According to Renova Therapeutics, selecting a contract research organization (CRO) is a “key milestone” following a completed end-of-phase II meeting with the US Food and Drug Administration (FDA) for its lead gene therapy product candidate, RT-100, last year.
David Bowser, Worldwide Clinical Trials, executive vice president and general manager for global clinical development, told us the company is currently working closely with Renova on study start up and confirming the complete study schedule, as the CRO was contracted to support the full scope of the study.
“We treat all customer relationships as long-term partnerships and are appropriately staffed to manage this study. However, we’re always looking to add talented and passionate people to our team to help us with projects like this one,” he added.
Worldwide Clinical Trials will work in collaboration with Renova’s Dr. Richard McCloskey, MD, executive vice president of clinical development, and Jennifer Spinella, senior vice president of regulatory affairs and quality assurance, throughout the Phase III study.
The trial is set to start in the second half of 2017, with 536 patients across 60 US-based medical centers.
Bellerophon Therapeutics
In related news, Bellerophon Therapeutics has announced confirmation from the FDA of its acceptance of all modifications proposed by the company to its Phase III program for INOpulse in Pulmonary Arterial Hypertension (PAH).
Worldwide Clinical Trials is Bellerophon’s strategic CRO partner for the INOpulse PAH program.
According to the CRO, it will be providing a range of services for the modified Phase III study, including regulatory affairs, site monitoring, project management, safety and medical monitoring support, and trial master file services.
The protocol changes are expected to reduce time to market for INOpulse by approximately two years.