On March 4, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that it has enrolled the first patient in its European Phase 2 clinical trial of IXEMPRA (ixabepilone) for the treatment of metastatic breast cancer (Press release, Allarity Therapeutics, MAR 4, 2021, View Source [SID1234576114]).
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The U.S. Food and Drug Administration (FDA) approved IXEMPRA, a microtubulin inhibitor, in 2007 for the treatment of metastatic breast cancer. Allarity holds exclusive European option rights to IXEMPRA from the pharmaceutical company R-Pharm U.S., LLC, which previously acquired global rights to the drug from Bristol-Myers Squibb (BMS). Allarity has previously developed and validated a Drug Response Predictor (DRP) companion diagnostic specific for the drug.
"We are pleased to announce the enrollment of the first patient in our DRP-guided Phase 2 clinical trial for IXEMPRA, one of our prioritized pipeline programs. Phase 2 development of this asset in the European Union (EU) positions us to advance the drug toward a registrational approval and commercialization in this major oncology market, a necessary step for making it available to individuals living with metastatic breast cancer in Europe," commented Steve R. Carchedi, CEO of Allarity Therapeutics. "We are confident that our Phase 2 study will prove the merits of this drug, together with its DRP companion diagnostic, further clinically validating our DRP biomarker technology."
Allarity is currently conducting a DRP-guided Phase 2 clinical trial to evaluate IXEMPRA for the treatment of third-line metastatic breast cancer, with numerous trial sites planned in Europe, including Belgium, England, Denmark, Finland, Poland and Germany. The Company’s protocol plans for an enrollment target of 60 IXEMPRA DRP-selected patients. By using DRP for patient selection, Allarity aims to provide a superior clinical benefit to patients receiving IXEMPRA, as compared to historical clinical data from breast cancer patients treated with IXEMPRA but not selected with DRP. Principal Investigator Guy Jerusalem, M.D., Ph.D., Head of Medical Oncology and Director of the Breast Clinic at the University Hospital Center in Liege, Belgium, enrolled the first DRP-selected patient.
"I am pleased to see the first patient enrolled in our European Phase 2 trial for IXEMPRA," added Marie Foegh, M.D., D.Sc., CMO of Allarity Therapeutics. "We look forward to further evaluating the clinical and therapeutic value of our IXEMPRA DRP companion diagnostic, and to providing individuals with metastatic breast cancer another therapeutic option through our personalized medicine approach."
About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug specific DRP to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific drug. By screening patients before treatment, the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and prior clinical trial outcomes. DRP is based on messenger RNA from the patient’s biopsies. DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in nearly 40 clinical studies that were examined, including an ongoing, prospective Phase 2 trial. The DRP platform can be used in all cancer types and is patented for more than 70 anti-cancer drugs.