Propella Therapeutics Inc. (Propella), a biopharmaceutical company focused on developing innovative, best-in-class oncology drugs, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PRL-02
| PITTSBORO, N.C., May 19, 2021 /PRNewswire/ -- Propella Therapeutics Inc. (Propella), a biopharmaceutical company focused on developing innovative, best-in-class oncology drugs, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for PRL-02 (abiraterone decanoate), a potentially best-in-class therapy for metastatic prostate cancer. Under the IND, Propella plans to initiate an open-label, phase 1/2a clinical study in June 2021. The phase 1 portion will have a dose-escalation design that will assess the safety, tolerability, pharmacokinetics, and preliminary clinical activity of PRL-02 in patients with metastatic prostate cancer. “We believe that abiraterone decanoate has the potential to be a more effective and convenient therapy for advanced prostate cancer than current standards of care,” said Propella President and CEO, William Moore. “We have strong preclinical data, and we’re excited to be initiating a first-in-human trial. This is a key milestone for us.” PRL-02 is a novel, long-acting prodrug of abiraterone. The acetate prodrug of abiraterone is the current standard of care for advanced prostate cancer. Abiraterone acetate produces varying daily blood concentrations of the active drug, abiraterone, including high levels that may produce side effects, including liver toxicity, and low levels that may not be effective. Preclinical results showed that a single dose of PRL-02, injected into the muscle, produced the precise concentrations of abiraterone that produced clinically relevant declines in testosterone for more than 12 weeks, with a better safety profile than oral abiraterone acetate, and without liver effects. “PRL-02 represents the first potent, long-acting androgen biosynthesis inhibitor and which has the potential to improve upon the safety and efficacy of chronic hormonal therapy for metastatic prostate cancer patients,” observed Daniel George, Professor of Medicine and Surgery, Divisions of Medical Oncology and Urology at the Duke University School of Medicine. “I am personally excited to see this agent enter the clinic.” Brendan Griffin Joins Propella as CFO Today, Propella also announced the appointment of Brendan Griffin to its leadership team as the company’s Chief Financial Officer (CFO). In this role, Mr. Griffin will lead Propella’s finance, business and corporate development, administrative and communications activities. “I’m pleased to be joining Propella at such a pivotal time in its trajectory,” explained Mr. Griffin. “I look forward to being part of this team as we work together to realize this company’s extraordinary potential.” Prior to joining Propella, Mr. Griffin served as a senior member of the biotechnology investment banking team at SVB Leerink, a leading investment bank that specializes in healthcare and the life sciences. At SVB Leerink, he completed over 100 transactions for clients across North America, Europe, and Asia, including more than 20 initial public offerings. Mr. Griffin earned a Master of Business Administration degree from the Tepper School of Business at Carnegie Mellon University, a Master of Public Policy Management degree from Heinz College of Public Policy at Carnegie Mellon University, and a Bachelor of Science degree from Elon University. Propella Therapeutics: Propella Therapeutics Inc. creates and develops innovative, best-in-class therapeutics designed to address key limitations of existing cancer therapies. The privately held development-stage company, based in Pittsboro, N.C., is dedicated to meeting the needs of cancer patients currently underserved by existing standards of care. propellatx.com Media and Investor Contact:
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