing the NMIBC clinical study to investigate whether the successes of this technology preclinically can be translated to a clinical population.”

Roger Dumoulin-White, President and CEO of Theralase stated that, “I am pleased that the Phase Ib clinical study has been allowed to commence and we are able to begin enrolling participants. The screening process takes approximately 2 weeks, so the first patient treated should occur late this year or early next year. I look forward to demonstrating to the medical community what the Theralase PDC anti-cancer technology is capable of.”

About Theralase Technologies Inc.

Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology 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 acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy division researches and develops specially designed molecules called Photo Dynamic Compounds, 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


Read more at http://www.stockhouse.com/news/press-releases/2016/12/09/theralase-commences-phase-ib-clinical-study#zwktHkLgVI7TdxhW.99

 

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