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Found this on Stanford Medicine Covid vaccine and therapeutics site.
Drug Category: Immune Modulator (Cytokines)
Intervention Targets:
Sponsors: Synairgen Research Ltd., Cadila Healthcare Limited
Countries: China, Hong Kong, Iran, Islamic Republic of, United Kingdom, Italy, France, United States, Mexico
clinical-trials.gov NCT04469491
Interestingly the title states INF- beta 1b but detail states development lead is interferon beta 1a (SYN) via inhalation/nebulization. End date March 2021.
Did a bit of cross referencing. Basically some of those listed as prophylaxis trials on racap are chemical not biological. I did, however, find some more info on MAb manufacture. Not quite convalescent plasma but see the FDA note below. Basically this would leave us with 3 (MAb, SYN and Eiger peginterferon Lamda). It would be great if anyone else had anything to add/fix/clarify.
Treatment and prevention (Biological) (1 candidate listed on EMA)
1. Regeneron/Roche (REGN/COV2) - MAb. (Scalability/SE/administration issues?)
Commercial mAb production requires more than the culturing of large batches of cells or their injection into large numbers of mice. It requires considerable preproduction effort to ensure that the cell line is stable, can produce commercially appropriate quantities of a stable antibody, and can produce an uncontaminated product. Commercial production also involves building a high-quality facility for in vivo and in vitro production and for processing of the antibody. There is a need for quality control and quality assurance departments to meet the requirements of good manufacturing practices that are required for commercial products. Product-lot testing is necessary to ensure product reproducibility. Production-process verification and documentation are necessary to protect the consumer and are required by FDA in its regulatory “Points to Consider in the Manufacture and Testing of mAb Products for Human Use” (FDA 1997).
2. fujifilm (Avigan)- chemical? X
3. SNG (prophylaxis indicated in most phase 3 trial as per Oxford and also ticked in phase 2 trials).
4. Romark (nitazoximide) (initiated COVID prophylaxis phase 3 trial April 20. Phase 3 treatment trial initiated August 20). Chemical. X
5. Eiger (PEG interferon Lamda) - treatment only Phase 2 complete? 15/10/20 results. Mild disease, SubQ.
6. Pulmicort (PUL-042) - phase 3 recruiting in France. NCT0433105. Discounted as Chemical not biological. X
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Lovely paragraph quoting Prof Herzog:
However, I would urge caution before abandoning one of the body’s premier family of antiviral compounds, because of the design of this SOLIDARITY trial. Firstly, the route of administration might not be ideal. The interferon ß1a was mostly delivered subcutaneously, which is not the best way to deliver interferon ß1a to the lungs and is known to be less efficient than intravenous or inhaled. The latter is being trialled. Secondly, about half of the patients received corticosteroids at the same time and these are known to block interferon responses.
After having a look at the racap data, I’ve realised that Regeneron/Roche are trialling REGEN/COV 2 in SUBQ for prophylaxis and Eli Lily are trialling the MAb via IV for prophylaxis. These are both convalescent plasma derived (Biological). I just can’t see that manufacture/administration/side effects wouldn’t be an issue with these for prophylaxis. Trials due to end March 2021. SYN is just so much cleaner and scalable.
Very interested in the biological vs chemical classification of the substance. MCAs haven’t been touted as prevention as far as I’m aware and vaccines aren’t regarded as a treatment. Dex is synthetic (chemical). I’m aware that the newly knighted professor did make a comment in his lecture last night regarding prophylaxis and of course interferon is biologically derived....
This man appears to be a local GP in Lakewood California. Twitter photo obvs from 1980s and just over 1000 followers, not 100k followers. Think this may just be his opinion rather than actual direct info.
To all genuine investors, don’t get caught up in the end dates. For various reasons trials can be stopped early. In this case, where benefit was clearly evident in the initial phase 2 trial I suspect the trial may have been extended to provide FURTHER evidence of efficacy. See below re: Reasons why trials can be halted prior to expected end date. I know which I would suspect to be the case in a global pandemic....
At each interim review, the DSMC may recommend continuing the trial as originally designed, or continuing with a modification of the protocol. Alternatively, for several reasons the committee may recommend stopping the trial before the estimated sample size has been reached, or before the expected follow-up period is complete. First, it is possible that the original sample size was overestimated. Second, the new treatment may have a beneficial or a detrimental effect that is already apparent. Third, the trial may be deemed to be futile; in other words, it is unlikely that an answer to the primary question will be attained in a reasonable time, if ever. This might be due to a previously unrecognized flaw in the trial design, or to inadequate patient recruitment. Fourth, there may be external influences such as changing practice or newly learned results from other studies. Fifth, the question under study may no longer be relevant; the new treatment may even be “obsolete.”
Hi all. I’ve been watching this post for months. I’m familiar with a few regulars here by now. I’m from a medical background and I can assure you that this drug has potential for COVID and beyond. Imagine this being used prophylactically in seasonal flu, treatment of COPD and possible pulmonary fibrosis. Is it useful in pneumonia? Is it something that can be used to create a full body response to numerous other conditions? I just think the applications are huge.
Also, for those who think COVID has gone away/weakened etc well, I wish I worked where you must work.....