The trial will determine the tolerable dose of Pidnarulex in solid tumour patients with BRCA1/2, PALB2 and HR gene mutations.
Senhwa doses first subject in trial of Pidnarulex for solid tumours.
Senhwa Biosciences has dosed the first subject in a clinical trial of Pidnarulex as a potential treatment for solid tumours with Homologous Recombination (HR) gene mutations.
The first patient in the Phase Ib trial was dosed at the Princess Margaret Cancer Centre in Toronto, Canada.
Pidnarulex is a synthetically derived small molecule and is supplied as a lyophilised drug with intravenous administration.
The open-label, multicentre Phase Ib expansion study in the US and Canada is designed to find a tolerable dose of Pidnarulex in subjects with selected solid tumours with BRCA1/2, PALB2 and other HR gene mutations.
Furthermore, the selected dose will be utilised to conduct further Phase II trials of Pidnarulex.
Senhwa Biosciences chief medical officer Dr John Soong said: “We are very excited to begin enrolment in our Phase Ib clinical trial for evaluating Pidnarulex in patients with BRCA1/2, PALB2 and other homologous recombination gene mutations.
“This is an important milestone and marks a new paradigm in the treatment of cancers with specific pathogenic mutations.”
In a prior Phase I trial, Pidnarulex showed to have clinically significant and durable benefits in patients with specific tumour biomarkers such as BRCA1/2 and PALB2 mutations and platinum and other chemotherapeutic-resistant biomarkers.
September 13th, 2021