Propella Therapeutics, Pittsboro, NC, and the National Cancer Institute (NCI), part of the National Institutes of Health, have entered into a cooperative research and development agreement (CRADA). Under this new partnership, Propella and NCI will conduct a multi-center clinical trial to evaluate abiraterone decanoate as a new therapy for metastatic prostate cancer.
Propella holds US Patent 10,792,292, which protects multiple new long-acting, injectable, prodrugs of abiraterone, and includes composition of matter, method of manufacturing, and method of treatment claims. The acetate prodrug of abiraterone, which is given by mouth daily, is a current standard of care for advanced prostate cancer. Abiraterone acetate produces varying blood concentrations of abiraterone metabolites, including high levels that may produce side effects and low levels that may not be effective. Preclinical data indicate that a single injection of Propella’s novel intramuscular (IM) formulation of abiraterone decanoate can deliver more precise drug levels that may prove effective for up to 3 months, potentially providing patients with both greater drug effectiveness and assurance of increased safety.
Propella presented select preclinical findings on Feb. 11, 2021, at the (virtual) annual meeting of The American Society of Clinical Oncology, Genitourinary Division (GU ASCO) that confirmed large and continuous 3-month reductions in testosterone following a single IM injection.
“We’re gratified to have had the opportunity to present compelling preclinical program results at the prestigious GU ASCO conference, and to work collaboratively with the scientists at the National Cancer Institute,” says Propella President and CEO William Moore, PhD. “The upcoming clinical trial has the potential for abiraterone decanoate to improve the standard of care for patients with advanced prostate cancer.”
Under the CRADA, Propella will file and hold the Investigational New Drug application (IND) while NCI will provide clinical research and development expertise along with pharmacokinetic and clinical pharmacology insights and analyses.
According to William Douglas Figg Sr, PharmD, senior investigator and head of the clinical pharmacology program at the NCI, “Propella’s intramuscular formulation of abiraterone, abiraterone decanoate, is an interesting new agent and we look forward to investigating its potential as a therapy choice for men with prostate cancer.”
For more information, visit Propella.
Featured image: Prostate cancer of a human, highly detailed segment of panorama. Photomicrograph as seen under the microscope, 10x zoom. (Photo: ID 66313345 © Viachaslau Bondarau | Dreamstime.com)