FDA Approves Expansion of CeloNova's COBRA REDUCE Trial
October 26, 2017—CeloNova BioSciences, Inc. announced that the US Food and Drug Administration (FDA) approved expansion of the company's ongoing clinical trial of its Cobra Polyzene-F (PzF) nanocoated coronary stent (NCS) with 14-day dual antiplatelet therapy (DAPT) in complex patients, such as those who are at high bleeding risk. The COBRA REDUCE trial is a randomized control trial to assess 14-day DAPT after percutaneous coronary intervention (PCI).
According to CeloNova, the COBRA REDUCE trial is evaluating whether the Cobra PzF NCS—with its ultra-pure, ultra-thin Polyzene-F fluoropolymer—can optimize clinical outcomes with 14-day DAPT as compared to FDA-approved drug-eluting stents (DES) with 3 or 6 months of DAPT. The COBRA REDUCE trial will enroll up to 996 patients at 60 centers in the United States and Europe. Clinical data from CeloNova's pivotal PzF SHIELD trial demonstrated that the Cobra PzF NCS has very low risk for late ischemic events and low risk for clinically driven TLR with a short, 1-month DAPT minimum.
Cobra PzF NCS is approved for use in the United States, Europe, and the Middle East.
In the company's announcement, Robert Byrne, MD, co-lead investigator of the COBRA REDUCE trial, commented, "High bleeding-risk patients currently have limited stent treatment options available to them primarily due to the duration of DAPT required. The COBRA REDUCE trial aims to provide clinical insights into optimal stent selection and eliminate the compromise between the risk of bleeding or stent thrombosis." Dr. Byrne is Senior Physician at the German Heart Center in Munich, Germany.
Donald Cutlip, MD, Executive Director of the Baim Institute for Clinical Research (formerly Harvard Research Institute), added, "The highly anticipated COBRA REDUCE trial aims to expand upon the SHIELD study's exceptional clinical results and demonstrate Cobra PzF NCS as a safe and effective stent option when combined with 14 days of DAPT. I have many patients at high risk of bleeding or who have difficulty maintaining even short-term DAPT regimens. Being able to provide a therapy that is personalized to the patient is of great clinical value."
The company advised that the Cobra PzF NCS device and the COBRA REDUCE trial will be featured in several sessions at the TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado.