Enrollment in Phase III study increases drastically following inVentiv dismissal

By Zachary Brennan contact

- Last updated on GMT

Enrollment in study increases drastically following inVentiv dismissal

Related tags: Clinical trial, Inventiv

Cancer drug developer CEL-SCI announced Tuesday that since dropping CRO inVentiv Clinical back in 2013, patient enrollment in the trial run by its two new CRO partners – Aptiv Solutions and Ergomed -- has increased more than eight fold.

Over the past three months CEL-SCI enrolled 58 patients, including 20 in November, with advanced primary head and neck cancer into its global Phase III trial for its lead investigational immunotherapy Multikine (Leukocyte Interleukin, Injection).  

CEL-SCI CEO Geert Kersten said in a statement: “During 2013 we had to dismiss Inventiv Clinical, LLC, the prior clinical research organization (CRO) running our Phase III study, for, among other things, lack of patient enrollment in the study…As can be clearly seen from the rapid increase in enrollment under the new companies, the study is now proceeding quite well.  Yet we are working to further increase enrollment with the aim of fully enrolling all patients by the end of 2015. Almost every month we are adding new clinical centers to the study​.”  

Background​ 

inVentiv and CEL-SCI are locked in a legal battle, with CEL-SCI claiming inVentiv breached their contract and committed trial fraud. 

The latest development occurred in August when a judge dismissed inVentiv’s motion to dismiss the trial, a company spokeswoman told us. CEL-SCI is seeking $50m in damages from the lawsuit. 

The spokeswoman also said that the trial date is expected to be in Q3 of 2015 and that CEL-SCI’s CEO cannot comment further on the trial. 

InVentiv previously said in a statement that the allegations amount to "nothing more than an attempt to avoid paying an outstanding debt. Cel-Sci's legal claims are meritless, and we will vigorously defend against the baseless allegations​." 

Studies​ 

The objective of the Phase III study is to demonstrate a 10% improvement in overall survival of the subjects treated with Multikine treatment regimen as compared to subjects treated with current standard of care. 

Additional clinical indications for Multikine under investigation include cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase I trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase I trial in conjunction with the US Navy. 

CEL-SCI also entered into two other co-development agreements with CRO Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are HIV/HPV co-infected and for peri-anal warts in men and women who are HIV/HPV co-infected.

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