Heart Health Articles

EMEA Gives Official Scientific Advice On Clinical Phase IIb Efficacy Study Of Inecalcitol In Hormone-refractory Prostate Cancer

June 19, 2017

Hybrigenics, a bio-pharmaceutical company with a focus on research and development of new cancer treatments and specialized in protein interactions, announced that it has received the official scientific advice from the European Medicines Agency (EMEA) on Hybrigenics' clinical development plan for inecalcitol in hormone-refractory prostate cancer patients.

EMEA's recommendations back the protocol proposed by Hybrigenics and will facilitate authorizations by national health agencies in each European country where the Phase IIb clinical trial of high doses of oral inecalcitol in addition to intravenous cycles of Taxotere(R) will be implemented. It will be a double-blind placebo-controlled study on a minimum of 80 patients. The dose and frequency of administrations of inecalcitol are currently being determined in an open label dose-escalation Phase IIa trial now reaching 4 milligrams once and twice a day.

The objective of the Phase IIb study is to achieve clinical "proof-of-concept" (PoC) based on the proportion of patients who will experience a decline in prostate specific antigen (PSA) under treatment. The high response rate currently observed among patients in the ongoing Phase IIa tolerance study of inecalcitol provided the foundation for the proposed PoC.

The answers from the EMEA arrived well within the fixed three months time frame and did not require any additional meetings. "The scientific advice procedure with the EMEA went very smoothly," commented Dr. Jean-Francois Dufour-Lamartinie, Hybrigenics' Head of Clinical R&D. "This is further proof that our clinical development plan for inecalcitol in prostate cancer is sound and straightforward."

About prostate cancer

Prostate cancer is the most common type of cancer in men. The latest documented figures are forecasts of 192,300 new cases and 27,400 deaths from prostate cancer for 2009 in the United States of America, and estimates of 345,900 new cases and 87,400 deaths in 2006 for all of Europe.

At the time of diagnosis, if the cancer is localized to the prostate, it can be definitively cured by surgery and/or radiotherapy. If the cancer has already spread beyond the prostate gland, treatments with anti-hormonal drugs initially manage to keep it under control, in a so-called "hormone-dependent" stage. However, after several months or years, tumor growth resumes despite anti-hormonal treatment: the prostate cancer has then escaped into a "hormone-refractory" stage, for which Taxotere(R)- based chemotherapy is the standard of care. The worldwide drug market for prostate cancer is more than USD 3 billion per year, with an estimated 75/25 per cent split between hormone dependent/refractory stages, respectively.

About inecalcitol

Inecalcitol is an orally active agonist targeting the vitamin D receptor. The therapeutic rationale behind its development is to add its cytostatic potential to the established efficacy of the reference treatments of the two stages of prostate cancer: anti-hormonals (LH-RH agonists and anti-androgens) for the hormone-dependent stage and Taxotere(R)-based chemotherapy for the hormone-refractory stage.