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2) Break Through Designation Update. 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 CSS’s availability to complete all required assessments and biostatistical review and analysis.
3) COVID-19 Pandemic Update. In the ACT division, the Company continues to experience delays in patient enrollment and treatment rates in Study II due to the ongoing COVID-19 pandemic; however, these rates have improved as Canada and the US commence their recovery from the business and economic impacts of the COVID-19 pandemic.
4) Clinical study site status and update. To date, Study II has provided the primary study treatment for 51 patients (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose) for a total of 54 patients.
An analysis of Evaluable Patients (defined as patients who have been evaluated by the principal investigator and thus excludes data pending), in Study II provides the following interim analysis (including three patients from the Phase Ib NMIBC Clinical Study treated at the Therapeutic Dose):
| | Achieved Primary
Objective | Achieved Secondary
Objective | Achieved Tertiary
Objective |
| Assessment | # | % | # | % | # | % |
| Complete Response (“CR”) | 26 | 60% | 8 | 28% | 43 | 100% |
| Indeterminate Response (“IR”) | 7 | 16% | 3 | 10% | 43 | 100% |
| Total Response (“CR + IR”) | 33 | 77% | 11 | 38% | 43 | 100% |
| Evaluable Patients | 43 | 29 | 43 |
Note: The Primary Objective CR is determined at any point in time (defined above under Study II Objectives). CR was achieved as follows: 23 patients at 90 days, 1 patient at 180 days and 2 patients at 270 days.
Note: Indeterminate Response (“IR”), previously referred to as Partial Response, is defined as patients assessed with negative cystoscopy and suspicious or positive urine cytology.
| Assessment | 90 Day | 180 Day | 270 Day | 360 Day | 450 Day |
| Complete Response (“CR”) | 53% | 45% | 41% | 29% | 28% |
| Indeterminate Response (“IR”) | 14% | 24% | 19% | 15% | 10% |
| Total Response (“CR + IR”) | 67% | 69% | 60% | 44% | 38% |
| Evaluable Patients | 43 | 38 | 37 | 34 | 29 |
The clinical data to date demonstrates a strong initial CR (53%) and a strong duration of that response for 450 days (28%).
In accordance with the FDA’s 2018 guidelines to industry, the patients who have achieved an Indeterminate Response (“IR”) are being further assessed via Computerized Tomography (“CT”) scan and/or biopsy of the prostatic urethra to determine if upper tract Urothelial Cell Carcinoma (“UCC”) or prostatic urethra UCC can be detected to allow these patients to be re-categorized as CR.
Note: The current interim data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, has not been formally reviewed by Health Canada and/or the FDA, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with significant data still pending.
5) Additional cancer indications. The Company has demonstrated significant anti-cancer efficacy of Rutherrin®, when activated by laser light or radiation treatment across numerous preclinical models; including: Glio Blastoma Multiforme (“GBM”) and Non-Small Cell Lung Cancer (“NSCLC”). The Company has commenced Non - Good Laboratory Practices (“GLP”) toxicology studies with Rutherrin® in animals to help determine the maximum recommended human dose of the drug, when administered systemically into the human body, via intravenous injections. Theralase plans to commence GLP toxicology studies in animals in 4Q2022.
6) COVID-19 Research Update. In February 2022 Theralase® reported that Public Health Agency of Canada had demonstrated that light-activated TLD-1433, was effective in rapidly inactivating the SARS-CoV-2 virus by up to 99.99%, compared to control in an in vitro study. Further research is required to confirm these findings.
In July 2022, Theralase® executed a Testing and Technical Services Agreement (“TTSA”) with the National Research Council of Canada (“NRC”) to produce inactivated SARS-CoV-2 virus using Theralase®’s patented PDC and proprietary TLC-3000B medical laser system technology. This inactivated virus will be used to create a vaccine to vaccinate animals to determine the immunogenicity effects of the TLD-1433 SARS-CoV-2 (COVID-19) vaccine and assess its efficacy in protecting the animals from contracting SARS-CoV-2 during SARS-CoV-2 challenge.
Theralase® is currently designing and developing a new proprietary light activation platform; specifically, the TLC-3000B, to inactivate the virus and create the fundamental building blocks of a COVID-19 vaccine. The TLC-3000B is expected to be completed for use by PHAC and NRC in 1Q2023.
The above results and completion of the TLC-3000B will lay the groundwork for the next phase of the CRA and TTSA, which is evaluating the Theralase® COVID-19 vaccine in the ability to prevent animals from contracting COVID-19, at two world class laboratories, when exposed to the virus, which is expected to commence in 1Q2023 and be completed by 1Q2024.
Theralase Releases Q322 Interi - GuruFocus.com