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Brainstem Origin of Vagus treated by ECOR - improving Respiratory Status in COVID 19. https://www.google.com/amp/s/www.technologynetworks.com/biopharma/videos/amp/teach-me-in-10-the-vagus-nerve-and-covid-19-with-dr-paul-peter-tak-338311
ECOR EUA based on beneficial effect in COVID Asthma - less due to Cytokine based inflammation than through resisting SARS2 neuroinvasion of Respiratory centers in Brainstem along Vagus Nerve.
So ECOR -Via Vagus Nerve- Reduces Cytokines and Restricts SARS2 Neuroinvasion - decreasing Brainstem signaled respiratory depression - will act synergistically to treat COVID Pneumonia/ARDS.
To Put it Succinctly, HGEN is NVAX at $4.79 - seems like yesterday NVAX and INO were struggling in single digits - HGEN is far ahead of Its competition.
That sounds wise
ECOR Targets SARS 2 Neuroinvasion And Respiratory Depression via Vagus Nerve- “Trafficking via the vagus nerve. It is well established that influenza virus (IV) infects the lungs and spreads to the brain via the retrograde axonal transport in the vagus nerve (46, 50). The vagus nerve travels through the neck and thorax to the stomach and it connects the lung to the gut and brain, also referred to as lung-gut-brain axis (51). Since the lungs represent a major reservoir of SARS-CoV-2 infection, at least in the early stages of COVID-19 disease, it is possible that SARS-CoV-2 could use the vagus nerve to enter the CNS and travel throughout the lung-gut-brain axis, potentially interfering with all of these systems at different time-points during infection. This may explain why some patients experience a combination of gastrointestinal, neurologic and lung symptoms throughout the course of infection”
https://onlinelibrary.wiley.com/doi/epdf/10.1111/ene.14442
The second Lenz extends Rem improvement over SOC in COVID Pneumonia - HGEN will mirror NVAX results - Novavax has competition ahead of it in regulatory progress - HGEN doesn’t- with backing from the NIH and a positive result, Pfizer will do a deal to boost HGEN manufacturing if they can’t settle on an all out sale - Yes north of $41 - which may be the share price upon announcement of BET results.
CMO bought 47M shares HGEN in 2018 and hasn’t sold a single share since.
https://www.secform4.com/insider-trading/1379459.htm
$41? You before me - I may hold when 11 days to discharge is reduced by 4-5. SARS2 vaccine may mirror
Flu vaccine with its 20-60% effectiveness any given year - Lenz should be needed for a long time.
Loss of Smell & Taste due to sensory Neuroinvasion via Vagus Nerve -ECOR Gammacore will treat -“In the neuronal retrograde route of CNS entry, the virus invades neurons in the periphery, such as olfactory receptor neurons, those of the trigeminal nerve that reside in the nasal cavity, or sensory fibers of the vagus nerve in the brain stem, and leverages active transport mechanisms to gain access to the CNS.“ decreased respiration in ARDS is also due to vagal delivered CNS-Brainstem spread.
http://www.ajnr.org/content/early/2020/04/30/ajnr.A6551
GM-CSF is lighter fluid - should not be used to burn out ARDS fire- why HGEN Lenz gets pneumonia patients well enough to discharge in 5 days:
“GM-CSF has been shown to be upregulated either systemically and/or in the diseased tissues of patients with autoimmune conditions (such as rheumatoid arthritis)2,26 as well as in conditions that show similarities to late-stage COVID-19, including severe acute respiratory syndrome (SARS)27, acute respiratory distress syndrome (ARDS)28, cytokine release syndrome (CRS)29, haemophagocytic lymphohistiocytosis (HLH)30, hyperinflammation associated with graft-versus-host disease (GvHD)31 and other inflammatory diseases of the lung32, heart33,34,35 and nervous system21,23,36,37. GM-CSF-producing TH cells have been identified as being involved in the pathogenesis of various immunological disorders (for example, rheumatoid arthritis26, multiple sclerosis21,22 and sepsis38), reminiscent of the pathogenic TH17 pathway known to drive disease pathology in multiple autoimmune contexts (for example, psoriasis)39. GM-CSF inhibition via neutralizing antibodies has shown beneficial effects in a diverse range of preclinical models, including those of many of the aforementioned diseases3. In humans, treatment with GM-CSF-targeting mAbs has demonstrated efficacy across multiple phase II clinical trials for rheumatoid arthritis, with some potential advantages (for example, fewer off-target effects and decreased infection susceptibility) over standard-of-care therapeutics, such as disease-modifying antirheumatic drugs, TNF-targeting agents and Janus kinase inhibitors”
https://www.nature.com/articles/s41577-020-0357-7?elqTrackId=801873428fb148a9b448f36eae558b8b
HGEN Price per Share When Fauci Is Proven Correct in his choice of Lenzilumab? $20? $40?
Why Fauci chose HGEN- “Because GM-CSF can stimulate the expression of IL-1, IL-6, TNF and other pro-inflammatory cytokines and chemokines, a GM-CSF-targeting strategy might have broader effects than other immunomodulatory approaches when one is seeking to therapeutically dampen overactive immune responses.”
https://www.nature.com/articles/s41577-020-0357-7?elqTrackId=801873428fb148a9b448f36eae558b8b
So what’s HGEN price per share when he’s proven right?
ECOR Vagal Stimulation blocks SARS 2 Route to Respiratory centers in Brainstem during ARDS- “Considering the high similarity between SARS-CoV and SARS-CoV2, it remains to make clear whether the potential invasion of SARS-CoV2 is partially responsible for the acute respiratory failure of patients with COVID-19. Awareness of this may have a guiding significance for the prevention and treatment of the SARS-CoV-2-induced respiratory failure.” In “ The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients” https://scholar.google.com.hk/scholar?hl=en&as_sdt=0%2C33&q=SARS+2+brainstem&oq=#d=gs_qabs&u=%23p%3D3-wzSQqc2MUJ
Open Label 90 patient trial almost 4 months in and nearing Sept completion - not stopped for futility - PI is President of Spanish Neuromodulatory Society-annual mtg in Sept. “This is an open label study, it is not possible to blind the participants and healthcare providers to the intervention. The total number of patients to be included in the study is 90, with 45 in each study group The protocol version is 8.0 from 07th April 2020. The recruitment began 20th April 2020 and is expected to be complete 31st July 2020. The study is registered in clinicaltrials.gov on 29th April 2020 with the identification number: NCT04368156 The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.” ECOR
Fauci changed Rem trial for EUA - Also changed Lenz P3 to match BET- please, so obvious. NAIAD is calling the shots during National Emergency.
Yes-thanks- NIAID would never have chosen Lenz for BET had the Interim futility analysis not passed without incident. The trial started in April and has 1-2 months until completion. If you listen to CEO at BET call, P3 is full steam ahead.
He sounded at BET CC like good news comes imminently. New MAYO data.
Cameron speaks the truth -I liquidated other positions and poured it into HGEN.
Yes - good move - CEO ‘s “Forward Looking Statements” must be skirting SEC rules - I couldn’t believe how accurately he touted the Comp use data - I didn’t take full advantage - well listening to BET call and hearing him preview more MAYO data while saying what a great position HGEN is in - I have now taken full advantage - plus Nasdaq Uplisting v soon. Last point - I used to be a Halozyme maven - it’s #1 analyst just showed up at HGEN BET call - Jim Birchenough Wells Fargo.
I took advantage of a Red day to add 20K HGEN - now north of 100k shares- Note Bien: that
may influence my posting )))
8 Medical Centers added to P3 including very busy LA County Medical Center - that’s an addition of at most 8 patients per center that were added to HGEN P3 - not a big change - stimulated by powering needed for clinical improvement endpoint.
Observations on 8/5 HGEN P3 update - P3 now mirroring Comp Use endpoint (how’d that work out? ) and Remdesivir
NIAID trial (hmmm maybe the 300+ 100 BET patients will form the basis of a registration application )- “not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).“ CEO has already gone on record that P3
Population is “NOT AS SICK” as the Comp use patients-YET ARDS is STILL included in secondary endpoints “Incidence of severe acute respiratory distress syndrome (ARDS) [ Time Frame: Up to 28 days ]
Duration of Intensive Care Unit (ICU) Stay [ Time Frame: Up to 28 days ]
Ventilator-free Days [ Time Frame: Up to 60 days ]”
Estimated Study Completion Not Changed - still NEXT month-clearly the interim DMC futility analysis has come and gone Nd they recommended additional powering for current endpoints. Humanigen is clearly targeting the large middle ground of COVID 19 - choosing not to compete with Generic Dexamethasone. Good move.
New attention to Gammacore and SAR-2 neiroinvasion of Brainstem via VAGUS Nerve in UK video from Technology networks just out- https://www.google.com/amp/s/www.technologynetworks.com/biopharma/videos/amp/teach-me-in-10-the-vagus-nerve-and-covid-19-with-dr-paul-peter-tak-338311 ECOR May be directly treating COVID 19 in addition to indirect cytokine reduction.
Chinese (Ling et al) Convalescent Plasma fail published in 8/4 JAMA sheds doubt on REGN Plasma therapy (contains CP) and puts more importance on NIAID HGEN-GILD BET trial.
Convalescent Plasma Fail in JAMA this week- makes HGEN - GILD NIAID BET trial even more important - also casts doubt on success of REGN Plasma Agent that contains CP.
Like Humira, Lenz drops TNF-a - and can be dosed higher than other GMCSF that do the same because it targets the GMCSF ligand and not the receptor - so, safer- no pulmonary proteinosis.
Big News Coming from Spain - Investigator Initiated trial 90 patient trial - Dr Tornero has it timed for presentation at his Spanish Neuromodulatory Meeting In September - every AM PM price drops on No news - ECOR price being pegged in low 2’s- asthma and early ARDS data so promising - if it was related to any ARDS Targeting drug, it would rise daily. ARDS EUA on Spanish data - perhaps on interim analysis.
New Mayo Data next week - I relistened to BET call - CEO promises new Comp use and “other” data soon - as he did on call just prior to release of 1st Comp Use Data - also much was made of change in primary endpoint of P3 -.i believe Dime to match BET - much as Rem primary endpoint was changed by NIAID in trial that led to EUA.
“We are in a very strong position” HGEN CEO - At BTE conf Call - he says he’s got more Comp Use data ahead of P3 data. He has been reliable with his enthusiasm in the past.
“ECOR Is Now An Attractive Investment“
https://nasdaqnewsfeed.com/2020/08/03/electrocore-inc-nasdaq-ecor-is-now-an-attractive-investment-2/
Dr Fauci - Director of NIAID - has a better understanding of HGEN Lenz and CYDY Leron than either of us - he chose to partner Remdesivir with Lenzilumab in BET trial. This is telling.
True on IL-6 - how about TNF-a ?
LTrue on IL-6 - how about TNF-a ?
Convalescent Plasma Negative in new trial published in JAMA yesterday - 8/4 page 460 - no decrease in time to improvement - why Fauci overlooked CP and REGN Plasma and chose HGEN Lenz - he has 1st looks at data.
HGEN Targets GM CSF ligand not receptor - CEO made the points they this allies safe dosing over a very large range- due to added safety over Mav and other anti receptor agents. Leronlilumab May be safe but it’s Th1 CCR5 Target is far down the Cytokine chain and not as effective as Lenzilumab - which also influences Th1 plus other Targets (IL 6 TNFa etc).
Nature on HGEN “GM-CSF administration in patients with COVID-19 may improve lung function by strengthening the alveolar wall and enhancing viral clearance, and this approach may thus provide particular benefit in early stages of COVID-19”
https://www.nature.com/articles/s41577-020-0357-7
Enhancing viral clearance is synergistic with GILD Remdesivir.
NIAID/Fauci places HGEN Lenzilumab ahead of JAK inhibitors for ARDS as well. So many therapeutics leapfrogged by inclusion in BET.
ECOR Gammacore experience-So far first patient without migraine despite a tropical storm that would usually cause severe migraine. Promising.
HGEN- If REGN was chosen for Big BET trial by NIAID the media would be all over IT- they will be when HGEN reduces hospital discharge to 4 days with Remdesivir + Lenzilumab and to 2-3 Days with ECOR Gammacore added to the two agents.