Date: 2014-01-14
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trials
Company: Medinol (Israel) Ariad Pharmaceuticals (USA - MA)
Product: NIRsupreme™ ridaforolimus-eluting stent
Action
mechanism: Ridaforolimus is a targeted small-molecule inhibitor of the protein mTOR, a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT and PTEN, known to be important to malignancy. Ridaforolimus also blocks the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and reblockage of injured arteries, and is an analog of sirolimus, another mTOR inhibitor that has been approved for use on drug-eluting stents. Ridaforolimus is currently licensed to Medinol for medical devices and to Merck&Co for oncology.
Disease: coronary artery disease
Therapeutic area: Cardiovascular diseases
Country: USA, Europe , Israel and Canada
Trial
details: The two NIRsupreme clinical trials are randomized, single-blind, global studies taking place in the United States , Europe , Israel and Canada and will enroll approximately 2,200 patients with coronary artery disease. The BIONICS trial aims to show that the NIRsupreme stent is comparable (non-inferior) to a comparator drug-eluting stent with the primary endpoint of coronary target lesion failure (a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization) at 12 months. This trial is expected to enroll approximately 1,900 patients. The NIREUS trial aims to demonstrate angiographic non-inferiority of the NIRsupreme stent to a comparator stent and has a primary endpoint of late loss in lumen diameter within the stent determined by coronary angiography at six months. This trial is expected to enroll approximately 300 patients.
Latest
news: * On January 14, 2014, Ariad Pharmaceuticals and Medinol have announced the initiation of two registration trials of Medinol\'s NIRsupreme™ ridaforolimus-eluting stent system incorporating Ariad\'s mTOR inhibitor, ridaforolimus. Ariad licensed ridaforolimus to Medinol for use in drug-eluting stents in 2005. The commencement of patient enrollment in Medinol\'s clinical trials, along with the submission of an investigational device exemption with the FDA , triggers milestone payments to Ariad of $3.75 million , with the potential for additional regulatory, clinical and sales milestones, as well as royalties on product sales.
Ariad entered into a non-exclusive agreement with Medinol to develop and commercialize stents and other medical devices to deliver ridaforolimus to prevent reblockage of injured vessels following stent-assisted angioplasty. Ariad is eligible to receive additional regulatory, clinical and commercial milestones of up to $34.75 million , if two products are developed, plus royalties on worldwide product sales. Ariad is responsible for supplying ridaforolimus to Medinol , and Medinol is responsible for the development and commercialization of the medical devices delivering ridaforolimus.
