Perspectives; Thoughts; Comments; Opinions; Discussions

Posts tagged ‘Bahrain’

Media Blackout: Nasal Spray that is 99% Effective Against COVID-19 in its Phase 3 Clinical Trial – Now Approved in India, Israel, Bahrain, Indonesia & Thailand


Reported By Jim Hoft | Published February 25, 2022

Read more at https://www.thegatewaypundit.com/2022/02/media-blackout-nasal-spray-99-effective-covid-19-phase-3-clinical-trial-now-approved-india-israel-bahrain-indonesia-thailand/

The Canadian pharmaceutical company SaNOtize Research & Development Corp., (SaNOtize), and Glenmark Pharmaceuticals Limited (Glenmark), announced earlier this month the successful outcomes of a nasal spray in its Phase 3 clinical trials and now approved by India’s drug regulator as a treatment for adult patients with COVID-19 who have a risk of progression of the disease. TrialSite is the first to report on this.

“The study confirmed that SaNOtize’s Nitric Oxide Nasal Spray (NONS) represents a safe and effective antiviral treatment that shortens the course of COVID-19, and could prevent the transmission of COVID-19,” according to their news release.

The SaNOtize Nitric Oxide Nasal Spray (NONS) is designed to kill the Covid-19 virus in the upper airways, preventing it from incubating and spreading to the lungs. It contained anti-microbial properties with a direct virucidal effect on Covid-19.

Read their news release published at Business Wire and below:

In a randomized, double-blind, placebo-controlled, parallel-arm study at 20 clinical sites across India that evaluated 306 patients, NONS reduced the SARS-CoV-2 log viral load in COVID-19 patients by more than 94% within 24 hours of treatment, and by more than 99% in 48 hours as compared to saline control.

Treatment also demonstrated, in the high-risk group (n=218), a statistically significant greater proportion of patients who achieved a combination of clinical and virological cure, based on the World Health Organization (WHO) Progression Scale. Moreover, the median time to negative PCR, in this group, was 4 days in the treatment group compared with 8 days in the control. Test subjects included patients infected with different variants, likely including Delta and Omicron. There were no significant adverse health events recorded in the Phase 3 trial, or in over 500 subjects treated so far with NONS in clinical trials.

The reduction in log viral load corroborates the reduction of viral load in the UK Phase 2 trials (a reduction of 95% in 24 hours and 99% in 72 hours), conducted in March 2021 by Ashford and St Peter’s Hospitals NHS Foundation Trust, and Berkshire and Surrey Pathology Services, and published in the Journal of Infection in August 2021.

“These results definitively substantiate the safety and efficacy of NONS in the fight against COVID-19,” said Dr. Gilly Regev, SaNOtize Co-Founder and CEO. “We are thrilled to be able to provide COVID patients with an affordable product that has been shown to deliver a faster cure. And with the proven safety profile of NONS, we look forward to this becoming the first line of treatment and potentially defense for COVID infection worldwide.”

The SaNOtize treatment is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nanomolecule produced by the human body with proven anti-microbial properties shown to have a direct effect on SARS-CoV-2, the virus that causes COVID-19. The pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. The NO molecule released from NONS is identical to the one delivered in its gaseous form to treat persistent pulmonary hypertension, or Blue Baby Syndrome, in newborn babies.

With the receipt of manufacturing and marketing approval from India’s drug regulator, SaNOtize’s strategic partner, Glenmark, will launch NONS commercially in India under the brand name FabiSpray®. The approval is for the treatment of adult patients with COVID-19 who have a risk of progression of the disease, which includes either persons over the age of 45, non-vaccinated people and/or those with comorbidities. Glenmark entered into an exclusive long-term strategic partnership with SaNOtize in August 2021 to manufacture, market and distribute NONS for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste, and Vietnam.

NONS has a marketing authorization as a Class I Medical Device in the EU. NONS is also approved and being sold in Israel, Thailand, Indonesia, and Bahrain, under the name enovid or VirX.

“As viral load is an important determinant of disease severity and transmission of COVID-19 infection, demonstration of reduction in the viral load is expected to have significant clinical consequences from a patient and community perspective,” said Dr. Monika Tandon, Senior Vice President and Head – Clinical Development, Global Specialty/Branded Portfolio for Glenmark. “In the current scenario, with new emerging variants exhibiting high transmissibility, this novel product provides a useful option in the world’s fight against COVID-19.”

Glenmark will submit the clinical trial data for publication in a peer-reviewed journal in order to share its findings.

Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials – Details

  • Patients in the Glenmark Phase 3 clinical trial in India self-administered a dose of 2 sprays per nostril, six times a day for a seven-day treatment period, along with standard supportive care.
  • The primary and secondary outcome measures demonstrated the efficacy and safety of the NONS treatment arm over the control arm, which was administered normal saline nasal spray as placebo in double-blind manner.
  • The trial also included a subgroup analysis for patients with a high risk of disease progression, including either non-vaccinated patients, patients in middle- and older-age groups, and/or patients with co-morbidities.
  • Reduction in log viral load in the NONS group was statistically significant and superior to the control group in the full population and high-risk population (p < 0.05). Similar results were seen in the un-vaccinated group. The primary endpoint was achieved and confirmed in all analyses.
  • Significantly higher proportion of patients became negative on the RT-PCR test in the NONS group as compared to the placebo group. The time to virological cure was four days in the NONS group and eight days in the placebo group (p < 0.05).
  • A significantly higher proportion of patients demonstrated a 2-point clinical status improvement on the WHO Progression Scale, the most clinically validated point system used in clinical trials, in the NONS group as compared to the placebo group in the high-risk group (p < 0.05).
  • Data suggests role of NONS in prevention of COVID-19, which is consistent with a faster viral reduction.
  • NONS was safe and well tolerated by all patients who were part of the clinical trial. There were no reports of moderate or severe or serious adverse events or death in the study. An independent Data and Safety Monitoring Board (DSMB) concluded that NONS was safe in COVID-19 patients.

“NONS destroys the virus, blocks entry into the nasal cavity and halts replication of the virus, which rapidly reduces viral load. This is important because viral load has been linked to infectivity, poor health outcomes and complications from Long COVID,” said Dr. Chris Miller, Chief Science Officer and co-founder of SaNOtize. “Amid evidence of waning efficacy for some vaccines and higher breakthrough rates, there is currently a lack of an antiviral therapy that is effective against COVID-19 and its variants that can be made widely and affordably available to the public. This is what makes NONS a critical weapon in ending the pandemic and preventing future outbreaks.”

Jim Hoft

Jim Hoft is the founder and editor of The Gateway Pundit, one of the top conservative news outlets in America. Jim was awarded the Reed Irvine Accuracy in Media Award in 2013 and is the proud recipient of the Breitbart Award for Excellence in Online Journalism from the Americans for Prosperity Foundation in May 2016.

Exclusive – Pompeo on Trump’s Peace Push: Deals ‘Are All Connected’ to Trump’s ‘Strategy’ Recognizing Iran as ‘Primary Operator for Instability’


Reported by MATTHEW BOYLE | Nicosia, Cyprus

URL of the originating web site: https://www.breitbart.com/middle-east/2020/09/15/exclusive-pompeo-on-trumps-peace-push-deals-are-all-connected-to-trumps-strategy-recognizing-iran-as-primary-operator-for-inst/

Mike Pompeo, Matt Boyle / Courtesy State Department

Pompeo’s interview came late Saturday night aboard the U.S. Air Force jet transporting him and the U.S. delegation after he met with the president of the Republic of Cyprus, Nicos Anastasiades, whom he visited here after earlier in the day attending the opening of intra-Afghan peace talks in Doha, Qatar. As the jet touched down in Doha late Friday night the previous evening, the deal being rolled out this week between Bahrain and Israel to normalize relations was announced. Previously, the United Arab Emirates (UAE) and Israel announced they were normalizing relations. On Tuesday at the White House, representatives of both Bahrain and UAE are meeting with Trump in addition to Israeli officials including Prime Minister Bibi Netanyahu.

“It’s a great question. They are all connected,” Pompeo told Breitbart News when asked to connect the dots between the Afghan peace talks and these other peace deals being rolled out now. “The president laid down a strategy for how to secure America from instability and threats from the Middle East.”

Pompeo, who is at the White House with Trump and other American officials as part of the historic meetings for the peace deals on Tuesday, said that Trump’s Middle East policy strategy vision began by treating Iran as the main threat in the region.

“It began by recognizing the primary operator for instability, the Islamic Republic of Iran,” Pompeo said. “That central decision has begun to drive all of the elements of our foreign policy in the Middle East. Reduce our footprint in Afghanistan, get our young men and women home. Reduce our footprints in Iraq and Syria, be strong in terms of sanctions and place pressure on the regime, the Islamic Republic of Iran, and then lay out a strategy for Middle East peace which had multiple pieces right?”

Several of the steps that laid the groundwork for these major steps toward Middle East peace, Pompeo told Breitbart News, include recognizing Jerusalem as the capital of Israel and several other steps taken in Israel. That, he said, has lit a path forward for Arab countries in the region for a vision for peace.

“Some of this is reality: Recognize Jerusalem as the capital of Israel, acknowledge that the Golan Heights indeed is Israeli territory. We’ve also made clear that the settlements in the West Bank weren’t necessarily unlawful,” Pompeo said. “All of those things come together to place the conditions where frankly countries in the Middle East can see a path forward for how you can take down risk and grow their economies. We think about these deals between Bahrain and the Emirates as security arrangements. That’s true, but the benefits to the economies of those three countries of opening up trade will be enormous.”

Pompeo, who on Saturday in Doha met with leaders of the Afghan government and Taliban delegations at the beginning of intra-Afghan peace talks as the U.S. is as he told Breitbart News on pace for a full withdrawal of all armed forces by next spring, said the U.S. sees Afghanistan and other countries eventually reaching a place where through “economic benefits” to the region they join other Arab nations in push for peace inside their countries and with the West. He said the hope is even Iran will one day come to the table for a real deal, rather than the flawed Iran deal from former President Barack Obama’s and former Vice President Joe Biden’s administration from which Trump withdrew the United States.

“Those economic benefits are the kind of thing that we hope one day is something we can do in Afghanistan,” Pompeo said. “We’ve made progress in Iraq as well by defeating the caliphate. All of those things come together to reduce risk from the Middle East. We hope that the Iranians will come to see that there is a pathway for them as well, but until they do, the pressure campaign will continue.”

Pompeo also said that while Afghan peace is still a ways away, and that Afghanistan becoming a country like UAE or Bahrain is still even further off, there definitely are other countries in the Middle East that are likely to soon join UAE and Bahrain soon.

“Yes there are,” Pompeo said.

Asked if it is a “peace through strength” doctrine, like what former President Ronald Reagan championed, Pompeo said it is—but the focus from Trump is on “economic strength.” He added that the president is unafraid, as he has demonstrated, to use military force however to demonstrate America’s might if needed.

“It’s absolutely the model, with an emphasis on economic strength,” Pompeo said. “The thing that America does best—our creativity, our innovation, our capacity to create opportunities for good all across the world—it’s absolutely peace through strength. We’re very much focused on making sure if there’s a bad actor, if Qassem Soleimani is threatening America, President Trump will never shy away from using military force. But we’re not going to be engaged in countries doing extended policing when they don’t generate safety and security for the American people.”

This is the second piece from Pompeo’s exclusive interview with Breitbart News. More is forthcoming.

Tag Cloud

%d bloggers like this: