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).

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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.

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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.