Reperfusion injury

Vivacelle Bio Integrates Sub-Saharan Africa Strategy into Series B Financing Round

Retrieved on: 
Thursday, February 22, 2024
Blood pressure, Blood, School, Sepsis, Woman, IIA, Bleeding, Doctor of Philosophy, Resuscitation, The, Shock, MD, Diarrhea, Temperature, Septic, University, Nitric oxide, Shock (mechanics), Senior advisor, Finger, Life, Urinary tract infection, Risk, Internal bleeding, Pelvic floor dysfunction, Malaria, Hypovolemia, Nanoparticle, Gangrene, Neonatal sepsis, JD, Patient, Septic shock, Clinical trial, UMKC, Child, Reperfusion injury, Hypotension, Partnership

Targeted $20M Series B Round to include Sub-Saharan Africa in product development.

Key Points: 
  • Targeted $20M Series B Round to include Sub-Saharan Africa in product development.
  • Vivacelle Bio is partnering with Propelevate to drive the Sub-Saharan Africa strategy, which is fully integrated into its Series B financing round.
  • Through partnership with Propelevate, Vivacelle Bio will engage global health funders and stakeholders during final stages of product development, and Propelevate will drive Vivacelle Bio's go-to-market strategy for African markets upon regulatory approval.
  • "We are excited to partner with Vivacelle Bio because of their commitment to Sub-Saharan Africa.

Faraday Pharmaceuticals Announces Agreement with FDA on Interim Analysis of Phase 3 IOCYTE AMI-3 Trial Data and EU Notice of Intention to Grant Patent

Retrieved on: 
Thursday, January 4, 2024
SPA, Food, Reperfusion injury, PCI, STEMI, FDA, European, Patent, Ischemia, Death, European Patent Convention, Michael Faraday, Safety, EPO, Patient, Heart failure, Pharmaceutical industry

The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.

Key Points: 
  • The company also announced its receipt of a notice of “intention to grant” its FDY-5301 patent application from the European Patent Office (EPO), allowing for the expansion of FDY-5301’s protection across the European Union (EU) into 2035.
  • The SPA amendment optimizes the timing, based on the study’s current enrollment rate, and expands the data set of the interim analysis.
  • The trial is being conducted under a Special Protocol Agreement reached with the U.S. Food and Drug Administration.
  • For more information on the IOCYTE AMI-3 Phase 3 please visit ClinicalTrials.gov and reference Identifier NCT04837001 .

XBiotech Announces Enrollment Completion of Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke

Retrieved on: 
Tuesday, September 26, 2023
Oxygen, Stroke, Pharmacokinetics, Brain, Artery, Emergency medicine, Reperfusion injury, Trial of the century, Blood, Reperfusion, Death, Safety, Pharmaceutical industry, Medical imaging

AUSTIN, Texas, Sept. 26, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) Announces that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke.

Key Points: 
  • AUSTIN, Texas, Sept. 26, 2023 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) Announces that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke.
  • The last subject in a randomized, open-label, placebo-controlled Phase I dose escalation clinical study has been enrolled.
  • XBiotech discovered, manufactures, and is conducting this clinical study of Hutrukin.
  • The primary objective of the Phase I study is to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers.

Humacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma

Retrieved on: 
Tuesday, April 18, 2023
Infection, Biologics license application, Failure, Amputation, AC 25.1309-1, Aneurysm, Iliac artery, Reperfusion injury, Sale, Military personnel, Incidence, Polytetrafluoroethylene, Ischemia, Journal, Animal, Patient, HUMA, Host, Peripheral artery disease, FDA, HAV, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Medical imaging, Trauma

DURHAM, N.C., April 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced the publication of a preclinical study in the Journal of Trauma and Acute Care Surgery comparing the use of its Human Acellular Vessel (HAV) to expanded polytetrafluorethylene (ePTFE) grafts for vascular repair following arterial trauma. In the preclinical study the HAV performed better than ePTFE on multiple indices.

Key Points: 
  • In the preclinical study the HAV performed better than ePTFE on multiple indices.
  • In this comparative preclinical study, 36 pigs were randomly assigned to treatment groups receiving either the HAV or an ePTFE graft to reconstruct a severed iliac artery after vascular trauma.
  • At the conclusion of the study, the HAV and ePTFE implants were removed and histologically evaluated for host cellular response.
  • The publication of this preclinical study comes as Humacyte nears the completion of enrollment in its Phase 2/3 V005 clinical trial of the HAV in the repair of vascular trauma.

XBiotech Announces First Subject Enrollment in Phase I Clinical Trial for Hutrukin, a Novel Candidate Therapy for Stroke

Retrieved on: 
Monday, April 17, 2023
Oxygen, Stroke, Pharmacokinetics, Brain, Artery, Reperfusion injury, Trial of the century, Patient, Blood, Disease, Reperfusion, Death, Safety, Medical imaging, Pharmaceutical industry

Hutrukin is being developed as a novel treatment to reduce brain injury following ischemic stroke.

Key Points: 
  • Hutrukin is being developed as a novel treatment to reduce brain injury following ischemic stroke.
  • There are more than 10 million ischemic strokes each year—the leading cause of death and morbidity in the world today.
  • An ischemic stroke occurs when a blood clot forms in a blood vessel that supplies blood flow to brain.
  • Emergency use of “clot-busting” drugs or mechanical catheters to re-open arteries after a stroke is associated with a phenomenon known as reperfusion injury.

ROSALIND FRANKLIN UNIVERSITY STARTUP PREPARING FOR FDA IND FILING AND A PIVOTAL CLINICAL TRIAL ON NOVEL THERAPY FOR SUDDEN CARDIAC ARREST

Retrieved on: 
Thursday, February 2, 2023
Facial muscles, Arrest, Resuscitation, OHCA, Medicine, Critical Care Medicine (journal), ICU, EPO, CPR, Patient, Rosalind Franklin University of Medicine and Science, Oxygen, RTX, Clinical trial, SCA, Nephrology, Anemia, Food, Research, Cardiology, Drug discovery, Survival, Reperfusion injury, Physiology, FDA, Chronic kidney disease, Biophysics, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Chicago Medical School, RFU, IND, Pharmaceutical industry, Medical device

More than 350,000 people suffer an episode of out-of-hospital cardiac arrest (OHCA) each year in the U.S. but less than 10% survive.

Key Points: 
  • More than 350,000 people suffer an episode of out-of-hospital cardiac arrest (OHCA) each year in the U.S. but less than 10% survive.
  • RTx is looking to finalize its IND application during the first quarter of 2023 and to undertake a multi-center clinical trial early next year.
  • A positive result of the clinical trial will pave the way for FDA approval for clinical use and subsequent commercialization.
  • "It's our great hope," he said, "that this potential therapeutic solution for sudden cardiac arrest will save many lives in the U.S. and around the world."

Revive Therapeutics Ltd. Expands Life Offering to Quebec

Retrieved on: 
Thursday, December 15, 2022
Psilocybin, Acquisition, Reperfusion injury, NI, Canadian Securities Exchange, Revive, Disorder, Liver disease, Inflammation, Ischemia, Therapy, FDA, Offering, Person, Organ transplantation, Regulation, Sale, News, Risk, Indian stock exchange, Legislation, Part, CSE, Drug development, Orphan drug, SEDAR, Autoimmune hepatitis, Infection, Research, RVV, COVID-19, Unit, Security (finance), CBD

There is an amended and restated offering document dated December 14, 2022 (the “Offering Document”) related to the Offering that can be accessed under the Company’s profile at www.sedar.com and on the Company’s website at https://revivethera.com .

Key Points: 
  • There is an amended and restated offering document dated December 14, 2022 (the “Offering Document”) related to the Offering that can be accessed under the Company’s profile at www.sedar.com and on the Company’s website at https://revivethera.com .
  • As disclosed in the Offering Document, the company intends to use the net proceeds for general working capital purposes and clinical development.
  • Due to the Offering being expanded to Quebec investors, the Offering is now expected to close in one or more tranches with the first tranche anticipated to close on or before December 30, 2022.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Ltd. Announces Offering of Up to $5 Million

Retrieved on: 
Wednesday, November 30, 2022
Psilocybin, COVID-19, Autoimmune hepatitis, Regulation, RVV, Inflammation, Revive, Disorder, Part, Liver disease, Canadian Securities Exchange, Acquisition, Ischemia, NI, Legislation, Organ transplantation, Unit, Orphan drug, Drug development, SEDAR, News, Infection, Sale, Indian stock exchange, Research, Therapy, Risk, Offering, Person, CSE, FDA, Reperfusion injury, Pharmaceutical industry, Security (finance), CBD

There is an offering document (the Offering Document) related to the Offering that can be accessed under the Companys profile at www.sedar.com and on the Companys website at https://revivethera.com .

Key Points: 
  • There is an offering document (the Offering Document) related to the Offering that can be accessed under the Companys profile at www.sedar.com and on the Companys website at https://revivethera.com .
  • As disclosed in the Offering Document, the company intends to use the net proceeds for general working capital purposes and clinical development.
  • The Offering is anticipated to close on or about December 14, 2022, or such later date as the Company may determine.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Announces Update for Type C Meeting to Discuss Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Thursday, November 24, 2022
Psilocybin, COVID-19, Autoimmune hepatitis, RVV, Inflammation, Disorder, Liver disease, Acquisition, Ischemia, Patient, Organ transplantation, Coronavirus, Orphan drug, FDA, Drug development, Infection, Research, Therapy, CSE, Type, Safety, Reperfusion injury, Pharmaceutical industry, CBD

Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

Key Points: 
  • Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.
  • The Company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.

Revive Therapeutics Announces FDA Recommendation for Type C Meeting to Discuss Amended Protocol Agreement of Phase 3 Clinical Study for Bucillamine in the Treatment of COVID-19

Retrieved on: 
Tuesday, November 22, 2022
Psilocybin, COVID-19, Autoimmune hepatitis, RVV, Hospital, DSMB, Inflammation, Disorder, Liver disease, Safety, Acquisition, Ischemia, Patient, Organ transplantation, Coronavirus, Orphan drug, Drug development, Infection, Death, Research, Therapy, CSE, Data monitoring committee, Study, Type, FDA, Reperfusion injury, Pharmaceutical industry, Bucillamine, CBD

The FDA has now requested additional information, which would include clinical data, for them to agree on the Studys revised endpoints.

Key Points: 
  • The FDA has now requested additional information, which would include clinical data, for them to agree on the Studys revised endpoints.
  • The Company plans to go over with the FDA the overall development plan for Bucillamine in COVID-19 and further review the Pre-Dose selection data that would support the appropriate endpoints.
  • Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19.
  • With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders.