Theralase has not abandoned plans for an eventual GBM clinical trial: "The ACT division is in the preclinical research and development of Rutherrin® intended to be utilized as an injectable form of TLD1433, for the treatment of Glio Blastoma Multiforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”)." Theralase is shooting for Accelerated Approval in 1Q2023 "Break Through Designation Update
In 2020, the FDA granted Theralase® Fast Track Designation (“FTD”) for Study II. As a Fast Track designee, Theralase® has access to early and frequent communications with the FDA to discuss Theralase®’s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study Treatment, to be the first intravesical, patient-specific, light-activated, Ruthenium-based PDC for the treatment of patients diagnosed with BCG Unresponsive NMIBC CIS, with or without papillary Ta or T1 tumors. FTD can also lead to Break Through Designation (“BTD”), Accelerated Approval (“AA”) and/or Priority Review, if certain criteria are met, which the FDA has previously defined to the Company for BTD as a complete clinical dataset on approximately 20 to 25 patients enrolled, treated and followed-up, who demonstrate significant safety and efficacy clinical outcomes.
In 2021, Theralase® completed its first significant milestone of Study II by enrolling and treating 25 patients. The Company will compile a clinical data report for submission to the FDA in support of the grant of a BTD approval after completion of the 450 assessments for 25 patients, expected in 4Q2022, subject to the CSSs availability to complete all required assessments."
There were zero serious adverse effects related to the phase 2 treatment
"Theralase® believes all SAEs reported to date are unrelated to the Study Drug or Study Device, subject to final review and confirmation by the independent Data Safety Monitoring Board (“DSMB”)."
Clinical trials for other cancer indications, including recurrent, deep seated and/or progressive cancers ( GBM, NSCLC, colorectal cancer, esophageal cancer ) using the systemic instillation of Rutherrin and radiation activation are in the works
"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. "
Evaluation of Theralase Covid-19 vaccine in animals to be completed in 2022. Human phase 1 clinical trial in 2023?
"These results have now laid the groundwork for the next phase of the CRA, which is evaluating the Theralase® COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, when exposed to the virus, which is expected to commence in 2Q2022 and be completed by 4Q2022."