RE:Theralase Anti-Cancer Technology Used to Treat Fifth Patient Bbbenny, could u explain diff between maximum and therapeutic doses?? I'm getting confused??? Help Clueless , do u have an answer ????
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"Three patients have been enrolled and treated at the Maximum Recommended Starting Dose (0.35 mg/cm2)."
Toronto, Ontario – January 18, 2018, 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 when used in conjunction with Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that the fifth patient in a Phase Ib Non-Muscle Invasive Bladder (“NMIBC”) clinical study (“Study”) was enrolled and treated on January 11, 2017, using the Company’s anti-cancer Photo Dynamic Therapy (“PDT”) technology.
The anti-cancer 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 the PDC to be preferentially absorbed by NMIBC tumours. The bladder is then drained of the solution, flushed with sterile water to remove non-absorbed solution and refilled with sterile water via a cystoscope. 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 absorbed PDC, for the intended destruction of the NMIBC tumours.
The Study is being used to evaluate TLD-1433 for the primary endpoint of safety and tolerability, a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.
Three patients have been enrolled and treated at the Maximum Recommended Starting Dose (0.35 mg/cm2).
Two patients have been enrolled and treated at the Therapeutic Dose (0.70 mg/cm2), with an additional four patients remaining to be enrolled and treated at the Therapeutic Dose to complete the Study.
If Health Canada regulatory approval of the Study is achieved, subject to Health Canada and FDA regulatory approval, the Company plans to commence a multi-center Phase II NMIBC clinical study, with a primary endpoint of efficacy.
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 and proprietary super-pulsed laser technology indicated for the treatment of 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 (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which localize inside cancer cells and then when laser light activated are intended to effectively destroy them.
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