For CYDY, consider il6 inhibitor Tocilizumab as a significant hurdle.
Its an approved drug, currently being used off label for Covid, to address the cytokine storm.
https://blogs.sciencemag.org/pipeline/archives/2020/06/03/remdesivir-update
https://www.medrxiv.org/content/10.1101/2020.05.29.20117358v1
- phase 3 trial of 400+ patients just finished enrollment
- will very likely show a clinical benefit
- will be trialed (phase 3) with Remdesivir, results should be available in the fall
this is what CYDY is up against. It will need to be more efficacious to compete, and the current small trials they as running simply won’t support that, IMO.
Drug: Tocilizumab
Medication class: Interleukin-6 (IL-6) receptor antagonist
Developer: Roche (as Actemra)
Approved US Indications: Tocilizumab is indicated for to treat moderately to severely active rheumatoid arthritis in adults where one or more DMARDs have provided adequate response; to treat giant cell arteritis in adults; to treat active polyarticular juvenile idiopathic arthritis (JIA) in patients age 2 years or older; to treat systemic JIA in patients age 2 years and older; and to treat CRS in patients age 2 years or older who have severe or life-threatening CRS induced by chimeric antigen receptor T-cell (CAR-T) treatment.
Rationale: Research from China has shown tocilizumab may be an effective treatment for patients with severe cases of COVID-19.
Trials: Roche is launching a randomized, controlled Phase 3 trial (COVACTA) to evaluate tocilizumab’s effectiveness in severe COVID-19 cases. The Hôpitaux de Paris is also evaluating 228 participants with COVID-19 associated pneumonia in a randomized parallel-assignment trial where patients receive tocilizumab 8mg/kg D1 or standard of care (NCT04331808).
Outcomes: Preliminary results from CORIMUNO-19 of 129 patients randomized to tocilizumab or placebo showed the drug “improves significantly clinical outcomes” of pneumonia associated with COVID-19, according to a press release. In Italy, 65 patients in the COVID-BioB Study who received tocilizumab instead of standard of care had improved clinical outcomes (69% vs. 61%; P = .61) and reduced mortality (15% vs. 33%; P = .15), but neither result was statistically significant.
Status: COVACTA is expected to begin in early April.
Agree I do not think from what I can see that there is a conspiracy to deny leronlimab approval but rather the usual FDA process. But doesn't seem so far that Tocilizumab is a favorite over leronlimab either. Perhaps it becomes part of a cocktail.
Hope that all the the enthusiasm from CYDY staff isn't a mass delusion but they seemed convinced they have the answer for covid and cancer as well.