Theralase Successfully Achieves Primary and Secondary Objectives for First Three Patients Treated Using Anti-Cancer Technology
for Bladder Cancer
Toronto, Ontario (FSCwire) - Theralase Technologies Inc.
(“Theralase®” or the “Company”) (TLT: TSXV) (TLTFF: OTC), a
leading biotechnology 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 independent Data and Safety Monitoring
Board (“DSMB”) has unanimously decided that the primary and secondary objectives for the first part of the Phase
Ib Non-Muscle Invasive Bladder Cancer (“NMIBC”) clinical study (“Study”) have successfully been
met.
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.
The Study is being used to evaluate TLD-1433 for the: primary endpoint of safety and tolerability, secondary
endpoint of pharmacokinetics (movement and exit of drug within tissue) and exploratory endpoint of efficacy.
The Study was designed to treat 3 patients at an initial dose of the PDC (0.35 mg/kg) and included initial
monitoring for 30 days, according to the endpoint criteria above.
The DSMB members have unanimously recommended that the first three patients enrolled and treated in the Study
successfully achieved the primary and secondary endpoints of the Study and an additional six patients are now eligible to be
enrolled into the Study to be treated at a therapeutic dose of the PDC and monitored for 180 days, according to the endpoint
criteria.
Dr. Michael Jewett, uro-oncologist at UHN stated that, “I am delighted that a small Canadian company, such as
Theralase, has been able to achieve such significant clinical results and in such a short time span. I look forward to Theralase
reporting out on the next six patients using the therapeutic dose.”
Roger Dumoulin-White, President and CEO of Theralase stated that, “Theralase thanks the DSMB members for their
independent review of the clinical data and their decision that the primary and secondary endpoints for the PDT treatment have
successfully been achieved for the first three patients in the Study and their recommendation to continue the Study by enrolling
an additional six patients to be treated at the therapeutic dose. Theralase looks forward to successfully reporting out on the
performance to the primary and secondary endpoints for the next 6 patients and also the exploratory objective of efficacy of all
nine patients, as more clinical data is collected. Theralase has now successfully transformed from a pre-clinical to a clinical
oncology organization.”
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 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
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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/Theralase05262017.pdf
Source: Theralase Technologies Inc. (TSX Venture:TLT, OTC Pink:TLTFF)
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