Toronto, Ontario – September 9, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that its latest research demonstrates that its lead Photo Dynamic Compound (“PDC”), TLD-1433, in addition to being indicated for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”), may also be effective for the treatment of Muscle Invasive Bladder Cancer (“MIBC”).
The latest research involved testing the Photo Dynamic Therapy (“PDT”) of TLD-1433 in an orthotopic rat bladder tumour model.
Procedure:
– 5 million AY27 rat bladder cancer cells per milliliter were instilled in the sensitized rat bladder for one hour to allow the cancer cells to attach.
– Tumours required two to three weeks to grow to an appropriate size
– TLD-1433 was intravesically infused into the rat’s bladder at either 0.6 mgmL-1 (representative of human low dose) or 6.0 mgmL-1 (representative of human high dose)
– After one hour incubation, TLD-1433 was removed and the bladder was washed three times with sterile water to remove any unabsorbed TLD-1433 mirroring the proposed human clinical treatment
– An optical fiber was inserted into the center of the rat bladder to deliver green laser light for PDT, at a dose of 90 Jcm-2 again mirroring the human treatment
– Experiments were performed with drug only and light only controls to exclude any possibility that drug or light alone led to cell kill
– The rats were sacrificed two days post-PDT and their bladders were sent to the histopathology lab for analysis
Results (Representative of Human Low Dose):
– Five tumours treated with 0.6 mgmL-1 TLD-1433 (representative of human low dose) followed by PDT showed a strong response to the PDT with complete destruction of the tumour, with large areas of hemorrhage, necrosis (cell kill), and inflammation present throughout the whole depth of the tumour.
– Blood vessels of the submucosa, the muscle layer, and urothelium distal from the tumour area were unaffected by the PDT.
– Drug or light only controls showed no effect on the destruction of the tumour.
Representative image of drug only control (A), light only control (B), and PDT treated (C) tumours. Upper row shows zoomed in view, with lower row showing full bladder thickness images. In all cases, the scale bar represents 100 µm. In the control tumours, tumour nuclei are well defined and closely packed. Two days after PDT treatment, the tumour mass shows widespread hemorrhage and inflammation, with an absence of cancer cells. The dark spots in the treated tumours are neutrophils responding to the widespread cell death and inflammation. Full thickness sectioning shows a completely necrotic (cell kill) tumour. The urothelium and the deeper muscle layers adjacent to the tumour are intact.
Results (Representative of Human High Dose):
Three tumours treated with 6.0 mgmL-1 TLD-1433 (representative of human high dose) followed by PDT showed a strong PDT specific response with complete destruction. TLD-1433 mediated PDT was able to induce full depth tumour necrosis (cell kill) across 2 to 3 mm deep tumours. Furthermore, TLD-1433 was able to induce full depth tumour necrosis in MIBC tumours, showing the wide versatility of TLD-1433 to treat bladder cancer across various progression stages.
Representative images of control (A) and PDT treated tumours (B). Top row shows the macro image of the tumour, with the arrowhead pointing to the tumour. Bottom row shows histological sectioning of the tumours from the first row. All scale bars represent 1 mm. The control tumour shows unabated growth, reaching a thickness of 2 to 3 mm of highly packed proliferating cells. The tumour PDT treated with 6 mgmL-1 TLD-1433 shows full depth necrosis of the whole 2 to 3mm deep tumour. This necrosis is evident even at macroscopic observation, with the full tumour showing a deep red color.
Representative image of MIBC in control (A) and PDT treated (B) bladders. In all images, the scale bar represent 0.5 mm. In the control, the highly proliferative cancel cells have infiltrated the deeper muscle layer in multiple locations. In the PDT treated bladder with 6.0 mgmL-1 TLD-1433, the tumour had invaded the muscle layer, but has become completely necrotic (cell kill) due to PDT treatment. The muscle and urothelial tissue flanking the tumor remains healthy and do not show signs of inflammation or necrosis.
Roger Dumoulin-White, President and CEO, Theralase stated that, “This is a very significant finding as there are 75,000 Americans and 8,000 Canadians diagnosed with bladder cancer every year. Of these individuals 70% present with early stage disease (NMIBC) with the other 30% present with more advanced cancer (MIBC). If this research can successfully be translated clinically, then not only will TLD-1433 be able to successfully treat NMIBC, it may also be indicated to successfully treat MIBC, without any impact to healthy tissue.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology Division designs, manufactures and markets patented super-pulsed laser technology indicated for 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 Division researches and develops specially designed molecules called Photo Dynamic Compounds, which are able to 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.
Theralase Technologies Inc. was recognized as a TSX Venture 50® company in 2015. TSX Venture 50 is a trademark of TSX Inc. and is used under license.
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Michael Borovec
Director of Investor Relations
1.866.THE.LASE (843-5273) ext. 222
416.699.LASE (5273) ext. 222