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Fauci’s Buying AntiGMCSF Lenzilumab + Remdesivir - you’re selling? That will go well ....
HGEN
-NIH chose it over
$REGN
$GSK
Roivant and
$CYDY
for BET trial with Remdesivir.
ECOR Investigator President of Spanish Soc. with Annual meeting 9/26. Spanish Gammacore trial- Estimated Trial Primary Completion Date :
July 31, 2020
Estimated Study Completion Date :
July 31, 2020
https://clinicaltrials.gov/ct2/show/NCT04368156?term=Gammacore+COVID+19+Spain&draw=2&rank=
“Time Frame: From randomization to hospital discharge or ICU admission, whatever occurs first, assessed up to two months “ - Started in April - longest it can go is Sept 30 but I’d expect interim data earlier -Actually I expect Final Data at the Annual Meeting of the Spanish Neuromodulation Society in Spain at the end of September.
As the Principal investigator is President of the Society.
Sept. 26, 2020 Cádiz, Spain
X Journada Científica anual del Grupo de Trabajo de Neuromodulación de la SED
Clinicaltrials.com is always somewhat behind - the 7/31 date was a target date for Completion of enrollment in the Spanish trial - not sponsored by ECOR but by the investigator. I expect results with weeks of enrollment completion. August/September should prove exciting.
Karin- thanks for the follow- I followed back -Fez
Thank you
HGEN chosen over CYDY by NIAID and Director Dr Fauci- Don’t BET against him. https://www.marketwatch.com/press-release/national-institutes-of-health-selects-humanigens-lenzilumab-for-its-covid-19-big-effect-trial-2020-07-27-1626480?mod=mw_quote_news
Fauci picked HGEN Lenzilumab over the Regeneron antibody mixture, Over Convalescent Plasma, over anti CCR5 CYDY Leronilumab, and over all other GMCSF agents from GSK, Kiniska, Izana, and Roivant- to partner with barely significant GILD Remdesivir. I suppose the NIAID Director feels the paring is most likely to be synergistic.
Fauci picks HGEN - Don’t BET against him. NIH BETs an antiviral plus an anti-Cytokine agent will be synergistic. I bet Fauci is right - again.
BET Not Priced in - HGEN + GILD- Discharge in Under 5 days likely - HGEN CMO hinted at 6-7 day discharge in Phase 3 -a bit of slippage- compare that to 11 days to decreased viral
Shedding - not necessarily discharge- in Remdesivir cohort in same patient category. The combination in NIAID
BET should beat 5 days (recall one patient hung in hospital for 19 days due to social issues) - CEO says BET choice is not priced in - I agree - added another 11K shares today.
Is it 250K or 750K outstanding HGEN?
Thanks for your analysis
“Can neuromodulation support the fight against the COVID19 pandemic? Transcutaneous non-invasive vagal nerve stimulation as a potential targeted treatment of fulminant acute respiratory distress syndrome“
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368662/
“ We draw the conclusion that vagus nerve stimulation may be a supporting treatment in the therapy continuum of COVID-19 patients by combined modulation of respiratory function as well as the neuro-immune axis.”
ECOR
ECOR Spanish COVID trial fully Should be Fully enrolled (7/31 target)
On ECOR -“A recent paper has proposed, based on two case studies, the use of nVNS to manage
respiratory symptoms in COVID-19 patients . They showed that nVNS decreased the use of
opioids and cough suppressant medication, and promoted relief from chest tightness and shortness of breath, improving lung clearance. As both taVNS and nVNS are very easy to administer and studies have shown they can increase vagus nerve activity, they both are suggested as potential techniques in the treatment of COVID-19 patients to control inflammation and decreased respiratory discomfort associated with respiratory symptoms”
In “Neuromodulation and Inflammatory Reflex: Perspectives on the Use of Non-Invasive Neuromodulation in the Management of Disorders Related to COVID-19”
https://poseidon01.ssrn.com/delivery.php?ID=798074116064001076064087078007120011061088038065086068107116100011029008100094113105106042008122106100015022110118004029125085007083095016044095023073007085001080006051093045127119029002106127030002065103065116095070088094003101090088082011097075119093&EXT=pdf
Wow thanks for the HGEN wake up call - thinking about adding - but I think I’ll wait until after the share offering.
On HGEN ?Dilution? -I’m sorry - 525M addition shares? I missed that.
ECOR “As a result, activating the anti-inflammatory reflex mechanism modulates the exaggeration of pro-inflammatory cytokine effects (Reardon 2016; Zila et al. 2017; Chu et al. 2020). Although no drug that can be clinically effective on a7nAChR with minor side effects in humans has been discovered yet, however, vagus nerve stimulation has been used for therapeutic purposes. It can improve sepsis, lung injury, rheumatoid arthritis, stroke, traumatic brain injury, obesity, diabetes, cardiovascular control, and pain management (Zila et al. 2017).
Activating the cholinergic anti-inflammatory pathway can be a therapeutic strategy, especially for respiratory diseases and their comorbidities (Yamada and Ichinose 2018). Put together, activating the vagus nerve may demonstrate positive therapeutic effects on COVID-19 symptoms through antiinflammatory mechanisms.”
https://scholar.google.com.hk/scholar?as_ylo=2020&q=vagal+stimulation+and+COVID+19&hl=en&as_sdt=0,33#d=gs_qabs&u=%23p%3DcNoIlHFn7o8J
“ECOR is trading 52.35% above (bullish) its SMA20, 93.96% above (bullish) its SMA50 and 88.65% above (bullish) its SMA200.“
https://www.google.com/amp/s/www.investmillion.com/2020/08/03/electrocore-inc-ecor-is-showing-investors-green-in-their-portfolio/%3famp
Glad you like it - my favorite HGEN related paper
You’re right - I should have put the link right after the comment on Mav targeting the GMCSF receptor
MWM - great work on HGEN- please tell Arch that I miss him too and please ask him to contact me here or at the email
I sent. Thanks!
HGEN CC Not Market Moving - but informative.
COVID ARDS and ECOR Gammacore - “VNS appears as a serious candidate for a few side effect treatment that could dampen or prevent the cytokine storm observed in COVID-19 patients with severe symptoms.” https://scholar.google.com.hk/scholar?hl=en&as_sdt=0%2C33&q=vagal+stimulation+and+COVID+19&btnG=#d=gs_qabs&u=%23p%3DolcEMIow6dEJ ECOR - noninvasive VNS
ECOR “If you have an insurance plan administered by CVS Caremark or Ascent Health Services on behalf of Express Scripts, then gammaCore is reimbursed automatically without paperwork and with copays as low as $25 and as high as $75“
https://www.migraineagain.com/gammacore-prevent-cluster-headaches/
EIGR ”Although no synthetic IFN-lambda is yet FDA-approved, preliminary results in a clinical trial in hepatitis D patients show that it has the same antiviral potency as type I IFN but is much safer and better tolerated. A study in mice found that synthetic IFN-lambda was as effective as IFN-alpha in treating influenza but didn’t have the same proinflammatory effects.”
https://www.frontiersin.org/articles/10.3389/fneur.2020.00146/full
ECOR “nVNS inhibited trigeminal nociception in two models of episodic migraine.
- The inhibitory effects of nVNS involve GABAergic and serotonergic pathways.”
https://www.frontiersin.org/articles/10.3389/fneur.2020.00146/full
All migraine sufferers experience trigeminal irritation- Gammacore relieves it -As stated above.
Cefaly failed / Gammacore succeeded in my Migraine patient during atmospheric trigger.
ECOR Gammacore - discussed with an asthmatic EMT this AM - gave him company information and prescription in order to have Gammacore on hand if symptoms emerge- given his high Risk. This device should be stockpiled on front lines.
HGEN AH - NIAD trial ?interim P3 data - Primary Completion date is next month-,wouldn’t it be helpful to
Hear how it’s progressing?
ECOR - so far so good - patient with frequent migraines triggered by rainy conditions asymptomatic after 3 days of t.i.d. Gammacore -
Insurance Coverage for ECOR Gammacore in migraine- https://scholar.google.com.hk/scholar?hl=en&as_sdt=0%2C33&q=gammacore+%24200&btnG=#d=gs_qabs&u=%23p%3Dq1fSP_2TvsQJ
So kind of you to mention- I’m here now on HGEN - So straight from the horse’s mouth- a positive word from NIAID - and we’ll all own thoroughbreds.
HGEN - “ KNSA Mavrilimumab targets the subunit a of GM-CSF receptor (Ra) which is less well expressed by effector Macrophages/monocytes than is GM-CCF itself -so $HGEN Lenzilumab is targeting a more potent ARDS & GCA stimulus & therefore should have greater effect” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5245809/ The direct neutralizer Lenzilumab was chosen by
Fauci over the indirect receptor blocker Mavrilumab. CYDY Leronlimab blocked Th1 - via C5D5- further down the cytokine chain - not a factor.
HGEN Lenzilumab directly neutralizes GMCSF- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6376281/
So, "The scientific rationale for targeting GM-CSF in patients with ARDS is gaining strength. The initial injury response or exudative phase of ARDS is characterised by release of potent proinflammatory mediators, including GM-CSF, monocyte chemoattractant protein 1 (CCL2), IL-1a, IL-8, and TNF secreted by resident alveolar macrophages, leading to recruitment of neutrophils and monocytes. Neutrophils have been strongly implicated in the development of ARDS40 by acting as primary effector cells of bystander tissue injury through release of proteinases, reactive oxygen species, and neutrophil extracellular traps; recent reports have also highlighted the role of neutrophil extracellular traps in COVID-19.41, 42 Moreover, the extent, duration, and priming status of neutrophils in alveolar airspaces are strong predictors of outcome in ARDS.25 Alveolar GM-CSF contributes to acute and persistent neutrophilic inflammation by affecting neutrophil function, including promoting upregulation of the IgA Fc receptor, formyl peptide receptor (FPR1), CD11b, and expression of the leukotriene B4 receptor; chemotaxis, phagocytosis, release of leukotriene B4 and arachidonic acid, NADPH oxidase 2 (CYBB)-mediated superoxide anion generation; and by exerting a pronounced prosurvival effect mediated by phosphoinositide 3-kinase (PI3K)-dependent inhibition of neutrophil apoptosis."
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30267-8/fulltext
ECOR for COVID 19 - "COVID-19 is a syndrome that includes more than just isolated respiratory disease, as severe acute respiratory syndrome–
coronavirus 2 (SARS-CoV2) also interacts with the cardiovascular, nervous, renal, and immune system at multiple levels,
increasing morbidity in patients with underlying cardiometabolic conditions and inducing myocardial injury or dysfunction.
Emerging evidence suggests that patients with the highest rate of morbidity and mortality following SARS-CoV2 infection have
also developed a hyperinflammatory syndrome (also termed cytokine release syndrome). We lay out the potential contribution of a dysfunction in autonomic tone to the cytokine release syndrome and related multiorgan damage in COVID-19. We hypothesize
that a cholinergic anti-inflammatory pathway could be targeted as a therapeutic avenue."
https://link.springer.com/content/pdf/10.1007/s12265-020-10031-6.pdf
double clicked.see below
Yes Home Use is Huge- I'm an MD. I wrote to ECOR and got a free Demo Unit- I plan to use in the office to educate my Migraine patients- But I've already used it at home on family with same condition - it's quick and easy- Hope it works- I'll be posting on this in the near future.
Sham Treatment for ECOR Gammacore study is the placement of the unit with conducting gel over the carotid artery pulse- the treatment site -where the vagus nerve lies- without electric stimulus.
“VNS appears as a serious candidate for a few side effect treatment that could dampen or prevent the cytokine storm observed in COVID-19 patients with severe symptoms.” https://scholar.google.com.hk/scholar?hl=en&as_sdt=0%2C33&q=vagal+stimulation+and+COVID+19&btnG=#d=gs_qabs&u=%23p%3DolcEMIow6dEJ ECOR - noninvasive VNS