Rutherrin: First batch already produced Supporting the claim that a batch of Rutherrin has already been manuactured (with Alphora (EuroFins)) ... Impossible that they mention plans for Rutherrin without having a first batch of Rutherrin in hands. Manufacturing a drug doesn't happen overnight.
Excerpt from the MD&A of 08/2021
https://theralase.com/wp-content/uploads/2021/08/MDA-Q221-Final3.pdf
Additional Oncology Targets:
Theralase® has diligently pursued the research and development of its Intellectual Property (“IP”) platform for PDCs, through scientific and preclinical research 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 pre-clinically 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 systemic treatment of recurrent, deep seated and/or progressive cancers. The Company continues to conduct extensive scientific and preclinical research towards new oncology indications and has developed significant expertise and IP assets regarding its patented PDCs, in pursuit of this goal.
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, planned for 2022, to allow localization to various cancer cells, including GBM and NSCLC and then activate Rutherrin® with radiation to safely and effectively, destroy 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.
The Company has demonstrated a significant anti-cancer efficacy of Rutherrin®, when activated by laser light or radiation treatment across, numerous preclinical in-vitro (cell lines) and in-vivo (animal) models focused primarily on GBM and NSCLC.
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 ‘tumour’s damage zone’ and the effectiveness of Theralase®’s Anti-Cancer Therapy (“ACT”) beyond the reach of light in the body