Medinol and Ariad Pharmaceuticals (NSDQ:ARIA) said today that they’re planning to launch a pair of clinical trials examining Medinol’s NIRsupreme drug-eluting coronary stent using Ariad’s ridaforolimus drug.
The 1st study, called the Bionics trial, will compare the NIRsupreme stent with Medtronic‘s (NYSE:MDT) Resolute zotarolimus-eluting stent in 1,900 patients with coronary artery disease. The 2nd study, Nireus, aims to prove angiographic non-inferiority to the Resolute stent in 300 CAD patients, according to a press release.
Initiation of the trials triggered a nearly $3.8 million milestone payment for Ariad from Medinol, which licensed ridaforolimus from Ariad in 2005, according to the release. Another $34.8 million is on the in line in potential milestones, the companies said.
Medinol said it’s planning to use the data from the studies to back an application for an investigational device exemption from the FDA.
"We are proud and excited to initiate the Bionics and Nireus clinical trials," Medinol’s chief scientific officer Yoram Richter said in prepared remarks. "NIRsupreme, the first ever elastomer-based DES, is the outcome of meticulous research towards uniform, controlled drug release. We believe that this is the evolution that interventional cardiologists have been waiting for. Medinol is privileged to cooperate with ARIAD, a leading drug developer, and has high expectations for this partnership."
"We are pleased to have one of the most innovative and successful medical device companies advance the development and potential commercialization of drug-delivery stents incorporating ridaforolimus," added Timothy Clackson, Ariad’s chief scientific officer. "We believe that Medinol has developed a unique elastomeric formulation and stent platform, and we are delighted by the value created through this successful long-term collaboration with a true innovator."
Ridaforolimus, a small-molecule inhibitor of the protein mTOR, blocks the proliferation and migration of vascular smooth muscle cells, according to the release. It’s an analog of sirolimus, a drug used in early drug-eluting stents including the Cypher device made by Johnson & Johnson‘s (NYSE:JNJ) Cordis subsidiary.
In March 2012, an FDA advisory panel recommended against approval for ridaforolimus in treating soft-tissue and bone sarcomas, branded as Taltorvic under a license taken out by pharma giant Merck (NYSE:MRK), which still owns the rights to oncology applications for the drug, the Boston Business Journal reported.