Hybrigenics Receives Positive Answers from EMEA
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Hybrigenics 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® 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."
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® 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."
