Phoenix Molecular Designs (PhoenixMD) has concluded subject enrolment and dosing in the Phase I/Ib monotherapy trial of its PMD-026 pill being developed to potentially treat breast cancer.
An orally available first Ribosomal S6 Kinase (RSK) inhibitor, PMD-026 was developed to potentially attack hard to treat cancers such as triple-negative breast cancer (TNBC).
The trial was carried out at nine cancer centres in the US and dosed 41 patients.
These subjects were given two daily doses of PMD-026.
To establish safety and tolerability and identify the recommended Phase II dosing regimen of PMD-026 in study subjects were the primary endpoints of the trial.
A major secondary endpoint was to evaluate if the level of RSK2 expression in tumours suggests better outcomes in patients.
With the conclusion of enrolment in the trial, the company intends to progress PMD-026 into Phase II combination trials for TNBC and hormone-positive breast cancer.
Phoenix Molecular Designs founder and CEO Dr Sandra Dunn said: “The completion of patient enrolment in our Phase Ib clinical trial brings us closer to our ultimate goal of developing a therapeutic that will bring a clinically meaningful improvement to the lives of thousands of people living with TNBC.
“We are making hope a reality as the PhoenixMD team has developed the first uniquely-engineered kinase inhibitor for TNBC based on RSK2 as a biomarker for patient selection.”
Phase I results showed that PMD-026 demonstrated to be well-tolerated in patients with breast cancer and could hinder tumour growth for up to five months.
According to preclinical data, PMD-026 was found to possess the potential to become a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitisation for several refractory cancers.