From Quarterly MD&AWell the next news letter if Theralase stays to form we can expect next News Letter end of Feb , However the company has indicated new trials in new oncology targets to begin in early 2022 , I would expect that if we will recieve some form of information on this before next news letter. Further Trudeau keeps pounding out the merits of recent Throne speech and Goverment Investment in Canada made and produced vaccine . So who knows that shoe could drop any time IMHO My point is that we are in for a big first half of 2022 . 8 plus years for me here : -( very large position : -) I was reading the MD$A I am just thrilled to Know we are very close to showing the world what this company's tech is cappable of. Any lingering doubts I had are completley gone ! All i can think of are words from one of my favourite philosepher's - YABBA DABBA DOO !!!
Additional Oncology Targets: Theralase® has diligently pursued the research and development of its Intellectual Property (“IP”) platform for PDCs, through scientific and preclinical research and development to fine-tune the photophysical and photochemical properties of the PDCs, by the inventor, while demonstrating Type I (oxygen independent) and II (oxygen dependent) photoreactions and activation in hypoxia. By combining these PDCs with transferrin (human glycoprotein), as a delivery system it has been preclinically demonstrated that transferrin is able to significantly: • Increase the resistance of TLD-1433, the lead drug candidate, to photobleaching (loss of potency of the PDC over time) • Increase ROS production (ability to destroy cancer cells quickly and effectively) • Increase selective tumour uptake (destruction of cancer cells, while sparing healthy cells) through the Transferrin Receptor (“TfR”) • Increase anti-cancer efficacy (efficiency in cancer cell destruction) • Decrease systemic toxicity (damage to healthy cells and/or organs) This allows Rutherrin® (TLD-1433 + transferrin) to be a strong candidate for the systemic treatment of recurrent, deep seated and/or progressive cancers. The Company continues to conduct extensive scientific and preclinical research and development towards new oncology indications and has developed significant expertise and IP assets regarding its patented PDCs, in pursuit of this goal. Due to the limitations of using laser light to activate Rutherrin® in deep oncological targets, Theralase®’s research strongly suggests that Rutherrin® may be activated with radiation therapy, which is able to increase the ‘tumor’s damage zone’ and the effectiveness of Theralase®’s ACT therapy beyond the reach of light in the body. Radiotherapy (“RT”) is one of the primary treatment methodologies for many types of cancer, although it is currently a challenge to enhance radiation damage to tumor tissue, while reducing side effects to healthy tissue. Rutherrin® is a unique agent that offers the ability to enhance injury to tumor tissue by accelerating damage through the production of free radicals; thereby, acting as a radio enhancer. Several preclinical strategies have been investigated by Theralase’s scientists to research, develop, optimize and advance highly selective and effective radio sensitizing properties of Rutherrin®. Below, we highlight recent progress on the current research and development initiatives utilizing Rutherrin®, in several in vitro and in vivo models is reported. Rutherrin® activation via RT is preferential to light activation due to the much deeper tissue penetration of RT. 9 10 Further research and development is currently underway into the mechanisms of action of Rutherrin®, it’s multidisciplinary applications, delivery methodologies, safety and efficacy. Once Rutherrin®’s Maximum Tolerated Dose (“MTD”) and hence Human Equivalent Dose (“HED”) limits have been determined through non-Good Laboratory Practices (“GLP”) and GLP toxicology studies, Theralase® plans to inject Rutherrin® systemically into patients via a Phase Ib clinical study, to allow localization to various cancer cells, including GBM and NSCLC and then activate Rutherrin® with radiation with the intent of safely and effectively destroying the cancer of interest. Rutherrin®, if proven successful, would thus be able to “hunt” and “localize” into cancer cells and when activated by radiation “destroy” them; wherever, they may reside in the body. Additional Virus Targets* Theralase® executed a Sponsored Research Agreement (“SRA”) with the University of Manitoba (“UM”) Medical Microbiology department in 3Q2020 to commence development of a coronavirus vaccine utilizing Theralase®’s patented and proprietary PDCs. The primary objective of the SRA was to investigate the efficacy of Theralase®’s lead PDC to destroy a variety of viruses; including: H1N1 Influenza, Zika and coronaviruses 11 (Biological Safety Level (“BSL”) 2). The secondary objective was to optimize the concentration of PDC required, the activation methodology and how to potentially administer the treatment to humans to be used as a vaccine (prevention of a patient from contracting COVID-19) (BSL-3). The Company’s PDC technology was effective in the destruction of H1N1 Influenza and Zika viruses at low nanomolar concentrations and the research and development was expanded to include coronavirus (BSL-2). Note: COVID-19 is caused by coronavirus (BSL-3), not coronavirus (BSL-2). A rapid test 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 H1N1Influenza and Zika virus. These drug doses are significantly lower than those used by the Company to treat cancers and are therefore considered safe for human use. All coronaviruses are highly similar in their structure and these new results suggest that Theralase®’s proposed vaccine could be highly effective against the SARS-CoV-2 virus responsible for COVID-19. Further studies have shown that the human coronavirus (“CoV”) appears to be much more sensitive to the action of the activated Theralase® PDC vaccine, with a dose as low of 3.3 nM required to inactivate 50%, whereas; 9.2 nM was required to inactivate the same amount of H1N1 Influenza virus and 12 nM was required to inactivate the same amount of Zika virus. The amount of PDC required to inactivate 99.9% of each virus are 61 nM for CoV, 322 nM for Zika virus and 497 nM for H1N1Influenza virus, respectively; thus, the Theralase® PDC is 3 to 5 times more effective against CoV compared to the other tested viruses. The Theralase® compound is also effective without activation, but on average, its activation results in a 4.2 fold increase in Zika virus inactivation, a 12 fold increase in H1N1 Influenza inactivation and an 18.7 fold increase in CoV inactivation. In April 2021, Theralase® executed a Collaborative Research Agreement (“CRA”) with the National Microbiology Laboratory, Public Health Agency of Canada (“PHAC”) for the research and development of a 12 Canadian-based SARS-CoV-2 (“COVID-19”) vaccine. Under the terms of the agreement, Theralase® and PHAC are collaborating on the development and optimization of a COVID-19 vaccine by treating the SARS-CoV-2 virus grown on cell lines with Theralase®’s patented PDC and then light activating it with Theralase®’s proprietary TLC-3000A light technology to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. This inactivated virus could then be purified and used to inoculate naive animals, followed by challenge with the SARS-CoV-2 virus, to ascertain the efficacy of the vaccine. The project is entitled, “Photo Dynamic Compound Inactivation of SARS-CoV-2 Vaccine” and commenced in mid-April 2021. This research and development is currently ongoing and no reportable data is available at this time. Note: The Company does not claim or profess that they have the ability to treat, cure or prevent the contraction of the COVID-19 coronavirus. ACT Research Centre In April 2021, the Company launched the Theralase® Anti-Cancer Therapy (“ACT”) research center located within the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Unity Health Toronto, relocating its research team from University Health Network (“UHN”). The ACT research center is a fully equipped laboratory dedicated exclusively to Theralase® ACT research and development, as Theralase® advances towards commercialization with its lead PDC, TLD-1433, as well as its systemic and targeted formulation – Rutherrin®