The Company previously announced positive initial safety, pharmacokinetic and pharmacodynamic results from three patients dosed with 15 mg/kg of batiraxcept in combination with cabozantinib in the Phase 1b portion of the trial.
#Ar938x specs trial#
Orphan drug designation is granted for medicines being developed for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union.īatiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC): Aravive plans to present new preliminary data from the Phase 1b portion of its Phase 1b/2 clinical trial of batiraxcept in ccRCC at the Society for Immunotherapy of Cancer Annual Meeting on November 13, 2021. In October, the European Commission granted orphan drug designation to batiraxcept for the treatment of PROC. The global, randomized, double-blind, placebo-controlled adaptive trial is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel versus paclitaxel alone. This provides an additional opportunity to be successful in both patient populations, regardless of the results of the interim analysis. The final analysis of the primary endpoint preserves the opportunity to evaluate the efficacy in patients who received bevacizumab prior to study entry, as well as those patients who never received bevacizumab. The interim analysis is being conducted to determine whether randomization will continue with all patients, regardless of prior bevacizumab treatment, or only with patients medically ineligible to receive bevacizumab or who chose not to receive bevacizumab. Aravive now expects to conduct the interim analysis in mid-2022. We remain optimistic about the broad potential of batiraxcept to improve the lives of people living with cancer.”īatiraxcept (AVB-500) in Platinum Resistant Ovarian Cancer (PROC): As a result of the evolving pandemic and other factors, the pace of enrollment in the registrational Phase 3 clinical trial of batiraxcept in PROC has been slower than originally anticipated. We look forward to presenting new preliminary data from our Phase 1b trial of batiraxcept in clear cell renal cell carcinoma at the upcoming Society for Immunotherapy of Cancer Annual Meeting in November. “Aravive is now advancing three clinical trials for life threatening cancers with unmet medical needs. “During the third quarter, we expanded our clinical oncology pipeline with the initiation of a Phase 1b trial of batiraxcept (AVB-500) for the treatment of pancreatic adenocarcinoma,” said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, today announced recent corporate updates and financial results for the third quarter ended September 30, 2021. New preliminary data from batiraxcept Phase 1b clinical trial in clear cell renal cell carcinoma to be presented at 2021 Society for Immunotherapy of Cancer Annual Meeting Orphan drug designation granted by European Commission to batiraxcept in platinum resistant ovarian cance r Aravive Reports Third Quarter 2021 Financial Results and Provides Corporate Updatesĭosed first patient in batiraxcept (formerly AVB-500) Phase 1b clinical trial in pancreatic adenocarcinoma
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