Humanigen Inc (HGENQ)

[cowtown jay]

The NIH Covid-19 Treatment Guidelines STILL find that there is insufficient evidence, "...to recommend either for or against the use of GM-CSF inhibitors for the treatment of hospitalized patients with COVID-19." This, despite that they recognize, "Data from a double-blind randomized controlled trial of lenzilumab did show a significant improvement in the primary endpoint of ventilator-free survival through Day 28 among those who received the GM-CSF inhibitor."

https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/gm-csf-inhibitors/

Further, the guidance panel recognized that the LIVE-AIR study population, "...primarily included patients on room air or low-flow oxygen..."

This was clearly stated in our trial inclusion criteria.

Inclusion Criteria: SpO2 ≤ 94% on room air...

https://clinicaltrials.gov/ct2/show/NCT04351152?term=lenzilumab&draw=2&rank=3

But the ACTIV-5 trial excluded patients on room air. Why, when they knew LIVE-AIR primarily included patients on room air?

Inclusion Criteria #6: requiring, just prior to randomization, supplemental oxygen

https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4

Our peer review reconfirmed that the LIVE-AIR trial included patients on room air.

Participants: Patients must have been hospitalised with a clinical ordinal score of 4 or 5 (oxygen saturation [SpO2] ≤94% on room air or in need of supplemental oxygen in the form of low-flow oxygen, or both;

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext

But the ACTIV-5 trial excluded patients on room air. Why, when they knew LIVE-AIR primarily included patients on room air?

The company did a peer-reviewed post hoc study on using CRP as a biomarker to identify the patients that would best respond to lenz.

Participants Hospitalised COVID-19 participants
(N=520) with SpO2 ≤94% on room air...

https://thorax.bmj.com/content/thoraxjnl/early/2022/07/05/thoraxjnl-2022-218744.full.pdf

But the ACTIV-5 trial excluded patients on room air. Why, when they knew LIVE-AIR primarily included patients on room air?

NIAID sponsored a trial on our co-therapy, remdesivir. The ACTT trial included patients with:

SpO2 < / = 94% on room air

https://clinicaltrials.gov/ct2/show/NCT04280705

But the ACTIV-5 trial excluded patients on room air. Why, when they knew ACTT included patients on room air?

This is sabotage, pure and simple. Both the NIH and NIAID are on the record with acknowledging that room air patients were included, even primarily included in all previous trials. The IG, or the company, needs to refer these findings to the FBI for prosecution.