PharmaMar (MSE:PHM) has announced the start of an open-label multi-centre two-stage Phase II trial with the anti-tumour drug PM184. The trial will be conducted in 10 European clinical centres and will include 106 patients. The trial will focus on patients with hormone-receptor positive, HER2-negative, locally advanced and/or metastatic breast cancer, who have experienced progression following earlier treatment with anthracyclines and taxanes. The second stage of this Phase II trial will be randomised vs. investigator's best choice, to assess the efficacy and safety of PM184.
The primary endpoint is to evaluate the efficacy of PM184 with regard to four-month progression free survival (PFS). Secondary endpoints include analysing a more convenient administration pattern for PM184, overall survival, median PFS, overall response, and response duration measured in accordance with RECIST (Response Evaluation Criteria In Solid Tumors) Guideline Version 1.1. The trial will also assess safety and pharmacological profiles in the target population, and perform pharmacogenetic analyses to examine inter-patient variations in the transformation and elimination of PM184, together with pharmacogenomic studies that will contribute to identifying predictors of the response to the drug.
"We are encouraged that PM184 is now progressing into Phase II clinical trial which represents a significant step forward by PharmaMar in addressing breast cancer, one of the most common cancers," said Arturo Soto, Director of Clinical Development at PharmaMar's Oncology Unit. "PM184 is a compound of marine origin that inhibits the microtubular function and targets a protein called tubulin in a novel way, and we are very looking forward to the results," he added.