americanpharmaceuticalreviewDecember 11, 2020
Tag: PhoenixMD , TNBC , PMD-026
Phoenix Molecular Designs (PhoenixMD) announced the first patient has been dosed in their Phase 1b clinical trial of PMD-026. This RSK targeting trial is a first of its kind in the battle to combat the most aggressive subtype of breast cancer, known as Triple Negative Breast Cancer (TNBC). This patented small molecule, PMD-026, positions PhoenixMD in the lead to fill an unmet medical need as an effective treatment for this serious medical condition.
This new trial comes at a critical time as, to date, durable treatment options for TNBC have been extremely limited. PhoenixMD's lead asset, PMD-026, is the first purpose-built investigational drug specifically designed for TNBC. The company's goal is to develop a therapy to treat TNBC that offers advantages over current approaches by taking aim at RSK, which is an entirely new drug target. PMD-026 is different from other therapies in that it is an oral capsule that can be taken at home rather than requiring an in-clinic or in-hospital administration. In addition, based on the data obtained in their Phase 1 clinical trial, PMD-026 was well-tolerated without hair loss or peripheral neuropathy, which are side effects of a number of other chemotherapy drugs.
"Our mission is to improve the outcome for TNBC patients. This is a pivotal time for PhoenixMD; our extensive research to finding a path forward has reached the next important clinical milestone. PhoenixMD continues to aggressively pursue the clinical development of PMD-026 in an accelerated timeline while always ensuring that patient care is first and foremost in every decision that we make. As we begin our Phase 1b clinical trial, I am excited about the opportunity to bring this therapy, that uniquely targets the RSK pathway, to women with TNBC who participate in our clinical trial and who so desperately need help not provided by existing treatment options," said Sandra Dunn, Ph.D., Chief Executive Officer, PhoenixMD."
Initially, 20 TNBC patients will be enrolled in this Phase 1b expansion trial. As with the Phase 1 trial, this new trial will be conducted at leading medical centers across the United States.
"Today's announcement builds on PhoenixMD's success with our Phase 1 clinical trial in metastatic cancer patients, which PhoenixMD completed in September of 2020," said F. Andrew Dorr, M.D., Chief Medical Officer, PhoenixMD. "At this pivotal time, I would like to recognize the PhoenixMD and SciQuus Oncology teams who have worked so diligently throughout the COVID-19 pandemic and the Phase 1 clinical trial. We are ready to meet the challenges and successes ahead in this next phase. I firmly believe that every step we take is a step closer towards finding a successful treatment for TNBC."
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