CEL-SCI Corporation (CVM) Hires Two CROs; Multikine Phase III Trial Being Expanded
On April 23, 2013, CEL-SCI Corporation announced that the company hired two clinical research organizations, Aptiv Solutions and Ergomed, to manage the Multikine phase III study. Both CROs will help CEL-SCI expand the trial by 60 to 80 clinical sites globally. Aptiv Solutions and Ergomed have replaced the CRO currently managing the study.
Under a co-development agreement, Ergomed, which will be responsible for most of the new patient enrollment, will contribute up to $10 million towards the study. Ergomed will perform clinical services in exchange for milestone and royalty payments (single digit %) up to a specified maximum amount.
To date, the phase III trial has enrolled 117 patients at 39 centers in eight countries, including three centers in Israel, and nine centers in Taiwan.
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.
