ARIAD Pharmaceuticals, Inc. and Medinol, a global leader in the field of stents and stenting systems, have initiated two registration trials of Medinol's NIRsupreme Ridaforolimus-Eluting Coronary Stent System incorporating ARIAD's mTOR inhibitor, ridaforolimus. 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.
ARIAD licensed ridaforolimus to Medinol for use in drug-eluting stents in 2005. Drug-eluting stents (DES) are now implanted in over 500,000 patients yearly in the United States.
The commencement of patient enrollment in Medinol's clinical trials, along with the submission of an investigational device exemption with the US Food and Drug Administration, 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.
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.
"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," said Timothy P Clackson, president of research and development and chief scientific officer at ARIAD. "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."
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. These rights are separate from those licensed to Merck for use of ridaforolimus in oncology.
"We are proud and excited to initiate the BIONICS and NIREUS clinical trials," said Yoram Richter, Ph.D., chief scientific officer at Medinol. "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," Dr Richter concluded.
Ridaforolimus is an investigational targeted and potent 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 for oncology.
ARIAD Pharmaceuticals, Inc., is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines.