Vasoactivity

NeuroRx Announces Completion of Data Analysis in Phase 2b/3 Clinical Trial of ZYESAMI™ for the Treatment of COVID-19 Respiratory Failure

Retrieved on: 
Friday, March 26, 2021

RADNOR, Pa., March 26, 2021 /PRNewswire/ --NeuroRx, Inc. announces completion of top line data analysis of the 60-day results in its phase 2b/3 clinical trial, conducted under FDA Fast Track Designation, of ZYESAMI (aviptadil acetate) for the treatment of critically-ill patients with COVID-19 respiratory failure ( www.clinicaltrials.gov 04311697).

Key Points: 
  • RADNOR, Pa., March 26, 2021 /PRNewswire/ --NeuroRx, Inc. announces completion of top line data analysis of the 60-day results in its phase 2b/3 clinical trial, conducted under FDA Fast Track Designation, of ZYESAMI (aviptadil acetate) for the treatment of critically-ill patients with COVID-19 respiratory failure ( www.clinicaltrials.gov 04311697).
  • A conference call will be held at 8:30am EDT on Monday, March 29th with attendance from corporate leadership and lead investigators.
  • NeuroRx, Inc. has signed an agreement to merge with Big Rock Partners Acquisition Corp.
  • Details may be viewed at http://irdirect.net/filings/viewer/index/1719406/000119312521019278
    Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970.

NeuroRx Announces Dosing of First Patient with ZYESAMI™ in P2/3 Clinical Study for the Treatment of Moderate and Severe COVID-19 (AVICOVID-2)

Retrieved on: 
Friday, March 19, 2021

To date, three clinical sites from the prior study have been initiated including University of California Irvine, Providence St. Jude Medical Center (Fullerton, CA), and University of Louisville.

Key Points: 
  • To date, three clinical sites from the prior study have been initiated including University of California Irvine, Providence St. Jude Medical Center (Fullerton, CA), and University of Louisville.
  • Jonathan C. Javitt, M.D., M.P.H., CEO of NeuroRx, stated, Dosing of the first patient in this new study shortly after the last patient 60-day visit of our first study demonstrates our firms ability to deliver in this challenging environment.
  • Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr.Sami Saidin 1970, for whom ZYESAMI is named.
  • To our knowledge, other than ZYESAMI, no currently proposed treatments for COVID-19 specifically target these vulnerable Type II cells.

FDA Grants Inhaled Use IND for RLF-100 (Aviptadil) to Treat Patients With Moderate and Severe COVID-19 Aiming to Prevent Progression to Respiratory Failure

Retrieved on: 
Thursday, August 6, 2020

The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure.

Key Points: 
  • The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure.
  • The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020.
  • Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970.
  • Before this acute phase, however, there is evidence of early viral infection of the alveolar type 2 cells.

FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure

Retrieved on: 
Thursday, August 6, 2020

The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure.

Key Points: 
  • The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure.
  • The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020.
  • Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970.
  • Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses.

FDA grants inhaled use IND for RLF-100 (aviptadil) to treat patients with moderate and severe COVID-19 aiming to prevent progression to respiratory failure

Retrieved on: 
Thursday, August 6, 2020

The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure.

Key Points: 
  • The first phase will commence with patients hospitalized for severe COVID-19 who do not yet have respiratory failure.
  • The clinical trial of the inhaled formulation of RLF-100 is expected to begin on or before September 1, 2020.
  • Vasoactive Intestinal Polypeptide (VIP) was first discovered by the late Dr. Sami Said in 1970.
  • Disclaimer: This communication expressly or implicitly contains certain forward-looking statements concerning RELIEF THERAPEUTICS Holding AG, NeuroRx, Inc. and their businesses.

FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19

Retrieved on: 
Wednesday, July 29, 2020

RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) Relief and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP).

Key Points: 
  • RELIEF THERAPEUTICS Holding AG (SIX:RLF, OTC:RLFTF) Relief and its U.S. partner, NeuroRx, Inc. today announced that FDA has granted an Expanded Access Protocol for treatment of Respiratory Failure in COVID-19 with RLF-100 (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP).
  • Although the drug remains under investigation, rapid recovery from respiratory failure in COVID-19 has been seen in patients treated under FDA Emergency Use authorization.1
    The expanded access protocol may be viewed on www.clinicaltrials.gov NCT04453839.
  • Physicians who wish to enroll their patients in the protocol must submit the protocol to their local investigational review board and file FDA form 1572 with NeuroRx, Inc. Further information may be obtained from [email protected] .
  • By granting this Expanded Access protocol, FDA has made a potentially lifesaving drug immediately available to critically ill patients who have no other available treatment, said Dr. Jonathan C. Javitt, MD, MPH, NeuroRxs CEO.

2020 Market Spotlight: Erectile Dysfunction - ResearchAndMarkets.com

Retrieved on: 
Friday, March 20, 2020

The "Market Spotlight: Erectile Dysfunction" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Market Spotlight: Erectile Dysfunction" report has been added to ResearchAndMarkets.com's offering.
  • The approved drugs in the erectile dysfunction space target phosphodiesterase 5, prostaglandin E receptor 1, alpha 2 adrenergic receptor, and vasoactive intestinal peptide receptor.
  • The largest proportion of industry-sponsored drugs in active clinical development for erectile dysfunction are in Phase I, with only one drug in the NDA/BLA phase.
  • Pfizer leads industry sponsors with the highest overall number of clinical trials for erectile dysfunction, followed by GlaxoSmithKline.

RELIEF THERAPEUTICS HOLDING SA (SIX: RLF) Announces Plans to Test Aviptadil for the Treatment of COVID-induced Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Tuesday, March 17, 2020

Aviptadil is Vasoactive Intestinal Polypeptide (VIP), a naturally-occurring peptide hormone that is known to be concentrated in the lungs.

Key Points: 
  • Aviptadil is Vasoactive Intestinal Polypeptide (VIP), a naturally-occurring peptide hormone that is known to be concentrated in the lungs.
  • VIP has been shown in five species of animal models to have potent effect in models of ARDS and Acute Lung Injury.
  • Aviptadil was awarded Orphan Drug Designation in 2001 by the US FDA for treatment of Acute Respiratory Distress Syndrome and in 2005 for treatment of Pulmonary Arterial Hypertension.
  • Acute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.

Erectile Dysfunction Industry Report 2020: Epidemiology, Marketed & Pipeline Drugs, Revenue Opportunities, Clinical Trial Landscape

Retrieved on: 
Thursday, March 12, 2020

This report covers the Erectile Dysfunction market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This report covers the Erectile Dysfunction market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • The approved drugs in the erectile dysfunction space target phosphodiesterase 5, prostaglandin E receptor 1, alpha 2 adrenergic receptor, and vasoactive intestinal peptide receptor.
  • The largest proportion of industry-sponsored drugs in active clinical development for erectile dysfunction are in Phase I, with only one drug in the NDA/BLA phase.
  • Pfizer leads industry sponsors with the highest overall number of clinical trials for erectile dysfunction, followed by GlaxoSmithKline.