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.