Theralase Granted FDA Fast Track Designation for NMIBC Phase II Clinical Study
Monday, November 23, 2020 7:00 AM

TORONTO, ON / ACCESSWIRE / November 23, 2020 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that the U.S. Food and Drug Administration ("FDA") has granted Theralase® Fast Track Designation ("FTD") for its Phase II Bacillus Calmete Gurin ("BCG")-Unresponsive Non Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In Situ ("CIS") clinical study ("Study II").

As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase's development plans and ensure timely collection of the appropriate clinical data to support the approval process. The accelerated communication with the FDA potentially allows, TLD-1433, in combination with the TLC-3200 medical laser system ("TLC-3200"), to be the first intravesical patient-specific Ruthenium-based PDC for the treatment of patients with BCG-Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumours. FTD can lead to an Accelerated Approval and Priority Review, if certain criteria are met, which the FDA has previously defined to the Company to represent approximately 20 to 25 patients enrolled and treated, who demonstrate significant safety and efficacy clinical outcomes.


Theralase Technology Demonstrates High Kill Rate of Coronavirus (BSL-2)


TORONTO, ON / ACCESSWIRE / November 13, 2020 / Theralase® Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that its PDC technology has demonstrated a high kill rate in a preclinical analysis of coronavirus, Biological Safety Level ("BSL-2").

Theralase previously reported that the Company's PDC technology was effective in the destruction of Influenza H1N1 and Zika viruses at low nanomolar concentrations. These studies were expanded to include coronavirus (BSL-2). As a note, COVID-19 is caused by coronavirus (BSL-3), not coronavirus (BSL-2). An assay was established to measure coronavirus destruction and using this new assay the Theralase® PDC technology was able to destroy coronavirus (BSL-2) with drug doses 5 times lower than what was used to kill Influenza H1N1 and Zika viruses. These drug doses demonstrated a 99.995% destruction rate of the BSL-2 coronavirus and are significantly lower than those used by the Company to treat cancers; hence safe for human use. All coronaviruses are considered similar in their structure and these new results strongly suggest that Theralase®'s PDC will be highly effective against the SARS-CoV-2 (coronavirus (BSL-3)) virus responsible for COVID-19.

Dr. Kevin Coombs, Ph.D., Professor, Department of Medical Microbiology, who is the principal investigator for the Theralase® PDC destruction of coronavirus (BSL-2) stated "The Theralase® compound is extremely effective in the destruction of this virus. I strongly believe that it will be equally effective against the SARS-CoV-2 (coronavirus (BSL-3)), responsible for the current COVID-19 pandemic. This lays the ground work for an effective COVID-19 vaccine using Theralase®'s patented PDC technology. Further studies are underway to determine the Mechanism Of Action ("MOA"). I look forward to continue working with Dr. Arkady Mandel and the Theralase team in the development of this exciting technology".

Dr. Arkady Mandel, M.D. Ph.D., DSc Chief Scientific Officer, Theralase Technologies Inc. stated, "We are excited that the two stages of our research, and development of a COVID-19 vaccine have been successful; specifically: the destruction of lipid enveloped Influenza H1N1 and Zika viruses followed by the destruction of the coronavirus (BSL-2) virus with Theralase®'s patented PDC. We look forward to expanding this research and development to SARS-CoV-2 (coronavirus (BSL-3)), responsible for the current COVID-19 pandemic, in the development of a safe and effective vaccine in the not too distant future."

In August 2020, Theralase® executed a Sponsored Research Agreement ("SRA") with the University of Manitoba ("UM") Medical Microbiology department to commence development of a coronavirus vaccine utilizing Theralase's patented and proprietary PDCs specifically TLD-1433. Currently the UM research is completing the preclinical (in-vitro) stage. Theralase® plans to commence an in-vivo small animal study later this year at another facility equipped to handle SARS-CoV-2 viruses and if successful commence human clinical studies in 2021, subject to suitable financing.

The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 Coronavirus.