Hibiscus24 Jul 2020 13:18
Putting 2 and 2 together
Originally they were in talks with the FDA for a retrial of Traumakine 9th march RNS
"Faron is planning to split the clinical development of Traumakine in ARDS into two steps, commencing with INTEGRITY, a pilot randomised and placebo controlled study with approximately 60 patients. The INTEGRITY data will then serve as final adjustment for adequate statistical powering and sample size justification for the pivotal CALIBER study, subjected for FDA review. The Company expects that the sample size of the CALIBER study will not exceed 200 patients based on the post hoc analysis of the INTEREST trial data. As previously announced, the Company envisages that future Traumakine trials (including INTEGRITY and CALIBER) are likely to be funded through a third party or parties"
Then 16th june hibiscus is announced
"Today the Company announces that a third trial will investigate the potential of Faron's IV IFN beta-1a to treat COVID-19. HIBISCUS (Human Interferon Beta In Severe CoronavirUS), will be an investigator initiated study at Harvard Medical School's Beth Israel Deaconess Medical Center (BIDMC), focused on ICU patients with ARDS caused by viral infection (e.g. COVID-19, influenza). The phase II/III pivotal, randomized, placebo controlled study aims to recruit 350 patients with 1:1 randomization who will be followed for ventilation free dats (VFD) and mortality over the 28 day period post first dosing. No corticosteroid use will be accepted in the study which is expected to enroll patients over 6-8 months throughout the US with many significant hospitals participating. Commencement of the trial remains subject to finalisation of funding arrangements and regulatory approval. Further announcements will be made in due course"
Can we assume that CALIBRE trial is replaced by HIBISCUS?
In either case who will fund it?
I have a theory.. the USA are not taking part in WHO solidarity trial, with recent developments what's the chances the us goverment or a US pharma funds our trial/s over there?
Any thoughts?