DGAP-Adhoc Heidelberg Pharma AG: FDA Allows Heidelberg Pharma to Start a Phase I/IIa Clinical Trial with ATAC Candidate HDP-101
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DGAP-Ad-hoc: Heidelberg Pharma AG / Key word(s): Study Ad hoc announcement - Inside information pursuant to Article 17 MAR |
FDA Allows Heidelberg Pharma to Start a Phase I/IIa Clinical Trial with ATAC Candidate HDP-101
Ladenburg, Germany, 4 February 2021 - Heidelberg Pharma AG (FSE: HPHA) today announced that the US Food and Drug Administration (FDA) has informed the company it is safe to proceed with the Phase I/IIa study with the BCMA Antibody Targeted Amanitin Conjugate, HDP-101 that was submitted under its US IND. The study will evaluate HDP-101 for the treatment of multiple myeloma, a blood cancer with high unmet medical need.
The first part of the trial is a Phase I dose escalation study to determine the maximum tolerated dose of HDP-101. The findings from Phase I will be used to establish the dose for the Phase IIa portion of the trial, the primary objective of which is to assess the preliminary anti-tumor activity of HDP-101.
The two parts of the open-label, multicenter Phase I/IIa study will enroll up to 36 and 30 patients, respectively. Patients in the Phase IIa part will be stratified based on their 17p deletion status. Preclinical data show that Amanitin has the potential to be especially effective against tumors that have changed due to so-called 17p deletion mutations to bypass a special mechanism of cell protection. Patients with such a deletion usually show a poorer response to standard therapies and have a significantly worse prognosis. The Phase IIa part of the trial is intended to evaluate not only the efficacy of HDP-101 in multiple myeloma patients, but also the clinical relevance of the 17p deletion.
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