European Urology Today, the official newsletter of the European Association of Urology, publishes the results of the PCombi study
Pantarhei Oncology has developed a new concept for the endocrine treatment of locally infiltrating and/or metastatic prostate cancer in collaboration with two renowned Dutch urologists, Prof. Frans Debruyne, formerly at the Radboud UMC, Nijmegen and Prof. Jeroen van Moorselaar, Free University, Amsterdam. This collaboration has resulted in the performance of the prospective, randomized, double-blind, placebo-controlled PCombi study in four Dutch urology centers by Dr. Erik Roos (Sneek), Dr. Rik Somford (Nijmegen), Dr. Ton Roeleveld (Alkmaar) and Dr. Tjard de Haan (Zwolle) in men with advanced prostate cancer, who started androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist to suppress testosterone levels. Major side effects of ADT are loss of libido and sexual function, but since the loss of testosterone also implies the loss of testosterone derived estrogens, especially estradiol (E2), most side effects of ADT are related to estrogen deficiency. These side effects are the same as the symptoms of estrogen deficiency occurring in postmenopausal women and include hot flushes and sweatings, joint pain (arthralgia), sleep disturbances, mood changes and depression, fatigue, loss of energy, muscle weakness (sarcopenia), cognition problems, bone loss and an increased fracture risk with, especially in aging males, a higher risk of mortality.
The results of the Phase II PCombi study were recently published in the European Urology Open Science. The study has demonstrated several significant estrogen supplmentation and biochemical anti-tumor effects. Patients treated with E4 had fewer symptoms of estrogen deficiency than patients treated with placebo. The high dose E4 treatment was well-tolerated with no treatment-related cardiovascular adverse events.
European Urology Today, the official newsletter of the European Association of Urology, now reports on this publication: European Urology Today Vol. 33 No.5 – October 2021/ January 2022 by European Association of Urology (EAU) – Issue.
19th Association of Academic European Urologists Meeting (AAEU), December 2-5, 2021, Marseille (France)
On 5th of December 2021, Prof. Jeroen van Moorselaar of the Amsterdam University Medical Centre in the Netherlands, lectured during the annual meeting of the AAEU in Marseille on the results of the PCombi study sponsored by Pantarhei Oncology. The title of his lecture: Estetrol improves quality of life in advanced castration-sensitive prostate cancer: a randomized clinical trial.
According to Prof. Van Moorselaar, the results were well received. He got a lot of enthusiastic reactions from the audience. He will give the same presentation at the International Prostate Cancer Update (IPCU) in Utah (US) beginning of March 2022.
Pantarhei Oncology receives positive advice from the FDA to initiate Phase III development of estetrol for prostate cancer treatment
After having achieved proof-of-concept in human for estetrol (E4) as a potential combination treatment with androgen deprivation therapy (ADT) of advanced prostate cancer, Pantarhei submitted a Pre-Investigational New Drug Application (Pre-IND) to the US Food & Drug Administration (FDA) for guidance on the further development with this new combination treatment.
In a positive meeting with the FDA, the company has reached an agreement on their development plans including a proposal for a Phase III clinical study. Based on this outcome, the PCombi project (E4 for prostate cancer patients) is now ready to start Phase III, the final stage of development to bring the product to the market.
The next study will be a pivotal phase III, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of estetrol as co-treatment with ADT in patients with advanced prostate cancer. Main objectives are to evaluate E4 treatment for the prevention of estrogen deficiency symptoms caused by the ADT (such as hot flushes and bone loss) and for its additional anti-tumor effects.
The company is currently looking for a strategical or financial partner for further financing the development of this project.