RESEARCH TRIANGLE PARK – Pittsboro-based startup Propella Therapeutics is teaming up with the National Cancer Institute (NCI) to evaluate its new treatment for metastatic prostate cancer.
NCI and Propella have entered into a Cooperative Research and Development Agreement to run a multi-center clinical trial that will examine abiraterone decanoate. Propella holds a patent on this injectable prodrug of abiraterone. Prodrugs are inactive compounds that the body metabolizes into drugs.
Abiraterone is a powerful CYP 17 enzyme inhibitor that stops the production of testosterone and other male hormones – or androgens – that feed prostate cancer cells. Current treatments use abiraterone acetate, which if taken orally on a daily basis can make the body produce too much or too little abiraterone. And that can cause toxicity or be ineffective against cancer tumors.
Propella’s prodrug is different. The company said a single intramuscular injection of abiraterone decanoate can deliver more-precise drug levels. And that may significantly reduce testosterone levels in men for up to three months. The company presented select preclinical findings at the annual meeting of the American Society of Clinical Oncology, Genitourinary Division, earlier in February.
“We’re grateful to have 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,” said Propella President and CEO William Moore, Ph.D. “The upcoming clinical trial has the potential for abiraterone decanoate to improve the standard of care for patients with advanced prostate cancer.”
Propella was created in 2020 as part of a strategic reorganization of Maryland-based Vizuri Health Sciences, LLC. The company focuses on finding off-patent medications that it can improve and rapidly develop into new, more-effective treatments. Its drug product candidates are eligible for the U.S. Food and Drug Administration’s 505 (b) (2) program. This pathway streamlines the development and authorization of new pharmaceutical products that use already approved active pharmaceutical ingredients, or APIs.
The program reduces the need for improved APIs to duplicate earlier studies performed with the originator drug, which saves both developmental time and money. Therapies approved under 505 (b) (2) may qualify for five or seven years of market exclusivity in the U.S.
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