Theralase® Anti-Cancer Technology Effective in Destroying Brain Cancer Stem Cells
Toronto, Ontario – March 15, 2018
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 to safely and effectively destroy various cancers, announced today that its lead PDC, TLD-1433, combined with transferrin to form Rutherrin®, has been demonstrated to effectively destroy human brain cancer stem cells.
Despite tremendous advances in cancer therapy over the last ten years, resistance to treatment and high rates of recurrence remain stubbornly common.
In fact, even patients who experience a complete clinical response to frontline therapy (i.e.: surgery, radiation or chemotherapy), often suffer a relapse with the emergence of lethal, drug-resistant disease—stemming in large part from microscopic deposits of surviving cancer cells that escaped treatment by various mechanisms. This is commonplace for malignancies of the bladder and brain.
The contribution of cancer stem cells to the formation of cancers has been previously established in the clinical literature and has been described for several solid tumours.
Although a combination of surgery, radiation and chemotherapy may destroy most of cancer cells in a tumour, it is believed that the cancer cells left alive may in fact be cancer stem cells, capable of reforming the tumour. If able to be destroyed, the destruction of these cancer stem cells may represent an extremely important discovery in defeating cancer’s resistance to treatment and more importantly, recurrence.
GlioBlastoma Multiforme (“GBM”) is the most common and aggressive primary brain tumour and unfortunately has one of the worst survival rates of all types of cancer.
Despite aggressive surgery, radiation and chemotherapy, these tumours, virtually all become resistant to therapy and as a result recur.
There are an estimated 24,000 new cases of malignant gliomas diagnosed in the US annually, with more than 14,000 deaths. Most patients do not survive beyond 2 years, post diagnosis.
The cancer stem cells within these aggressive tumours are hypothesized in the latest clinical research to be responsible for the observed resistance to treatment and recurrence.
In the Company’s latest research, Theralase® research scientists have tested the effect of Rutherrin® Photo Dynamic Therapy (“PDT”) on GSC-118 cancer cells, an established human GBM cancer stem cell line.
In previous research, TLD-1433 has been shown to successfully kill human GBM brain cancer cells in-vitro (U87 cell line).
In the latest research, Theralase® has demonstrated the ability of Rutherrin® PDT to destroy GSC-818 brain cancer stem cells in the 300 to 600 nM range, when activated by green laser light (520 nm / 20 J/cm2).
Figure 1. Effect of Rutherrin® PDT on GSC-818 GBM cancer stem cell line
Pavel Kaspler, Ph.D., Research Scientist at Theralase® stated that, “GSC-818 GBM cancer stem cells have been completely destroyed by Rutherrin® PDT at concentrations that are up to ten times lower (300 to 600 nM) than those levels detected by mass spectrometry in previously reported Theralase® research for the treatment of orthotopic rat GBM tumours utilising the RG2 animal model (3 uM). Another important observation is that the destruction of these GBM brain cancer cells was completed at light doses 4.5 times less than that used for PDT in animals and clinically (20 J/cm2 versus 90 J/cm2). These important discoveries are allowing our team to optimize GBM treatments preclinically to allow translation of this technology to a Phase Ib GBM clinical study using Rutherrin® PDT and our latest discovery, the cancer vaccine.”
Arkady Mandel, MD, Ph.D, D.Sc., Interim Chief Executive Officer and Chief Scientific Officer stated that, “I believe that the presence of glioma stem cells within various types and grades of gliomas is one of the main reasons that they are so difficult to destroy. The Theralase® research presented here today supports the efficacy of Rutherrin® PDT in the destruction of human GBM cancer stem cells and is of significant clinical and scientific interest. GBM is the most common and unfortunately most aggressive primary brain cancers. The current initial standard of care consists of surgical resection followed by radical radiotherapy and adjuvant temozolomide chemotherapy. Despite optimal therapy, median survival is approximately 14 months from diagnosis and less than 6 months for patients with recurrent disease; therefore, today’s clinical treatments remain palliative in nature and not curative. The latest scientific and clinical published research suggests that continued GBM tumour growth and recurrence is due in a large part to the presence of resistant glioma stem cells, which display self-renewal and hence the highest probability of transforming themselves into an aggressive GBM. Moreover, recurrent GBM disease may be a consequence of the enhancement and/or gain of stem cell-like characteristics during disease progression, signifying that the cancer stem cells phenotype is a crucial therapeutic target. Our success in the destruction of GSC-818 GBM human cancer stem cells achieved today is a major accomplishment that the Company plans to exploit to optimise this technology preclinically with the aim of effectively translating this information clinically in the form of a Phase Ib GBM clinical study focused on improved patient survival and / or development of an effective frontline treatment for this deadly disease.”
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) 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.
This news release contains “forward-looking statements” which reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company’s development and commercialization of the TLC-2000, including with respect to ongoing redesign work and regulatory clearance process for expanded claims and the Company’s development and commercialization strategy with respect to its Anti-Cancer Technology. 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 respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to successfully complete the redesign work under the proposed timeframe and scope of work or at all, the availability of financing to advance the development of the TLC-2000, the ability of the Company to secure further regulatory clearances (including with respect to expanded claims) from Health Canada and/ or the FDA with respect to the TLC-2000 under the proposed timeframe and scope or at all, the ability of the Company to achieve wider commercial distribution of the TLC-2000, the ability of the Company to execute its strategy with respect to its Anti-Cancer Technology, the ability of the Company to secure further regulatory approvals from Health Canada and/ or the FDA for its NMBIC clinical studies and the ability of the Company to finalize development of, and successfully commercialize, its Anti-Cancer Technology. Many factors could cause the Company’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 Company 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 news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company 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.
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