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Theralase Technologies announced the Data and Safety Monitoring Board ruled favorably for the company’s Phase Ib non-muscle invasive bladder cancer clinical study.
Theralase Technologies (TSXV:TLT, OTCPINK:TLTFF) announced the Data and Safety Monitoring Board ruled favorably for the company’s Phase Ib non-muscle invasive bladder cancer clinical study.
As quoted in the press release:
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.
Click here to read the full press release.