Cytokine storm

Sigyn Therapeutics Featured on National Public Radio: “Addressing the Cytokine Storm”

Retrieved on: 
Monday, August 30, 2021

Founded in 1993, Tech Nation is a weekly National Public Radio program hosted by Dr. Moira Gunn.

Key Points: 
  • Founded in 1993, Tech Nation is a weekly National Public Radio program hosted by Dr. Moira Gunn.
  • During the current pandemic, the cytokine storm has been a leading cause of death in severe COVID-19 infections.
  • Sigyn Therapeutics is focused on significant unmet need in global health; the treatment of life-threatening inflammatory conditions that are precipitated by Cytokine Storm Syndrome.
  • This press release contains forward-looking statements of Sigyn Therapeutics, Inc. (Sigyn) that involve substantial risks and uncertainties.

Sigyn Therapeutics, Inc. Announces Participation in the Q3 Virtual Investor Summit

Retrieved on: 
Tuesday, August 24, 2021

To calm the Cytokine Storm, Sigyn Therapy extracts pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators from the bloodstream.

Key Points: 
  • To calm the Cytokine Storm, Sigyn Therapy extracts pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators from the bloodstream.
  • An additional study modeled the ability of Sigyn Therapy ability to address CytoVesicles that transport inflammatory cargos throughout the bloodstream.
  • The Company also conducted a first-in-mammal pilot study that demonstrated the safe administration of Sigyn Therapy during six-hour treatment exposures.
  • Virus-induced Cytokine Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19) infections.To learn more, visit www.SigynTherapeutics.com .

Sigyn Therapeutics, Inc. Announces Participation in the Q3 Virtual Investor Summit

Retrieved on: 
Tuesday, August 17, 2021

To calm the Cytokine Storm, Sigyn Therapy extracts pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators from the bloodstream.

Key Points: 
  • To calm the Cytokine Storm, Sigyn Therapy extracts pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators from the bloodstream.
  • An additional study modeled the ability of Sigyn Therapy ability to address CytoVesicles that transport inflammatory cargos throughout the bloodstream.
  • The Company also conducted a first-in-mammal pilot study that demonstrated the safe administration of Sigyn Therapy during six-hour treatment exposures.
  • Virus-induced Cytokine Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19) infections.To learn more, visit www.SigynTherapeutics.com .

Sigyn Therapeutics, Inc. Announces Participation in the Q3 Virtual Investor Summit

Retrieved on: 
Monday, August 16, 2021

To calm the Cytokine Storm, Sigyn Therapy extracts pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators from the bloodstream.

Key Points: 
  • To calm the Cytokine Storm, Sigyn Therapy extracts pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators from the bloodstream.
  • An additional study modeled the ability of Sigyn Therapy ability to address CytoVesicles that transport inflammatory cargos throughout the bloodstream.
  • The Company also conducted a first-in-mammal pilot study that demonstrated the safe administration of Sigyn Therapy during six-hour treatment exposures.
  • This equates to more than 40 acres of surface adsorption area in each Sigyn Therapy device.

Sigyn Therapeutics CEO Note: A Treatment Candidate to Address Bloodstream Pathogens, Deadly Toxins and Inflammatory Disease Targets

Retrieved on: 
Tuesday, August 10, 2021

Sigyn Therapeutics was founded on the belief that a properly designed medical device could address sepsis and other life-threatening inflammatory conditions that remain beyond the reach of drug therapies.

Key Points: 
  • Sigyn Therapeutics was founded on the belief that a properly designed medical device could address sepsis and other life-threatening inflammatory conditions that remain beyond the reach of drug therapies.
  • Since December 2020, we reported results from a series of studies that have demonstrated first-in-industry capabilities of Sigyn Therapy to address pathogen sources of inflammation, deadly toxins and relevant inflammatory mediators.
  • Our adsorbent formulation provides more than 170,000 square meters of surface area on which to adsorb and remove bloodstream targets.
  • Sigyn Therapy has been demonstrated to address inflammatory targets as well as pathogen sources of inflammation whose molecular size can exceed 100 nanometers in size.

Humanigen’s Partner in South Korea Receives Ministry of Food and Drug Safety (MFDS) Approval to Conduct Phase 1 Study of Lenzilumab

Retrieved on: 
Thursday, July 22, 2021

Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigens Phase 3 LIVE-AIR study.

Key Points: 
  • Support for conditional approval would be based on data from this phase 1 study and the existing data from Humanigens Phase 3 LIVE-AIR study.
  • We are hopeful that these data, alongside data generated in Korea by our partners, will allow for the use of lenzilumab in South Korea.
  • Like many countries, South Korea is experiencing rising number of COVID-19 cases, particularly due to the spread of the Delta variant.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

EQS-News: Relief Reports that its U.S. Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Retrieved on: 
Tuesday, July 20, 2021

Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19

Key Points: 
  • Collaboration Partner has Presented Evidence that Aviptadil Helps to Prevent Cytokine Storm in Patients with COVID-19
    Relief Reports that its U.S.
  • They reported that the cytokine data were collected as part of the U.S. phase 2b/3 trial of aviptadil compared to placebo in critically ill patients with COVID-19 respiratory failure.
  • Relief focuses primarily on clinical-stage programs based on molecules with a history of clinical testing and use in human patients or a strong scientific rationale.
  • In addition, Relief's recently completed acquisition of APR Applied Pharma Research brings a diverse pipeline of marketed and development-stage programs.

UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review

Retrieved on: 
Friday, July 9, 2021

Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdoms (UKs) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.

Key Points: 
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), today announced its submission for Marketing Authorization for lenzilumab in COVID-19, begun in June 2021, has been accepted by the United Kingdoms (UKs) Medicines and Healthcare Products Regulatory Agency (MHRA) for expedited COVID-related rolling review, with assessment expected to occur more rapidly than a standard rolling review.
  • We are grateful this submission will receive expedited consideration by MHRA, said Cameron Durrant, CEO of Humanigen.
  • Humanigen, Inc. (Nasdaq: HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called cytokine storm.
  • Humanigens Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

Results of Biomarck Clinical and Preclinical Studies of BIO-11006 in ARDS to be Presented at the 2021 ARDS Drug Development Summit

Retrieved on: 
Wednesday, July 7, 2021

At 28 days there were 7 deaths (37%) in the placebo arm and 4 deaths (21%) in the BIO-11006 treatment arm.

Key Points: 
  • At 28 days there were 7 deaths (37%) in the placebo arm and 4 deaths (21%) in the BIO-11006 treatment arm.
  • Treatment with BIO-11006 prevented development of ARDS, reversed established ARDS and prevented neutrophil influx into the lungs.
  • It is hoped that these results can now be repeated in a larger clinical trial currently being planned.
  • Inhibiting MARCKS with our peptides reduces the adverse effects of inflammation, including acute respiratory distress syndrome (ARDS) and cytokine storm.

Results of Biomarck Phase II Study of BIO-11006 in Patients with ARDS to be Presented at the 2021 ATS Annual Meeting

Retrieved on: 
Wednesday, May 12, 2021

Safety of BIO-11006 was confirmed when administered at a dose of 125 mg BID for up to 28 days.

Key Points: 
  • Safety of BIO-11006 was confirmed when administered at a dose of 125 mg BID for up to 28 days.
  • Rapid and faster improvements in oxygenation were observed in patients receiving BIO-11006 compared to placebo (half normal saline), together with decreases in pro-inflammatory cytokines.
  • Inhibiting MARCKS with our peptides reduces the adverse effects of inflammation, including acute respiratory distress syndrome (ARDS) and cytokine storm.
  • In vivo data demonstrate that BIO-11006 and other peptides in the Biomarck pipeline inhibit inflammation in dermatology and ophthalmology models.