Theralase® Anti-Cancer Technology Shows Promise for Esophageal Cancer Using Targeted Molecular Delivery System

Theralase® Affiliated Researchers Present New Data that Demonstrates the Application of Theralase’s Lead Photo Dynamic Compound,
TLD-1433, in the Destruction of Gastrointestinal Dysplasia and Esophageal Cancer.

Toronto, Ontario – October 9, 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 intended to safely and effectively destroy various cancers announced today that Theralase affiliated researchers have presented immunohistochemical analytical data supporting the use of TLD-1433 Photo Dynamic Therapy (“PDT”) in the destruction of gastrointestinal dysplasia and esophageal cancer.

Esophageal carcinoma, including Squamous Cell Carcinoma (“SCC”) and adenocarcinoma, is a leading cause of cancer related deaths worldwide. While SCC arises through progression from Low Grade Dysplasia (“LGD”) to High Grade Dysplasia (“HGD”), adenocarcinoma is preceded by Barrett’s metaplasia followed by low and then high grade dysplastic changes. There is poor inter-observer variability amongst pathologists in the diagnosis of precursor dysplastic lesions of the esophagus. Moreover, prognosis for esophageal cancer remains poor throughout the world. In selected centers and in subgroups of patients who undergo radical esophagectomy, 5-year survival rates of 40% or above could be achieved. A selection bias is difficult to disprove and such encouraging results are infrequently seen. In most reports, a 20% 5-year survival rate is recorded; therefore, there is a need for new biomarkers and advanced, effective, targeted and personalised methods to facilitate accurate diagnosis and treatment of Barrett’s esophagus and esophageal cancer 1.

Dr. Norman Marcon, MD, FRCP, Professor of Medicine in University of Toronto, Chief of Gastroenterology for St. Michael’s Hospital, Toronto, Ontario stated, “This research was inspired by Theralase’s research into the role of the human glycoprotein Transferrin (“Tf”) and its associated cellular membrane Transferrin Receptor (“TfR”) CD71, that according to previous Theralase® research is responsible for the targeted uptake of Theralase’s lead PDC, TLD-1433, by cancer cells. The aim of our research was to characterize CD71 expression in human samples of esophageal carcinomas and their precursor lesions. Remarkably, moderate to strong CD71 staining was seen almost universally (97.2%) in both SCC and adenocarcinoma. There was a significantly stronger expression of CD71 in HGD and carcinomas versus LGD and normal squamous mucosa tissues (p <0.02). This research is exciting as we now have a way to distinguish between LGD and HGD lesions. Moreover, CD71 is an important target for Rutherrin® (TLD-1433 combined with transferrin) and hence the development of an effective, targeted and highly personalised PDT destruction of HGD precursor lesions and cancers of the esophagus. This latest research was presented and well received at the annual Canadian Academy of Pathology Meeting held in Quebec City, Quebec, Canada from July 7 to 10, 2018. Our therapeutic endoscopy group is looking forward to continuing our research with Theralase® to clinically evaluate this technology in a Phase Ib clinical study aimed at the destruction of esophageal cancer.”

 

Figure 1. Immunohistochemical Chemical Analysis of CD71 in High Grade Dysplasia and Invasive Squamous Cell Carcinoma 

 

Figure 2. Immunohistochemical Chemical Analysis of CD71 in Glandular Dysplasia and Adenocarcinoma of the Esophagus

1 So B, Marcu L, Olver I, Gowda R, Bezak E. Oesophageal cancer: Which treatment is the easiest to swallow? A review of combined modality treatments for resectable carcinomas. Crit Rev Oncol Hematol.;113:135-150, 2017.

 

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.

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 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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