Mr. Zen
2 weeks ago
Windtree Therapeutics, Inc. (โWindtreeโ or the โCompanyโ) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it has successfully completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime in early cardiogenic shock caused by heart failure. The study is evaluating the ability of istaroxime to improve heart function and low blood pressure in the setting of early cardiogenic shock due to heart failure. The Company is looking to extend the positive results on these parameters as observed in the Companyโs first SEISMiC Phase 2 clinical study that was previously reported. In addition, the Company hopes that the study results will substantiate the encouraging observations from the Companyโs Phase 2 clinical study, indicating istaroxime has a favorable renal profile and does not increase cardiac arrhythmias. The SEISMiC Extension Study is utilizing longer dosing duration and tapering the dosing to assess the potential benefits.
Istaroxime is a novel first-in-class therapy that has demonstrated the ability to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure and maintaining or improving renal function in patients with compromised cardiac function in three positive Phase 2 trials enrolling patients with acute heart failure (AHF). Cardiogenic shock is a serious condition that can occur when AHF patients continue to deteriorate and the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Mortality rates are significant and, depending on severity, range from 7% to 40% in the U.S. There is a lack of satisfactory pharmacological intervention to reverse the condition as available therapies have unwanted side effects such as risk for arrhythmias, decreased blood pressure, and renal dysfunction that limit their usefulness and position them as โrescue medicinesโ for severe cases. The cardiogenic shock worldwide total market value is estimated to be $1.25 billion per year.
tw0122
2 months ago
The Company submits this request for withdrawal as it does not intend to pursue, at this time, the public offering to which the Registration Statement relates. The Registration Statement has not been declared effective by the Commission and no securities have been issued or sold under the Registration Statement. Accordingly, withdrawal of the Registration Statement is consistent with the public interest and the protection of investors, as contemplated by paragraph (a) of Rule 477.
The Company requests that, in accordance with Rule 457(p) under the Securities Act, all fees paid to the Commission in connection with the filing of the Registration Statement be credited for future use.
Pursuant to Rule 477(b), the Company understands that this request for withdrawal of the Registration Statement will be deemed granted as of the date hereof unless the Company receives notice from the Commission within 15 days of the date hereof that such request will not be granted.
If you have any questions or require any further information, please contact the Companyโs counsel, Goodwin Procter LLP, by calling Justin S. Platt, Esq. at (212) 459-7340.