Toronto, Ontario – January 9, 2015, Theralase Technologies Inc. (“Theralase”) (TLT:TSXV) (TLTFF: OTC Pink®) announced today a summary of its 2014 scientific achievements published in peer reviewed, high impact scientific journals or presented at international conferences that detail its ongoing commitment to establishing the scientific and preclinical research required to support the launch of its cutting-edge technologies.
In addition, Theralase confirms its 2015 strategic objectives with anticipated timing.
From December 2013 to December 2014, the following peer reviewed papers have been published in high impact scientific journals or presented at international conferences and been globally recognized by the international scientific and medical community:
Photodynamic Inactivation of Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus with Ru(II)-based Type I/ Type II Photosensitizers (Photodiagnosis Photodynamic Therapy, 10(4):615-25, Dec. 2013)
Theralase’s ability to destroy two types of bacteria (Staphylococcus aureus and Methicillin Resistant Staphylococcus aureus (MRSA)) up to 99.99999%, with a new class of Photo Dynamic Compounds (“PDCs”) was considered pivotal by the international community because the PDCs were able to destroy two types of bacteria in both normal and low oxygenated tissue in nanomolar concentrations (micrograms of the PDCs were lethal to bacteria when light activated). The PDCs were proven especially effective in low oxygen environments, where certain types of bacteria and cancer are known to thrive.
Ru(II) Dyads Derived from α-Oligothiophenes: a New Class of Potent and Versatile Photosensitizers for PDT (Coordination Chemistry Reviews, 282–283, 127–138, April 2014)
Theralase’s new class of PDCs incorporates systems that act as dual Type I/II PDCs (able to work in oxygenated and non-oxygenated tissue), opening up the possibility of treating hypoxic (low oxygen) tumours with Photo Dynamic Therapy (“PDT”). These PDCs are remarkable in-vitro binders (localizing to organelles within the cell) and photocleavers (ability to destroy these organelles), leading to cell death, when light activated. They exhibit no damage to cells in the absence of light, supporting their high safety and tolerability. This PDT effect has been translated effectively to animals and has proven superior to FDA approved PDC Photofrin®, in this research. The ability to activate the Theralase PDCs from visible to Near Infra Red (“NIR”) light marks an unprecedented versatility that can be exploited to match treatment depth to tumour target depth, giving rise to PDCs for multi-wavelength activated PDT, that can target superficial as well as deep seated tumours.
In vitro Multi-Wavelength PDT with 3IL states: Teaching Old Molecules New Tricks (Inorganic Chemistry, 5;53(9):4548-59, May 2014)
Theralase’s researchers demonstrated that Theralase’s PDCs can be used for multi-wavelength PDT, as they are able to be activated by blue, green, red, and NIR light, allowing them to act as potent light-sensitive cytotoxic (cell killing) agents for cancer PDT applications in various depths of tissue.
Elicitation of Tumor-free Long-term Survival and Long-Lasting Antitumor Memory with Novel Non-Immunosuppressive Near-Infrared PDT (Presented at 37th Annual American Society for Photobiology, San Diego, California, June 2014)
Theralase researchers presented data that mice injected with 350,000 colon cancer cells (producing tumours approximately five millimeters in size) that were treated with an intra-tumoural injection of Theralase’s lead PDC and illuminated by NIR light to activate the PDC produced results where a vast majority of the tumours were completely destroyed, with the PDC treatment demonstrating prolonged tumour regression.
In follow on research, the same mice who received the initial, successful PDT were re-injected with the same number of colon cancer cells, 13 to 23 days later. With no further treatment intervention, mice in these experiments, demonstrated either a small tumour regrowth, which quickly regressed, or in the majority of animals, no tumour regrowth at all, suggesting a short-term immune-mediated (immune “memory response”) tumour rejection.
To further prove the resilience of the PDT treatment, these same animals were then injected a third time with an additional 350,000 colon cancer cells at ten months post PDT treatment. None of these animals showed any sign of tumour regrowth, even at 3 months post follow up, suggesting the presence of a long-term anti-tumour immunity, responsible for complete tumour rejection.
To strengthen the data, control experiments were conducted where age matched mice without prior tumour exposure or PDT treatment were injected with the same number of colon cancer cells, where the majority of these mice proceeded to develop tumours and did not survive more than 1 month following the injection.
In November 2014, the initial data was further validated showing that mice who received the initial, successful PDT were re-injected with an equal number of colon cancer cells, 20 days later. With no further treatment intervention, 100% of the mice in these experiments demonstrated 0% tumour regrowth, suggesting an optimization to the short-term immune-mediated (immune “memory response”) tumour rejection.
The initial results have now been validated and optimized by Theralase researchers with a new set of animals confirming the immune-mediated (immune “memory response”) tumour rejection. This anti-cancer memory response suggests a major breakthrough in cancer research and may provide substantial treatment benefit and survival advantage to cancer patients. Technology that is able to rapidly and effectively destroy “patient-specific” cancer cells, prevent their recurrence and provide long lasting protection against local and distant metastasis, offers immense clinical benefit to cancer patients and the facilities that treat their disease.
Ru(II) Dyads Derived from 2-(1-Pyrenyl)-1H-Imidazo[4,5-f][1,10] Phenanthroline: Versatile Photosensitizers for Photodynamic Applications (Journal of Physical Chemistry, 13;118(45):10507-21, November 2014)
Theralase researchers demonstrated that their new class of PDCs exhibited nanomolar (micrograms of PDCs) light cytotoxicities (cell kill) against cancer cells. This potency extended to bacteria. The results from this study demonstrate the versatility of these highly potent photosensitizers in destroying both cancer and bacterial cells and expand the scope of compounds that utilize low-lying states for photobiological applications.
Roger Dumoulin-White, President and CEO of Theralase stated that, “I am pleased that our research scientists have been able to accomplish such dramatic milestones in our scientific and preclinical research in 2014. I am confident that 2015 will bring even more dramatic advances in both our Therapeutic Laser Technology (“TLT”) and Photo Dynamic Therapy (“PDT”) Anti-Cancer Divisions”, as we progress our leading technologies to market.
In 2015, Theralase plans to execute on the following strategic objectives:
In the TLT Division, Theralase will launch the patented, next generation TLC-2000 biofeedback therapeutic laser system in Canada in 1Q2015 and in the US in 2Q2015. Theralase had anticipated launching the TLC-2000 in 4Q2014, but due to increased testing and regulatory requirements brought on by new international testing standards, launch was slightly delayed to allow the Company time to complete its mandatory regulatory testing.
In the PDT Division, Theralase will commence clinical testing of its lead PDC in humans via a Health Canada / FDA Phase I / II a bladder cancer clinical study for Non Muscle Invasive Bladder Cancer (“NMIBC”) in 2015.
Strategic objectives in 2015 to accomplish this task include:
- Optimization of the dose of laser light and PDC required in its orthotopic rat model to further refine this procedure for the destruction of bladder cancer in a live animal model. Preliminary results reported in 4Q2014 were excellent demonstrating: localization of the PDC to bladder cancer tumours, destruction of bladder cancer upon light activation, no impact to healthy bladder tissue during treatment and a very high safety profile, evidenced by virtually no PDC being absorbed into the blood stream (1Q2015)
- Conduct Health Canada Clinical Trial Application (“CTA”) / Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) meetings (1Q2015)
- Complete pre-Good Manufacturing Practices (“GMP”) and GMP manufacture of lead drug (2Q2015)
- Identification of toxicity laboratory and completion of toxicity analysis of the lead compound in 2 different animal species (2Q2015)
- Health Canada and FDA CTA / IND Regulatory Approval (2Q2015)
- Commence enrolling subjects into Health Canada / FDA Phase I / II a bladder cancer clinical study for NMIBC (Pending Regulatory Approval)
About Theralase Technologies Inc.
Founded in 1994, Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC Pink®) designs, manufactures and markets patented super-pulsed laser technology used for the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing. Theralase has sold over 1,200 systems to licensed healthcare practitioners, including: medical doctors, chiropractors, physical therapists and athletic therapists. Theralase has been so successful in healing nerve, muscle and joint conditions in clinical practice that Theralase’s scientists and clinicians have now turned their attention to investigating the application of its lasers in the destruction of cancer. Using specially designed molecules, Theralase uses Photo Dynamic Compounds (“PDCs”) to localize inside the cancer cells and when light activated, destroy them.
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.
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For More Information:
President & CEO, Theralase Technologies Inc.
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225