Hide Ya Wives, Hide Ya Kids: Worldwide Coronavirus Pandemic!

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CUOMO: WESTCHESTER CO HAS 57 INFECTIONS, NEW YORK CITY HAS 11

CUOMO: EMERGENCY DECLARATION ISSUES FOR NEW YORK STATE

*CUOMO SAYS FEDERAL CDC WAS CAUGHT `FLATFOOTED' BY OUTBREAK
*CUOMO SAYS CDC IS `A BOTTLENECK' FOR COMPLETING VIRUS TESTS

TRUMP to CDC....DON'T TEST, DON'T TELL!!!!





 
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COVID-19 DRUG TREATMENT PIPELINE...

www.lifesciadvisors.com

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Introduction The 2019 Novel Coronavirus Disease (COVID-19) epidemic has roiled equity markets as recent headlines highlight disease spread outside of the initi
www.lifesciadvisors.com www.lifesciadvisors.com

Treatments in Development
More than 80 clinical trials have been reported for potential COVID-19 treatments ranging from traditional Chinese herbal medicine to complex biologics highlighting the potential to rapidly mobilize scientific efforts to address emergent threats. (8) We believe molecularly targeted antiviral therapies, genetically defined vaccines and engineered monoclonal antibodies offer the strongest scientific rationale of all the approaches proposed. Below we summarize some of the most advanced efforts from US listed companies.

Clinical Programs
Gilead Sciences (GILD) – Remdesivir
Gilead’s remdesivir is a molecularly targeted antiviral therapy designed to incorporate into nascent viral RNA chains and inhibit viral replication. Structurally, it is a nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens including Ebola, Marburg, MERS and SARS. Remdesivir was previously studied in Phase 1 / 2 trials in healthy volunteers and in people with Ebola virus infection which enabled rapid advancement to Phase 3 clinical testing for COVID-19. There are multiple nucleoside analogs approved for other viral infections thereby validating the potential of this approach, but remdesivir was previously evaluated in a late stage Ebola trial with mixed results. (9) There are five ongoing clinical trials of remdesivir for COVID-19. The first two are being conducted independently by researchers at the China-Japan Friendship Hospital in Hubei, China where GILD is providing donated drug. Results are expected in April. In the US, the National Institute of Allergy and Infectious Diseases (NIAID) is conducting an investigational trial and Gilead is sponsoring two Phase 3 trials in COVID-19 patients expected to start in March. Data from these latter trials will likely take several months or longer. A positive result in these trials would enable remdesivir to be the first therapeutic agent approved for the treatment of COVID-19.

Moderna (MRNA) – mRNA-1273
Moderna’s mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for the Spike (S) protein, which is necessary for membrane fusion and host cell infection. Moderna had previously used similar methodology to produce six other vaccines for separate infectious diseases that have completed phase 1 clinical testing showing safety and induction of an immune response to the target antigen. The most advanced candidate is now heading into a Phase 2 trial, but there are no mRNA vaccines yet approved. Moderna announced shipping the initial drug product to start the Phase 1 trial of mRNA-1273 on February 24, 2020. It is expected that it will take a couple of months to complete the Phase 1 trial of mRNA-1273 to evaluate initial safety and immunogenicity, which would then be followed by larger phase 2 / 3 trials evaluating actual protection from infection. The latter may take many months to a year realistically pushing out the earliest potential date for vaccine availability to late 2021 or 2022.

Preclinical Programs
Regeneron (REGN)
Regeneron’s is using its proprietary VelociSuite® technologies – including the VelocImmune® platform which uses a unique genetically-engineered mouse with a humanized immune system that can be challenged with all or parts of a virus of interest – to facilitate swift identification, preclinical validation and development of promising antibody candidates against SARS-CoV-2. The company previously used a similar approach to identify its REGN-EB3 antibody candidate for the treatment of Ebola in ~6 months. REGN-EB3 was later advanced into clinical development where it showed a significant reduction in death related to Ebola infection vs a comparator group thus validating the approach. (9)

Vir Biotechnology (VIR)
Collaborating with WuXi Biologics on a preclinical program to identify rare antibodies from COVID-19 survivors that may offer treatment or prevention of SARS-CoV-2 infection via direct pathogen neutralization and immune system stimulation. The company announced they haveidentified a few preclinical candidates that bind to SARSCoV-2, but may be many months to a year or longer away from completing the optimization and manufacturing work required to begin clinical testing. Vir is also collaborating with Alnylam Pharmaceuticals on the development of RNAi therapeutics targeting highly conserved regions of SARS-CoV-2. The program will utilize Alnylam’s recent advances in lung delivery of novel conjugates of siRNA, the molecules that mediate RNAi. It may be many months to a year or longer away from completing the optimization and manufacturing work required to begin clinical testing.

Novavax (NVAX)
Novavax’s COVID-19 vaccine candidates use its proprietary recombinant protein nanoparticle technology platform to produce protein antigens derived from the coronavirus spike (S) protein, and combines them with their Matrix-M™ adjuvant to enhance immune responses. The Company is evaluating multiple nanoparticle vaccine candidates in preclinical animal models to identify an optimal candidate for human testing, which is expected to begin by the end of spring 2020. Novavax previously used a similar approach to produce two separate infectious disease vaccines that were shown to be safe and able to induce an immune response in Phase 1 trials and are now in Phase 3 testing. It is expected that it will take several months to complete the Phase 1 trial of the COVID19 candidate to evaluate initial safety and immunogenicity, which would then be followed by larger phase 2 / 3 trials evaluating actual protection from infection. The latter may take many months to a year realistically pushing out the earliest potential date for vaccine availability to late 2021 or 2022.

Inovio Pharmaceuticals (INO)
Inovio is collaborating with Beijing Advaccine Biotechnology Co. to advance the development in China of INO4800, Inovio’s vaccine against the recently emerged SARS-CoV-2. The vaccine candidate will be designed to deliver DNA to induce an immune response. The program is in early preclinical development and manufacturing of a candidate has not yet begun. It may be months to a year or longer before this vaccine candidate enters clinical trials.

Altimmune (ALT)
Altimmune is working on a COVID-19 vaccine using it’s technology platform designed to provide systemic immunity following a single intranasal dose. The design and synthesis of the vaccine has been completed and the program is now advancing toward animal testing and manufacturing. It may be many months to a year or longer away from completing the optimization and manufacturing work required to begin clinical testing.

Dynavax (DVAX)
Collaborating with the University of Queensland as part of a Coalition for Epidemic Preparedness (CEPI) to develop a vaccine for COVID-19. Dynavax is providing technical expertise and the Company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support this initiative. CpG 1018 was designed to increase vaccine immune response and is the adjuvant used in HEPLISAV-B®, an FDA approved adult hepatitis B vaccine. The program is at an early preclinical stage and it may be many months to a year or longer away from completing the optimization and manufacturing work required to begin clinical testing.
 
GILEAD'S REMDESIVIR SHOWING GREAT RESULTS AGAINST COVID-19


Given the radiographic findings, the decision to administer oxygen supplementation, the patient’s ongoing fevers, the persistent positive 2019-nCoV RNA at multiple sites, and published reports of the development of severe pneumonia3,4 at a period consistent with the development of radiographic pneumonia in this patient, clinicians pursued compassionate use of an investigational antiviral therapy. Treatment with intravenous remdesivir (a novel nucleotide analogue prodrug in development10,11) was initiated on the evening of day 7, and no adverse events were observed in association with the infusion. Vancomycin was discontinued on the evening of day 7, and cefepime was discontinued on the following day, after serial negative procalcitonin levels and negative nasal PCR testing for methicillin-resistant Staphylococcus aureus.

On hospital day 8 (illness day 12), the patient’s clinical condition improved.


www.tellerreport.com

Bordeaux patient with coronavirus treated with remdesivir | tellerreport.com

This 48-year-old Bordeaux resident of Chinese origin left the Bordeaux University Hospital on Thursday morning in good health, but will undergo psychological counseling in particular
www.tellerreport.com www.tellerreport.com

What treatments has he received?
He received a specific treatment, the target of which is the virus itself, "in a context where there is no approved treatment for this coronavirus yet", reminded Professor Denis Malvy. This treatment administered to the Bordeaux patient, "an antiviral which acts directly on the virus to prevent its multiplication" is a small molecule "which diffuses perfectly into the lungs, the target organ of the disease. "This product, which is called remdesivir," is given intravenously for ten days. "Today he is the" most convincing promising candidate for an evaluation in the context of this disease "assures Professor Malvy. The choice of this drug was made "in consultation with the WHO" (World Health Organization) and will be the subject of a comparative therapeutic trial in China.



www.corriere.it

Guariti i tre pazienti a Roma: il farmaco contro l’Ebola fa sperare

Prodotto in Usa Per l’Oms il remdesivir è «l’unico antivirale che fa riscontrare una reale efficacia»: è stato utilizzato anche nei tre pazienti curati a Roma
www.corriere.it www.corriere.it

Rome Doctors' confidence in the experimental drug indicated by the World Health Organization in the guidelines on therapies to be administered to patients with Covid-19 increases. It is remdesivir , an antiviral produced by the American company Gilead Sciences, studied for the Ebola virus but which also seems to work against the new coronavirus .
"It could be the solution," said WHO head of mission in China, Bruce Aylward. The results of the first human tests, conducted in recent weeks in Wuhan hospital on serious and moderate-severity patients, will be announced in April. The clinical trialhad been accelerated precisely in the hope that the drug, tested only on animals, also active against coronaviruses of similar syndromes with severe pneumonia (SARS and MERS) could constitute therapeutic aid in an emergency situation together with a combination of specific antivirals against the 'HIV, the AIDS virus.
 
Cruise ships need to be docked indefinitely! I don’t care if I had sunk my life savings into the “cruise of a lifetime” and couldn’t get a refund. I would not be boarding that ship. People ignoring all the warning signs acting like they got nothing to lose...
 
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