Russia Is Now The First Country With An Approved COVID19 Pharmaceutical to Treat Patients

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Russia Is Now The First Country With An Approved COVID19 Pharmaceutical to Treat Patients

Kaleidoscope’s House of Broken Glass

Forget the race to the moon, now Russia is the first country to clinically approve the first pharmaceutical medication to administer to patients in the early stages of COVID19 where the cases are moderate. Coronavir (favipiravir) produced by R-Pharm Innovated Health Technolgies +7 (495) 956 79 37+7 (495) 956 79 38 | 119421, г. Москва, Ленинский проспект, д.111Б (R-Pharm’s plant in Yaroslavl). Almost 200 miles from Moscow. R-Pharm has business connections and are collaborating with one of America’s top Pharma company including AstraZeneca.

Vaccine from AstraZeneca and the University of Oxford – On July 17, 2020, R-Pharm and AstraZeneca made a statement on their cooperation in the manufacturing of a recombinant adenovirus vaccine in Russia to prevent COVID-19 infection caused by SARS-CoV-2 virus.  Within the framework of cooperation, it is scheduled to implement the manufacturing of AZD1222 vaccine, developed by the professionals from the University of Oxford, at the manufacturing facilities of R-Pharm, providing the successful clinical trials. http://www.r-pharm.com/en/press-center/news/479The interim analysis of randomized Phase III clinical trial of Coronavir (favipiravir) has been published  in the peer-reviewed scientific journal Medical Opponent No. 1 (9) from JUNE 2020;
The randomized comparative study observed that the use of Coronavir at early stage of mild to  moderate coronavirus infection  reduced number of complications requiring hospitalization;
Clinical improvement in COVID-19 positive patients taking Coronavir statistically occurs 3.5 days earlier compared to the standard of treatment (SOT).
R-Pharm
 Group has presented the interim analysis in Phase III randomized clinical trial of Coronavir (INN: favipiravir) in COVID-19. The article titled “Possibility  of Antiviral Therapy of SARS-CoV-2 Coronavirus Infection in outpatient setting” by professor T. A. Rouzhentsova and co-authors has been published in one of the leading Russian scientific journals, Medical Opponent.
Coronavir is one of the first drugs in the world that is combating the virus directly. The drug developed by R-Pharm
 Group inhibits viral RNA polymerase that is involved in replication of the virus.
The interim data based on analysis of 60 patients with mild to moderate COVID-19 demonstrated that clinical improvement according to the World Health Organization (WHO) Ordinal Scale for Clinical Improvement corresponding to positive changes or resolution of clinical symptoms occurred in Coronavir group on day 6.95 (± 4.55) vs. day 10.4 (± 5.0) in SOT group (umifenovir with interferon alfa) (p  < 0.05). Therefore, the use of Coronavir allows early clinical improvement for a mean of 3.5 days.  Besides, on day 7 of the study, clinical improvement was observed in 55% of patients receiving Coronavir while in the control group improvement was observed only in 20% of patients. Meanwhile, the extent of SARS-CoV-2 elimination from oropharynx mucous membranes that was determined by the presence of SARS-CoV-2 RNA in smears was also higher in Coronavir group: On day 5 of the therapy it was observed in 77.5% of patients in the favipiravir group vs. 55% of patients in the control group.
It shall be noted that there was no hospitalization in  Coronavir (favipiravir) arm  while 10% of the control group (with the patients getting no appropriate medical therapy had to be hospitalized due to the progression of the disease.
An equally relevant result was the demonstration of Coronavir’s favorable safety profile. Thus, the overall incidence of adverse events in the intervention group was comparable to that observed in the group of standard therapy. Specific adverse reactions included only hyperuricemia (excess of uric acid in the blood) that was asymptomatic and resolved after the completion of treatment.
Judging by the results of the clinical trials, it is possible to say, that Coronavir is among the most promising medicines, which can be used for treatment of COVID-19 infection. With financial support from the Russian Industrial Development Fund the Coronavir manufacturing facilities were established at R-Pharm’s plant in Yaroslavl.
Starting from July 6, 2020, when Coronavir received marketing authorization in Russia, more than 13 000 packs of the medicine have been delivered to various Russian hospitals, specialized in fight against COVID-19. Several hundred thousand more packs are expect to be manufactured in August to meet rising demands of the Russian healthcare system and, after that is accomplished, to help patients abroad Russia.
Professor Tatyana Rouzhentsova, the principle investigator: “One of the most important results of the study was the conclusion that the use of Coronavir in the early stages of the novel coronaviral infection helps to significantly reduce the likelihood of complications and progression of the disease in outpatients settings.”
Olga Filon, Medical Director of Drug Technology LLC: “Unlike the team behind clinical trials of two alternative favipiravir products only studied in the hospital setting, we researched Coronavir as an outpatient care in patients with mild to moderate disease. The drug showed high efficacy in terms of influencing the clinical pattern (reduced the time to improvement by 3.5 days) and the rate of virus elimination.”
Mikhail Samsonov, Chief Medical Office, R-Pharm
 Group, Candidate of Medical Sciences: “Today we are pleased to present early results of the registrational clinical study of Coronavir to medical community. Prevention of disease progression by early treatment of patients with mild to moderate symptoms will help doctors to combat this infection more efficiently.”
R-Pharm’s Global anti-COVID-19 program

R-Pharm
 Group is implementing a comprehensive program that aims to defeat COVID-19 infection. This program includes research and development of new molecules and therapy methods, reevaluation of current product portfolio, creation of a brand new Russian vaccine, and introduction of new efficient blood testing systems on the Russian market.

Artlegia (olokizumab). On June 3, 2020, the Ministry of Health of the Russian Federation included the monoclonal antibody (mAb) developed by R-Pharm
 in the guidelines for the treatment of moderate to severe COVID-19. The drug indicated to prevent cytokine storm (one of the main reasons of mortality in patients with COVID-19) was the first Russian original biologic  recommended by Russian MoH for the treatment of coronavirus infection. Today, Artlegia is used in the majority of subjects of the Russian Federation, is undergoing the process of clinical and regulatory evaluation in countries with high incidence of the disease such as India, Brazil, and the United States. Together with the Russian Direct Investment Fund (RDIF), R-Pharm
 is conducting negotiations on supply of Artlegia to the countries of the Middle East;
RPH-104. Аnother biotechnology product from the company’s portfolio (original RPH-104) is now being studied in clinical trials with the goal to assess its efficacy in the treatment of severe COVID-19. The medicine is able to block IL-1 inflammatory mediator protein;
RPH-137. R-Pharm
 is conducting preclinical studies of a biological molecule developed in the laboratories of the Group in Moscow and San Diego (CA, USA) and indicated to combat COVID-19 directly. The innovative drug can bind viral particles and prevent them from penetration into alveocytes;
Radotinib. On May 14, 2020, R-Pharm
 received authorization to conduct clinical studies of Radotinib to evaluate its efficacy in the treatment of patients with COVID-19. As fast as in the early stages of in vitro testing, the drug was already efficiently suppressing SARS-CoV and MERS-CoV viruses. In early 2020, a number of in vitro studies showed that Radotinib significantly inhibited the replication of SARS-CoV-2 virus 48 hours after treatment. Clinical studies in Russia have been initiated at 11 centers;
First domestic vaccine (Federal Government Budgetary Institution “National Research Center for Epidemiology and Microbiology named after the honorary academician N.F. Gamaleya” of the Ministry of Health of the Russian Federation) – On June 10, 2020, R-Pharm
 corporate group together with the Russian Private Investment Fund (RPIF) announced a joint effort to produce the first Russian vaccine with high export potential, developed at National Research Center for Epidemiology and Microbiology named after the honorary academician N.F. Gamaleya of the Ministry of Health of the Russian Federation. Upon the completion of the development the vaccine will be manufactured at the new R-Pharm
 plant in Yaroslavl, which will be opened in cooperation with RPIF;
Vaccine from AstraZeneca and the University of Oxford – On July 17, 2020, R-Pharm
 and AstraZeneca made a statement on their cooperation in the manufacturing of a recombinant adenovirus vaccine in Russia to prevent COVID-19 infection caused by SARS-CoV-2 virus.  Within the framework of cooperation, it is scheduled to implement the manufacturing of AZD1222 vaccine, developed by the professionals from the University of Oxford, at the manufacturing facilities of R-Pharm, providing the successful clinical trials. 
Test systems – On May 15, 2020, R-Pharm
 corporate group registered express test systems on the territory of the Russian Federation. These test systems are designed to diagnose IgM/IgG antibodies produced during the infection with COVID-19, by enzyme immunoassay of serum, plasma and whole human blood. Test systems were developed by Beijing Lepu Medical Technology. In early June, R-Pharm
 registered and began to deliver two more test systems to Russia – Core Technology and VivaChek Biotech (Hangzhou).
http://r-pharm.com/en/press-center/news/479

Drugs.com has the following article posted on their webpage-Link is attached at end of article

AZD1222 FDA Approval Status

https://www.drugs.com/history/azd1222.htmlRNA polymerase (purple) unwinding the DNA double helix and uses one strand (darker orange) as a template to create the single-stranded messenger RNA (green)

FDA Approved: No
Brand name: AZD1222
Generic name: SARS-CoV-2 vaccine
Previous Name: ChAdOx1 nCoV-19
Company: AstraZeneca
Treatment for: Prevention of COVID-19

AZD1222 (formerly ChAdOx1 nCoV-19) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19.

  • AZD1222 works by using a viral vector (ChAdOx1 – chimpanzee adenovirus Oxford 1) based on a weakened version of a common cold (adenovirus) virus that contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the virus if it later infects the body, protecting it against COVID-19.
  • A Phase I/II clinical trial commenced on April 23, 2020 to assess the safety, immunogenicity and efficacy of AZD1222 in 1077 healthy volunteers aged 18 to 55 years across several trial center’s in southern England. Interim results were published in The Lancet on July 20, 2020.
  • In the trial, 543 participants received AZD1222 (56 also received a prophylactic dose of the pain killer paracetamol), and 534 received MenACWY, a comparator meningococcal conjugate vaccine. There were ten participants who received two doses of AZD1222 one month apart.
    • The results confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection. Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of participants one month after vaccination and in 100% of participants who received a second dose.
    • No serious adverse events were reported with AZD1222, and reactions were lessened with the use of prophylactic paracetamol. Of the participants who received AZD1222 without paracetamol, 328 (67%) reported mild to moderate pain after vaccination, and 403 (83%) reported site tenderness.
    • Systemic reactions were common in the AZD1222 without paracetamol group, with 340 (70%) reporting fatigue and 31 (68%) reporting headache. Other reactions reported in this group include muscle aches (60%), malaise (61%), chills (56%), and feeling feverish (51%). Of those who experienced fever, 18% reported temperatures of at least 38°C, and 2% reported temperatures of at least 39°C. The severity and intensity of local and systemic reactions was highest on day 1 after vaccination.
  • Late-stage Phase II/III trials will be conducted in the UK, Brazil, South Africa and the US.

https://www.drugs.com/history/azd1222.htmlRNA polymerase (purple) unwinding the DNA double helix and uses one strand (darker orange) as a template to create the single-stranded messenger RNA (green)

The interitem clinical trials that were conducted by R-Pharm for the medication consisted of 60 patients. The FDA requires min. of 20 to 80 patients in clinical PHASE ONE. PHASE TWO consist of several hundred. PHASE THREE several thousands. 60 patients seem like a small spec in space in comparison. I’m by no means a scientist or doctor, I am a decent researcher and could have missed documentation, however from what I concluded there is not any further information pertaining to more than 60 patients during their study. What has me concerned and wanting to know more is the fact that in the joint efforts of combating Covid-19 with AstraZeneca is it went from a pharmaceutical at R Pharm to a vaccination. Which without being a doctor I can say are two entirely different scenarios.

Professor Tatyana Rouzhentsova, the principle investigator: “One of the most important results of the study was the conclusion that the use of Coronavir in the early stages of the novel coronaviral infection helps to significantly reduce the likelihood of complications and progression of the disease in outpatients’ settings.”

There is a separate guideline for EMERGENCY TRIALS. COVID-19 does fall under the category of emergency.

The emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB. The exemption, which may not be used unless all of the conditions described in 21 CFR 56.102(d) exist, allows for one emergency use of a test article without prospective IRB review Which can be found on the FDA webpage.

Don’t let the headlines be just headlines. There’s always more to the story. If you want the information it is available. You just have to the initiative to inform yourself.

Kaleidoscope Thoughts

Forget the race to the moon, now Russia is the first country to clinically approve the first pharmaceutical medication to administer to patients in the early stages of COVID19 where the cases are moderate. Coronavir (favipiravir) produced by R-Pharm Innovated Health Technolgies +7 (495) 956 79 37+7 (495) 956 79 38 | 119421, г. Москва, Ленинский проспект, д.111Б (R-Pharm’s plant in Yaroslavl). Almost 200 miles from Moscow. R-Pharm has business connections and are collaborating with one of America’s top Pharma company including AstraZeneca.

Vaccine from AstraZeneca and the University of Oxford – On July 17, 2020, R-Pharm and AstraZeneca made a statement on their cooperation in the manufacturing of a recombinant adenovirus vaccine in Russia to prevent COVID-19 infection caused by SARS-CoV-2 virus.  Within the framework of cooperation, it is scheduled to implement the manufacturing of AZD1222 vaccine, developed by the professionals from the University of Oxford, at the manufacturing facilities…

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