Acute kidney injury

AM-Pharma Initiates Phase 2 Trial of Ilofotase Alfa for Cardiac Surgery-Associated Renal Damage

Retrieved on: 
Tuesday, January 16, 2024

CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery.

Key Points: 
  • CSA-RD is defined as the long-term loss of renal function in cardiac surgery patients and arises from acute kidney injury (AKI) immediately following the surgery.
  • Ilofotase alfa has a proven safety and tolerability profile and a strong record of renal protective effects as observed in previous clinical studies.
  • Notably, prior Phase 2 and Phase 3 trials with ilofotase alfa demonstrated significant improvements in Major Adverse Kidney Events by day 90 (MAKE90) in sepsis-associated AKI.
  • Ilofotase alfa was recently evaluated in a Phase 1b pilot study as enzyme replacement therapy in hypophosphatasia (HPP) patients.

Arch Biopartners Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 10, 2024

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • There is no treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

Arch Biopartners Receives Approval from the Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Wednesday, January 3, 2024

TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • With the Ministry of Health (MoH) approval for the trial, Arch can now proceed to contract and activate clinical sites in Turkey.
  • Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated.

SeaStar Medical Updates Subject Enrollment in its Pivotal Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury

Retrieved on: 
Thursday, December 28, 2023

DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

Key Points: 
  • DENVER, Dec. 28, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces enrollment of 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating the safety and efficacy of its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
  • “Over the past six weeks we have enrolled five subjects in this clinical trial while also continuing progress in activating additional clinical sites,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We are grateful to the dedicated investigators and their research staff who are working diligently to help validate the efficacy and safety of the SCD in this vulnerable population.”
    “We look forward to providing periodic updates on patient enrollment and site activations as this important trial progresses,” said Eric Schlorff, CEO of SeaStar Medical.
  • “We believe the more than 200,000 U.S. adult patients each year with AKI who require CKRT deserve a better treatment option.

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

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

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

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

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

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.