On September 8, 2022 Propella Therapeutics, Inc. ("Propella" or "the Company"), a private, clinical-stage biopharmaceutical company developing best-in-class oncology therapeutics, reported that Dr. Jose Avitia of the New Mexico Cancer Center will present data from the Company’s ongoing Phase 1/2 trial of PRL-02 for the treatment of advanced prostate cancer on Sunday, September 11 at 12:00 pm at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 (Press release, Propella Therapeutics, SEP 8, 2022, View Source [SID1234619260]). Details of the poster presentation are below:

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Abstract: 2264
Title: 1/2a study of PRL-02, a long-acting IM depot injection of abiraterone decanoate in patients with prostate cancer (NCT04729114)
Presenter: Jose Avitia, M.D.
Date: September 11, 2022
Time: 12 pm CEST, Location: Hall 4, Paris Expo Porte de Versailles, Paris, France
Presentation Number: 1386P

The presentation will highlight results from the ongoing dose-escalation part of the Phase 1/2 study (NCT04729114) in 15 patients who have been treated at five different doses of PRL-02 (180mg; 360mg; 720mg; 1260mg; 1800mg), including safety, tolerability and response data.

Propella Therapeutics is focused on the creation of a pipeline of proprietary oncology therapeutics that utilize lymphatic system delivery. The Company’s most advanced clinical candidate, PRL-02 (abiraterone decanoate), is a long-acting, selective CYP17 lyase inhibitor that has been designed for optimal uptake through the lymphatic system so that a precise level of abiraterone can be released to continuously block CYP17 lyase over a three-month period, thereby reducing the risk of tumor breakthrough. PRL-02 is currently in an open-label, multi-center Phase 1/2 study for the treatment of metastatic prostate cancer.

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. A large body of both historic and modern data support a role for androgens in prostate cancer pathogenesis and progression. The only approved androgen biosynthesis inhibitor approved for the treatment of prostate cancer, Zytiga (oral abiraterone acetate), blocks the CYP17 lyase enzyme that is required for the biosynthesis of androgens, including testosterone, but also unnecessarily blocks the CYP17 hydroxylase enzyme activity, resulting in a large accumulation of mineralocorticoids that can produce a constellation of side effects (hypertension, hypokalemia, edema) and upstream steroids such as progesterone that can further stimulate prostate cancer growth. PRL-02 is a patented prodrug of abiraterone designed for lymphatic targeting of tissues and tumors that express the CYP17 lyase 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 lyase enzyme for 3 months, while avoiding adverse liver and drug-drug interaction effects and the accumulation of steroids that can further stimulate prostate cancer and produce the symptoms of mineralocorticoid excess that arise from unwanted CYP17 hydroxylase inhibition.