On June 29, 2021 Propella Therapeutics, Inc. ("Propella"), a private, clinical-stage biopharmaceutical company developing best-in-class oncology therapeutics, reported the dosing of the first patient in the Phase 1/2a clinical trial studying its lead patented product candidate, PRL-02 (abiraterone decanoate), for the treatment of metastatic prostate cancer (Press release, Propella Therapeutics, JUN 29, 2021, View Source [SID1234584461]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1 portion is an open-label, multi-center, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary clinical activity of PRL-02 and establish a recommended dose for the phase 2a portion (NCT04729114).

"PRL-02 may provide improved bioavailability and convenience over the currently available therapies while also providing patients a potentially safer treatment option than the approved androgen biosynthesis inhibitors" said Dr. Robert Dreicer, Professor of Medicine and Urology at the University of Virginia. "I am personally intrigued by the PRL-02 profile and its potential to be a clinically meaningful new option for the treatment of patients with metastatic prostate cancer."

According to William Moore, Propella Therapeutics President and CEO, "We are pleased to announce that the first patient has been dosed in the Phase 1/2a study evaluating our lead drug candidate, PRL-02, for the treatment of advanced prostate cancer. Propella’s core mission is to develop a robust pipeline of innovative therapeutics with significantly improved efficacy and safety for patients suffering from advanced forms of cancer by leveraging our expertise in medicinal chemistry and lymphatic targeting. We chemically engineered our next-generation androgen biosynthesis inhibitor, PRL-02, to avoid the high daily oral doses and hepatic safety warnings that appear on the label of approved abiraterone acetate products. Based upon its long duration of activity and superior therapeutic index in preclinical models, we believe PRL-02 will significantly improve upon the current standard of care."

About Metastatic Prostate Cancer

Prostate cancer is the most common non-skin cancer in men, and the second leading cause of cancer death, developing most often in older men. Metastatic disease occurs when prostate cancer cells travel through the lymphatic system or blood stream to other organs and tissues such as lymph nodes, liver, bone, and lungs. While early or localized prostate cancer remains highly curable, advanced prostate cancer) remains difficult to treat, with a 5-year survival rate of only 30%. Although there are several treatment options for metastatic prostate cancer, the reduction of androgen activity remains the most effective approach.

About PRL-02

PRL-02 is a next generation androgen biosynthesis inhibitor being developed for the treatment of prostate cancer. All androgen biosynthesis inhibitors approved for the treatment of prostate cancer block the CYP17 enzyme that is required for the biosynthesis of androgens, including testosterone. A large body of both historic and modern data support a role for androgens in prostate cancer pathogenesis and progression. PRL-02 is a patented prodrug of abiraterone designed for lymphatic targeting of tissues and tumors that express the CYP17 enzyme. PRL-02 is an intramuscular depot that, when given along with a gonadotropin releasing hormone agonist or antagonist, was engineered to precisely release the abiraterone needed to continuously block CYP17 enzyme for 3 months, while avoiding adverse liver and drug-drug interaction effects.