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 .
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