Novotech Selected for Phase I Oncology Study
The Cantrixil Phase I study will be weighted towards ovarian cancer patients with the selection of a gynecological oncology site.
US-Australian drug discovery company, Novogen Limited announced it has engaged Novotech, based in Australia, as its CRO to conduct its Phase I clinical study for the drug candidate, Cantrixil, which will commence in 2016. The Cantrixil Phase I study will be weighted towards ovarian cancer patients with the selection of a gynecological oncology site. However, patients with other cancer types will also be eligible to enroll in this first study since early preclinical data suggests the drug candidate may benefit patients with a range of cancer types.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
