Case Study

MedicINova Changes CROs During Phase II Asthma Trial

Source: Synteract

SynteractHCR, Inc. was sought out by sponsor MediciNova, a publicly traded biopharmaceutical company headquartered in San Diego, for assistance on a Phase 2 asthma trial, MN-221 Cl-007: A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MN-221 in adults with acute exacerbations of asthma. MediciNova initially chose a global CRO for this study, not realizing that SynteractHCR had international capabilities. However, according to Dr. Kazuko Matsuda, chief medical officer, and Dr. Kirk Johnson, chief scientific officer, the previous CRO did not proactively handle the study and a change was needed:

“As the MN-221-CL-007 trial was ongoing, we decided that certain issues with the CRO warranted reconsideration of our initial choice. Based on our positive experiences with SynteractHCR on previous trials, we decided to solicit their work on this trial. This turned out to be a wise decision as SynteractHCR worked closely with us to assume the CRO’s responsibilities with diligence, reliability and professionalism from each of their respective departments. The trial ended in Spring, 2012 and we were highly satisfied with the quality of work, especially with respect to the biostatistics department’s efforts in the data analysis, and positive working relationship with the SynteractHCR team.”