Theralase Researchers Receive Government Grant

Jun 28, 2018 at 11:00 AM UTC · Issued by Theralase Technologies Inc.

Toronto, Ontario (FSCwire) - Theralase Technologies Inc. (“Theralase^®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical-stage pharmaceutical company dedicated to the research and development of light-activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations used to safely and effectively destroy cancer is pleased to announce that Theralase researchers; specifically: University Health Network (“UHN”) and the University of Toronto (“UT”) have received an Ontario Research Fund – Research Excellence (“ORF-RE”) grant with a primary mandate of advancing personalized Anti-Cancer Photo Dynamic Therapy (“PDT”) for each individual cancer patient to safely and effectively destroy their particular cancer, while maintaining the highest possible quality of life for them.

UHN and UT were successfully awarded an ORF-RE grant valued at $CAN 4.5 million, with financial and technical support provided by world-class industrial and institutional partners, such as: IBM Canada, Altera (Intel), Theralase and Companion Healthcare Corporation (“CHC”), further supported with funding from the Ontario government’s Ministry of Research and Innovation and Science.

The grant is in support of the project entitled, “Personalized Photodynamic Cancer Therapy Using Robust and Validated Simulation Tools”, which is a collaborative effort to advance personalized anti-cancer PDT for oncology patients in Ontario, Canada and internationally.

The ORF-RE program promotes research excellence of strategic value to Ontario by supporting new leading-edge, transformative and internationally significant research.

Applications are reviewed against the following criteria:

Research Excellence: Scientific merit, quality of research and expertise of the research team

Research Impact: Anticipated value to Ontario in the following three categories:

￮ Commercialization

￮ Economic Benefits

￮ Societal Benefits

Achieving Impact: A plan for achieving research impact

Development of Research Talent: A clear plan for the training of highly qualified personnel

Project Management and Governance: Management of the project, including governance structure, sustainability, budget and milestones

UHN and UT researchers will specifically focus on developing algorithms focused on optimizing and predicting patient response to PDT when treated for a range of cancers, including: bladder, brain, lung, esophagus, head and neck and female reproductive organs. The safety and efficacy of the PDT will be tested and validated initially in animals and with that knowledge, the optimized procedures will be subsequently transferred into various human clinical studies.

The principal investigators are Lothar Lilge Ph.D., Brian Wilson Ph.D. and Vaughn Betz, Ph.D. Drs. Lilge and Wilson are both senior scientists at Princess Margaret Cancer Centre, UHN and Professors of Medical Biophysics at UT. Dr. Betz is a Professor in the Department of Electrical and Computer Engineering at UT and the NSERC/Intel Industrial Research Chair in Programmable Silicon, UT.

They are supported by various national and international scientific and clinical investigators from several institutions in support of their objectives.

The primary focus of the ORF project will be to utilize computer-aided modelling of light transport in biological tissue to provide safe and effective cancer treatments by optimizing the placement and power emission of the light source placed in and around the cancerous tumours used to activate the PDCs with the intent on destroying the cancer as a function of the individual patient’s tumour anatomy and metabolism. This will be optimized by key innovations in the areas of: computer simulation, light source and detector placement, coupled with functional and clinical imaging.

The Ontario Medical Association in a report published in 2015 determined that cancer is the fourth most costly disease in Canada to treat, with brain and bladder cancer topping the list in terms of cost to treat.

Almost one in every two Canadians is expected to be diagnosed with cancer in their lifetime, and one in four Canadians will die from the disease, a 2017 report by the Canadian Cancer Society predicts.

In 2017, an estimated 206,200 Canadians will be diagnosed with some form of cancer and an estimated 80,800 will succumb to their malignancy - making cancer the leading cause of death in Canada, the Canadian Cancer Society said in its annual cancer statistics report.

In 2000, in Canada, total cancer costs amounted to $CAN 17.4 billion, with $CAN 2.6 billion attributed to direct healthcare costs and $CAN 14.8 billion attributed to indirect costs, such as lost productivity and premature death (Hopkins 2010).

Globally, the World Health Organization estimates that cancer accounted for 8.2 million deaths in 2012. The number of cases worldwide is predicted to rise from 14 million in 2012 to 22 million within the next two decades. Currently, 60% of all newly diagnosed cases occur in Africa, Asia, Central and South America and account for 70% of the world’s cancer deaths. Given that age is the main risk factor for being diagnosed with cancer, this trend will accelerate rapidly as some of the world’s major populations are attaining life expectancies close to that of the North American population (79.6 years old in the USA and 81.6 years old in Canada).

Age-adjusted cancer incidence rates have stabilized in Ontario, Canada and other high-income countries, so the economic burden continues to increase due to gains in longevity; however in middle and low-income countries, cancer incidence rates continue to rise, straining health care providers; hence, novel approaches for effective, minimally invasive therapies are needed for all countries, regardless of income level.

The ORF project aims to facilitate the clinical adoption of PDT, a minimally-invasive cancer treatment that utilizes light-activated PDCs coupled with the controlled delivery of light to the tumour site via optical fibres for PDC activation and selective tissue destruction. The main advantage of PDT for the patient is that a single therapy may be able to minimize or even replace multiple: surgeries, radiation treatments or chemotherapy inductions.

The world-class cross-disciplinary team of clinicians, researchers and industry participants assembled for the ORF project were specifically selected to address the technological, clinical and scientific challenges of patient personalized PDT to help smooth transition into routine clinical practice. Surgeons (i.e.: gastrointestinal, urologic, thoracic and neurologic) will contribute their knowledge of unmet needs, current standard-of-care treatments and best practices to determine the optimal placement of PDT light sources to destroy various cancers. The support of experts in medical imaging of both humans and animals will provide detailed anatomical information on each case to be treated and thus enable collaboration on innovative image-based measurements to determine dose personalized parameters.

Researchers with world-renowned experience in optical detection and treatment of disease will bring the required physical, chemical and biological understanding of PDT’s effect on tissue, as well as a wealth of optical techniques for treatment monitoring to minimize outcome variability.

Engagement of a computer engineering research group and industry partners, such as: IBM and Altera (Intel), brings leading-edge, high-speed simulation capabilities, as well as significant experience in optimization algorithms, which will be applied to design robust personalized treatment plans for each patient’s malignancy.

PDC drug and laser device manufacturer Theralase will provide engineering, business and commercialization expertise, with plans to validate the project outcomes through clinical studies and pursue commercialization after requisite clinical regulatory approvals, from both Health Canada and the US FDA.

UHN affiliated CHC will enable preclinical testing in companion animals with cancerous tumours and provide a potential avenue for the commercialization of PDT in the field of veterinary oncology.

Leveraging the team’s expertise and resources, the ORF project aims to develop a comprehensive suite of scientific and clinical data to boost the efficacy and safety of PDT, while supporting Theralase in human clinical studies aimed at achieving widespread adoption of PDT in the destruction of cancer for a range of oncological indications.

Optical technologies that can be commercialized for in-treatment monitoring of light dose and drug activation will help increase efficacy and reduce outcome variability, while a novel software platform for personalized treatment planning and monitoring, which integrates standard and functional medical imaging for drug uptake predictions, tissue responsiveness and simulated light distribution will produce an optimized, robust treatment plan for each patient and enable PDT use on complex malignant cases, while minimizing overall cancer treatment duration and providing improvements in the quality of a patient’s life.

Overall, it is anticipated that these improved planning and monitoring technologies will allow oncological PDT treatments to become more accepted by clinicians, allowing more consistent, safer and efficacious clinical outcomes for the direct benefit of cancer patients and healthcare providers.

Dr. Lilge, lead scientist stated that, “PDT is an approved cancer therapy, but is still not widely employed in oncological treatments due to its complexity and various “moving parts.” The current standard-of-care therapies have or are moving towards personalization, a step now also initiated for PDT. The computational aspects of light-based therapies, such as PDT, are immense and require considerable support, in the form of novel computational and optical hardware, to provide dosimetry input to the computational simulation. The proposed methodology of the ORF project is to adequately validate the technology in animal models prior to undertaking clinical studies, as cancerous tumours in animals provide the most realistic evaluation environment possible. As was noted by the reviewers during the project evaluation, this is a project that requires a broad academic collaboration and the support of key industry players, such as Theralase, to achieve rapid translation into the clinic.”

Dr. Betz, stated that, “PDT has great potential to improve the lives of many oncology patients, as it is minimally invasive, yet still can be highly targeted to the tumour by optimizing the light delivery to the PDC, so that the PDC is activated only in and near the tumour. The ORF project is an exciting collaboration of world experts that brings medical researchers, industry engineers, business personnel, scientific researchers and computational scientists together to create a team able to simulate light propagation and PDC activation in tissue, evaluating thousands of potential light delivery options seamlessly and ultimately guiding oncologists to the best treatment plan for each individual patient.”

Arkady Mandel, M.D., Ph.D., D.Sc. Interim Chief Executive Officer and Chief Scientific Officer of Theralase stated that, “Theralase is pleased to support world-class research aimed at optimizing our patented PDCs in a clinical setting. The peered-reviewed recognition of our technology, as well as the financial and technical support, from the Ontario government and world-class industry players, such as IBM and Altera (Intel) will fast-track the commercialization of Theralase’s PDC technology, which will ultimately directly benefit cancer patients. The ORF project will provide even greater insight and knowledge as to how our patented PDCs localize in tissue and how to optimize both the dose of the PDC and laser light to activate them to provide the highest safety and efficacy for individual patients stricken with this deadly disease. Scientific, medical, engineering, business and computational collaboration, combined with government support, will help not only the Company to commercialize our Anti-Cancer PDT technology, but also help to establish the use of PDT worldwide as an effective and impactful anti-cancer therapy. With so few treatments available and even fewer on the near-term horizon for various cancers, combined with an increase of cancer incidence, the medical community needs to fully embrace the cutting-edge technological advantages that have been developed by Theralase and now with the support of a world-class, multi-disciplinary team of esteemed researchers, scientists and clinicians. Through the ORF grant, the Company is leveraging resources to create value for both cancer patients and shareholders, while advancing our innovative technology through the various clinical stages with an end-game of commercialization. We strongly believe that our innovative PDCs and ground-breaking technologies, as well as the focus and strong work ethic of our teams, will support Theralase on our journey to commercial success."

About Theralase Technologies Inc.

Theralase^® is a clinical stage pharmaceutical company dedicated to the research and development of light-activated Photo Dynamic Compounds and their associated drug formulations to safely and effectively destroy various cancers. The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.

Additional information is available at www.theralase.com and www.sedar.com.

This news release contains "forward-looking statements" which reflect the current expectations of management of the Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding Theralase’s proposed development plans for Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as "may", "would", "could", “should”, "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions have been used to identify these forward-looking statements. These statements reflect management's current beliefs with regards to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including the ability of Theralase to: secure the requisite regulatory approvals to commence, successfully fund and complete oncology clinical studies through their various stages and implement its development plans. Many factors could cause the Corporation’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Corporation with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Corporation cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Corporation disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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:

1.866.THE.LASE (843-5273)

416.699.LASE (5273)

info@theralase.com

www.theralase.com

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Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)

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