Sarcoplasmic reticulum

Windtree Renews Agreement with Chang Gung University for Scientific Collaboration to Further SERCA2a Research

Retrieved on: 
Thursday, February 1, 2024

The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.

Key Points: 
  • The scientific collaboration includes the Company’s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.
  • SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias.
  • Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients.
  • Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock.

Windtree Announces Notice of Allowance from the US Patent and Trademark Office for a New Istaroxime Patent

Retrieved on: 
Tuesday, October 25, 2022

A notice of allowance is issued by the USPTO to indicate that the application has passed examination.

Key Points: 
  • A notice of allowance is issued by the USPTO to indicate that the application has passed examination.
  • Istaroxime is an investigational drug candidate being studied in early cardiogenic shock and acute heart failure.
  • The U.S. Patent, titled: Istaroxime-Containing Intravenous Formulation for the Treatment of Acute Heart Failure (AHF), is a continuing patent application of the expedited U.S. Track One filing by Windtree, which resulted in U.S. Patent No.
  • We are pleased with this notice of allowance for a new patent that will continue to strengthen the istaroxime patent estate, said Craig Fraser, President and Chief Executive Officer of Windtree.

Windtree Is Leveraging Positive Istaroxime Early Cardiogenic Shock Results to Proactively Engage in Licensing Discussions and Explore Strategic Opportunities to Realize Greater Shareholder Value

Retrieved on: 
Wednesday, June 29, 2022

WARRINGTON, Pa., June 29, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for acute cardiovascular disorders, today provided an update to its strategy and pursuit related to partnerships and transactions.

Key Points: 
  • During the second quarter, Windtree announced positive clinical results for istaroxime in early cardiogenic shock caused by heart failure that were both consistent with and complementary to previous positive acute heart failure studies.
  • The positive data supported the advancement of a unique new development program in cardiogenic shock due to heart failure.
  • Given this, the Company has begun various proactive engagements and discussions with the intent to create and realize greater shareholder value.
  • The recent positive results in early cardiogenic shock have increased both outbound and inbound business development interests and have resulted in numerous discussions to explore global and regional licensing and other forms of partnership.

Windtree Presents Data from its Positive SEISMiC Phase 2 Study of Istaroxime in Early Cardiogenic Shock in a Late-Breaker Presentation at the European Society of Cardiology Heart Failure Meeting in Madrid

Retrieved on: 
Monday, May 23, 2022

WARRINGTON, Pa., May 23, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today presented data from its positive Phase 2 study of istaroxime in early cardiogenic shock in a late-breaker presentation at the European Society of Cardiology Heart Failure Meeting in Madrid, Spain. The study met its primary endpoint of significantly improved SBP, the critical clinical objective in treating patients with cardiogenic shock, compared to the control group at 6 hours. The significant improvement in blood pressure profile persisted through 24 hours. The study met several other secondary endpoints including assessments of cardiac function.

Key Points: 
  • Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs.
  • Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat SCAI class B cardiogenic shock patients is highly needed.
  • Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function.
  • Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release.

Windtree Announces Conference Call to Present Data from its Positive SEISMiC Phase 2 Study of Istaroxime in Early Cardiogenic Shock

Retrieved on: 
Monday, May 16, 2022

Also being presented will be next steps in development and the broader outlook for the Company.

Key Points: 
  • Also being presented will be next steps in development and the broader outlook for the Company.
  • The call will also be webcast live and will be available by clicking the link HERE .
  • Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat SCAI class B cardiogenic shock patients is highly needed.
  • Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release.

Windtree Therapeutics Announces Late-Breaker Presentation on Phase 2 SEISMiC Study Results of Istaroxime in Early Cardiogenic Shock at the European Society of Cardiology (ESC) Heart Failure Conference

Retrieved on: 
Wednesday, April 20, 2022

At the late-breaker presentation, Dr. Metra will present additional data and details from the Study.

Key Points: 
  • At the late-breaker presentation, Dr. Metra will present additional data and details from the Study.
  • Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs.
  • Windtree Therapeutics, Inc.is advancing multiple late-stage interventions for acute cardiovascular and acute pulmonary disorders to treat patients in moments of crisis.
  • Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release.

Windtree Announces Positive Topline Results from Its Phase 2 SEISMiC Study of Istaroxime in Early Cardiogenic Shock

Retrieved on: 
Wednesday, April 20, 2022

The SEISMiC Phase 2 study in early cardiogenic shock is an international, randomized, double blind, placebo- controlled study enrolling 60 patients with Society for Cardiovascular Angiography & Interventions (SCAI) stage B early cardiogenic shock due to severe heart failure with systolic blood pressures (SBP) between 75-90 mmHg.

Key Points: 
  • The SEISMiC Phase 2 study in early cardiogenic shock is an international, randomized, double blind, placebo- controlled study enrolling 60 patients with Society for Cardiovascular Angiography & Interventions (SCAI) stage B early cardiogenic shock due to severe heart failure with systolic blood pressures (SBP) between 75-90 mmHg.
  • Study drug was infused for 24 hours in a 1:1 randomization to placebo or istaroxime.
  • Two istaroxime doses were evaluated, 1.5 g/kg/min in the first group and 1.0 g/kg/min in the next group.
  • Craig Fraser, President and CEO of Windtree stated, It is worth noting the area of cardiogenic shock is complementary to our AHF program.

Windtree Completes Enrollment of Phase 2 Study of Istaroxime in Early Cardiogenic Shock

Retrieved on: 
Tuesday, March 15, 2022

The study is an international, randomized double-blind, placebo-controlled study designed to assess the efficacy and safety of istaroxime and to support an intended pathway for the development in early cardiogenic shock.

Key Points: 
  • The study is an international, randomized double-blind, placebo-controlled study designed to assess the efficacy and safety of istaroxime and to support an intended pathway for the development in early cardiogenic shock.
  • The study has enrolled 60 Society for Cardiovascular Angiography & Interventions (SCAI) class B early cardiogenic shock patients with severe heart failure (30 assigned to istaroxime and 30 assigned to placebo) and systolic blood pressures (SBP) between 75-90 mmHg.
  • We are very pleased to have completed enrollment in the study of istaroxime in early cardiogenic shock due to heart failure.
  • Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat SCAI class B cardiogenic shock patients is highly needed.

Windtree Announces U.S. Patent and Trademark Office Issuance of New U.S. Istaroxime Patent

Retrieved on: 
Wednesday, December 15, 2021

The U.S. Patent, titled: Istaroxime-Containing Intravenous Formulation for the Treatment of Acute Heart Failure (AHF), covers longer infusion durations of istaroxime for improved outcomes in the treatment of acute heart failure.

Key Points: 
  • The U.S. Patent, titled: Istaroxime-Containing Intravenous Formulation for the Treatment of Acute Heart Failure (AHF), covers longer infusion durations of istaroxime for improved outcomes in the treatment of acute heart failure.
  • In particular, the patent refers to results in improvement in at least one echocardiographic indicator of diastolic function, which Windtree attributes to the SERCA2a mechanism of action of istaroxime and its metabolites.
  • Istaroxime is an investigational drug candidate being studied in acute heart failure and early cardiogenic shock.
  • Given the multiple development projects and programs we are advancing with istaroxime, we are pleased to have this patent contribute to the intellectual property protection of istaroxime, said Craig Fraser, CEO and President.

Research Finds U.S. Cardiogenic Shock Patients Have High Hospital Inpatient Mortality and Long Length of Stay – Adding to Previously Reported Need for New Pharmacologic Innovation

Retrieved on: 
Monday, November 22, 2021

Cardiogenic shock is a serious condition that occurs when the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs.

Key Points: 
  • Cardiogenic shock is a serious condition that occurs when the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs.
  • U.S. hospital claims data reveals that inpatient mortality for cardiogenic shock patients was 30% in 2020.2 To help explain the relative severity of cardiogenic shock, the acute myocardial infarction (e.g.
  • Additionally, U.S. hospital claims data was assessed to determine length of stay in the hospital for cardiogenic shock patients.
  • The istaroxime phase 2 study in early cardiogenic shock is an international, randomized, double blind, placebo- controlled study.