Hybrigenics Meets with EMEA on Further Clinical Development of inecalcitol
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Hybrigenics, a bio-pharmaceutical company with a focus on research and development of new cancer treatments and specialized in protein interactions, announces its meeting with the European Medicines Agency (EMEA) in London to launch the formal process for official scientific advice on the clinical efficacy plan for inecalcitol in hormone-refractory prostate cancer patients.
Hybrigenics has outlined the design of a Phase IIb clinical trial of high doses of oral inecalcitol in addition to intravenous cycles of Taxotere®. The objective of the trial is to achieve "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 (87 percent) currently observed among patients in the ongoing Phase IIa dose-escalation tolerance study of inecalcitol provided the foundation for the proposed PoC.
The meeting with the EMEA marks the official start to the procedure of obtaining scientific advice on the technical aspects of study protocol. This will result in recommendations from the EMEA within approximately three months.
"Both the pre-IND meeting with the United States Food and Drug Administration (FDA) in the Spring, and now this pre-submission meeting with the EMEA, aim at putting inecalcitol on good regulatory tracks for further development," commented Remi Delansorne, Hybrigenics' CEO.
Hybrigenics has outlined the design of a Phase IIb clinical trial of high doses of oral inecalcitol in addition to intravenous cycles of Taxotere®. The objective of the trial is to achieve "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 (87 percent) currently observed among patients in the ongoing Phase IIa dose-escalation tolerance study of inecalcitol provided the foundation for the proposed PoC.
The meeting with the EMEA marks the official start to the procedure of obtaining scientific advice on the technical aspects of study protocol. This will result in recommendations from the EMEA within approximately three months.
"Both the pre-IND meeting with the United States Food and Drug Administration (FDA) in the Spring, and now this pre-submission meeting with the EMEA, aim at putting inecalcitol on good regulatory tracks for further development," commented Remi Delansorne, Hybrigenics' CEO.
