Acute kidney injury

Arch Biopartners Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Thursday, December 21, 2023
Clinical trial, Liver, Arch, AKI, Conlon, Reperfusion, Risk, IRI, Prevalence, Ethics, Disease, Mortality, TMX Group, Science Advances, Cardiopulmonary bypass, Inflammation, CPB, Renal replacement therapy, National Research Council, Oxygen, Acute kidney injury, OTCQB, CABG, MOH, Health Canada, Kidney, Injury, Patient, Ischemia, Dialysis, Pharmaceutical industry

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January.
  • Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February.
  • Quote from Richard Muruve, CEO of Arch Biopartners Inc:
    “We look forward to a positive decision from the MoH, which will permit enrollment of Turkish cardiac surgery patients into the trial.

Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

Retrieved on: 
Wednesday, December 13, 2023
Clinical trial, Phase, Liver, Arch, Food, AKI, Conlon, Reperfusion, Risk, IRI, FDA, Prevalence, Disease, Mortality, TMX Group, Science Advances, Cardiopulmonary bypass, Inflammation, Investigational New Drug, CPB, Renal replacement therapy, National Research Council, Oxygen, Acute kidney injury, OTCQB, CABG, Health Canada, Kidney, Patient, Safety, Ischemia, Dialysis, Pharmaceutical industry

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The FDA granted the Company permission to proceed with a Phase II trial in late June .
  • Quote from Richard Muruve, CEO of Arch Biopartners Inc:
    “The clinical trial application submitted to Health Canada is the result of clinical interest in Canada to support our Phase II trial targeting CS-AKI.
  • LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in pre-clinical models , providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

SeaStar Medical Forms Scientific Advisory Board of World-Renowned Pediatric and Adult Clinical Experts

Retrieved on: 
Wednesday, December 13, 2023
SCD, Associate, Hospital, Baylor College of Medicine, Food, AKI, Letter, FDA, Medical director, HDE, Nephrology, MD, Doctor of Philosophy, SAB, SeaStar, University, Acute kidney injury, Patient, Pharmaceutical industry

DENVER, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces the formation of the SeaStar Medical Scientific Advisory Board (SAB).

Key Points: 
  • DENVER, Dec. 13, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of dysregulated immune responses including hyperinflammation on vital organs, announces the formation of the SeaStar Medical Scientific Advisory Board (SAB).
  • The SAB is comprised of world-renowned international pediatric and adult clinical experts including nephrologists, critical care intensivists and translational scientists who will advise on the Company’s technology capabilities, share insights on emerging trends in healthcare, and advise on the Company’s critical care and acute kidney injury (AKI) clinical development programs.
  • “Science and innovation are the foundational pillars of SeaStar Medical and key to our competitive advantage,” said Eric Schlorff, CEO of SeaStar Medical.
  • “The advisory board also advised on design elements of our ongoing, pivotal NEUTRALIZE-AKI Phase 3 study with the SCD in adult patients with AKI.

Largest study to date of high-dose methotrexate associated acute kidney injury supports the use of Voraxaze® (glucarpidase)

Retrieved on: 
Monday, December 11, 2023
MMSc, Hospital, AKI, Division, Cone Health Women's Hospital, Mortality, Neutropenia, SCR, Society, Odds ratio, Observational study, Acute kidney injury, Transaminase, MPH, Patient, Harvard Medical School, Nursing

West Conshohocken, PA, Dec. 11, 2023 (GLOBE NEWSWIRE) -- BTG Pharmaceuticals, a SERB company, announces the presentation of the largest study to date of patients with high-dose methotrexate (HDMTX) associated Acute Kidney Injury (AKI) treated with and without glucarpidase.

Key Points: 
  • West Conshohocken, PA, Dec. 11, 2023 (GLOBE NEWSWIRE) -- BTG Pharmaceuticals, a SERB company, announces the presentation of the largest study to date of patients with high-dose methotrexate (HDMTX) associated Acute Kidney Injury (AKI) treated with and without glucarpidase.
  • Among the 708 patients with HDMTX-AKI, 209 (29.5%) were treated with glucarpidase and 499 (70.5%) were not.
  • Treatment with glucarpidase was associated with a 2.41-fold higher adjusted odds of kidney recovery at hospital discharge (95% CI, 1.33–4.37) compared to those not treated with glucarpidase.
  • “This is the largest study to date of HDMTX-AKI,” said study author Dr. Shruti Gupta, MD, MPH, Director of Onconephrology in the Division of Renal Medicine, Brigham and Women's Hospital.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023
Chronic kidney disease, Neutrophil, Acute respiratory distress syndrome, STEC-HUS, Cardiorenal syndrome, Safety, Food, Hepatorenal syndrome, University, AKI, HDE, Risk, ICU, Clinical trial, Monocyte, Mortality, CBER, Sepsis, Patient, Nephrology, Insurance, Research, Letter, Dialysis, Approvable letter, FDA, G&A, Child, Standard of care, Acute kidney injury, Partnership, Nephron, Clinical study design, R, Hospital, SCD, Physician, CKRT, Karger Publishers, PMA, HIV disease progression rates, Pharmaceutical industry, Nursing, Dietary supplement, Cryptocurrency

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Three Articles in the Journal of Pharmaceutical Analysis Uncover Previously Unknown Drug and Disease Mechanisms

Retrieved on: 
Friday, December 15, 2023
Kidney, OAT, Chronic pain, Live Phish Volume 13, Hope, Colorectal cancer, Acute kidney injury, Recycling, CRC, Cytoplasm, Mouse, Analgesic, MRP4, MOR, Dicarboxylic acid, Endocytosis, Cancer, Kynurenic acid, Morphine, Biomarker, Rat, CDK5, JPA, Histone deacetylase inhibitor, Pharmaceutical industry

XI'AN, China, Dec. 15, 2023 /PRNewswire/ -- Long-term use of analgesics such as morphine leads to "tolerance" that reduces drug efficacy. In such cases, dose escalation may be required to achieve the same analgesic effects. The key molecular mechanism of morphine tolerance is its inefficiency in inducing mu-opioid receptor (MOR) endocytosis. None of the currently available strategies to counter morphine tolerance address this underlying molecular mechanism. Moreover, understanding how drugs work is crucial to determine their efficacy. There is also an unmet need for new diagnostic biomarkers that can help identify diseases at an early stage. The October issue of JPA features three articles that address these issues and systematically lay a foundation for future studies and treatment strategies.

Key Points: 
  • XI'AN, China, Dec. 15, 2023 /PRNewswire/ -- Long-term use of analgesics such as morphine leads to "tolerance" that reduces drug efficacy.
  • The October issue of JPA features three articles that address these issues and systematically lay a foundation for future studies and treatment strategies.
  • In the second study , researchers dug deeper into the anticancer mechanisms of the drug 'pracinostat,' which is a histone deacetylase inhibitor (HDACi).
  • Corresponding author Prof. Xinan Wu speculates by saying, "Our findings could aid in adjusting drug dosage or predicting renal injury via OAT channels."

Mission Therapeutics announces US FDA approval to initiate Phase II clinical trial of its lead asset MTX652 in Acute Kidney Injury

Retrieved on: 
Thursday, December 14, 2023
Kidney, Parkinson's disease, Renal replacement therapy, Food, Therapy, Acute kidney injury, AKI, US Foods, IND, Risk, Disease, Patient, Mission, FDA, Mitophagy, Pharmaceutical industry

Dr Anker Lundemose, Chief Executive Officer of Mission Therapeutics, said: "The FDA's approval of our Phase II clinical study for our lead asset MTX652 marks a major milestone for Mission.

Key Points: 
  • Dr Anker Lundemose, Chief Executive Officer of Mission Therapeutics, said: "The FDA's approval of our Phase II clinical study for our lead asset MTX652 marks a major milestone for Mission.
  • We now have two USP30 inhibitors advancing through clinical trials, MTX652 for acute kidney injury and MTX325 for Parkinson's Disease, validating our unique approach and the breadth of our assets."
  • Dr Suhail Nurbhai, Chief Medical Officer of Mission Therapeutics, said: "Recent reports suggest that up to 50% of high-risk patients suffer acute kidney injury following heart surgery[i] [ii].
  • We are delighted to have received this approval and look forward to starting this trial in 2024."

Mission Therapeutics announces US FDA approval to initiate Phase II clinical trial of its lead asset MTX652 in Acute Kidney Injury

Retrieved on: 
Thursday, December 14, 2023
Kidney, Parkinson's disease, Renal replacement therapy, Food, Therapy, Acute kidney injury, AKI, US Foods, IND, Risk, Disease, Patient, Mission, FDA, Mitophagy, Pharmaceutical industry

Dr Anker Lundemose, Chief Executive Officer of Mission Therapeutics, said: "The FDA's approval of our Phase II clinical study for our lead asset MTX652 marks a major milestone for Mission.

Key Points: 
  • Dr Anker Lundemose, Chief Executive Officer of Mission Therapeutics, said: "The FDA's approval of our Phase II clinical study for our lead asset MTX652 marks a major milestone for Mission.
  • We now have two USP30 inhibitors advancing through clinical trials, MTX652 for acute kidney injury and MTX325 for Parkinson's Disease, validating our unique approach and the breadth of our assets."
  • Dr Suhail Nurbhai, Chief Medical Officer of Mission Therapeutics, said: "Recent reports suggest that up to 50% of high-risk patients suffer acute kidney injury following heart surgery[i] [ii].
  • We are delighted to have received this approval and look forward to starting this trial in 2024."

Prytime Medical Announces 500th Patient Case Using pREBOA-PRO™ Catheter Designed for True Partial REBOA

Retrieved on: 
Tuesday, December 5, 2023
Organ, Research, SAN, Center of excellence, AKI, Partial, Surgeon, Patient, Science, REBOA, MD, Trauma, Acute kidney injury, Bleeding, Hospital, Physician, PROMPT, Aorta, Blood pressure, Medical device, Medical imaging, Dentistry, Pharmaceutical industry

SAN ANTONIO, Dec. 5, 2023 /PRNewswire-PRWeb/ -- Prytime Medical Devices Inc, The REBOA Company™, the leading innovator and global provider of lifesaving REBOA products for minimally invasive, endovascular hemorrhage control, announced reaching the milestone of 500 patient uses with its lifesaving pREBOA-PRO™ catheter.

Key Points: 
  • Partial REBOA, or partial occlusion of the aorta, allows the viscera to be sufficiently perfused during the REBOA procedure.
  • "When we launched pREBOA-PRO™ in 2021, we assumed that partial REBOA using pREBOA-PRO™ would have an enhanced value proposition from complete REBOA.
  • "The physicians at the Centers of Excellence continue to invest in additional research to broaden our understanding of partial REBOA using the pREBOA-PRO™ catheter."
  • In March 2023, Prytime Medical announced the launch of the Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) Study, the first large-scale multicenter prospective study for Partial REBOA.

Roivios® announces final patient enrollment in feasibility trial for JuxtaFlow® Renal Assist Device (RAD)

Retrieved on: 
Monday, December 4, 2023
Sale, Disease, LJ, AKI, Risk, Surgeon, Mortality, Patient, RAD, Research, URPL, Acute kidney injury, Kidney, Geography, Survival, Doctor of Philosophy, Hospital, Percutaneous coronary intervention, Medical device, Nursing, E pluribus unum

"When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment," said Prof. Petrovic.

Key Points: 
  • "When we began this feasibility trial, we anticipated the use of the JuxtaFlow RAD to be an exciting moment," said Prof. Petrovic.
  • Cardiac surgery-associated AKI (CSA-AKI) occurs in up to 73% of patients who have pre-existing renal insufficiency documented as part of their standard pre-surgical workup1.
  • The JuxtaFlow RAD is used in the hospital setting and is designed to enable the kidneys to function optimally and thereby improve overall patient outcomes.
  • The BIPASS-AKI feasibility trial was being conducted pursuant to the regulations of both ALIMS in Serbia and URPL in Poland.