Elixir Medical Corporation Announces Excellent Nine Month Safety and Efficacy Results from the EXCELLA II Randomized Clinical Trial
Results Confirm Promise of Elixir's Novolimus Eluting Stent Program
SUNNYVALE, Calif.--(BUSINESS WIRE)--May 26, 2010 - Elixir Medical Corporation, a developer of product platforms combining state-of-the-art medical devices with advanced pharmaceuticals, announced today the superiority of the Elixir DESyne stent compared to the control Endeavor stent in the primary endpoint of the EXCELLA II randomized clinical trial.
The Elixir DESyne Stent is the first drug eluting stent with the thinnest durable polymer coating and a low drug dose to achieve excellent clinical outcomes as compared to the leading commercially available drug eluting stent systems. The DESyne stent elutes a novel macrocyclic lactone compound Novolimus.
Nine-month clinical, angiographic and IVUS results from the EXCELLA II randomized clinical trial evaluating the Elixir DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System was presented on behalf of the EXCELLA II investigators at EuroPCR by Alexandre Abizaid, M.D., Ph.D., from the Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, and co-principal investigator for the trial. The study was designed to enroll 210 patients in Europe, Australia, New Zealand and Brazil.
At nine months, the Elixir DESyne Stent demonstrated superiority (p<0.001) to the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.11 ± 0.32 and 0.63 ± 0.42 respectively). In a subset of patients who underwent intravascular ultrasound (IVUS), the Elixir DESyne Stent demonstrated a statistically significant reduction in neointimal inhibition with a percentage volume obstruction of 4.5% ± 5.1 compared to 20.9% ± 11.3 for the Endeavor Stent (p <0.001). Clinical events measured using the device oriented composite endpoint (DoCE) were lower for the DESyne stent compared to the Endeavor stent (2.9% and 5.6% respectively).
“The EXCELLA II study confirms the excellent 2-year results from the EXCELLA I trial and positions the Elixir DESyne Stent as a strong next generation DES product,” said Professor Alexandre Abizaid.
In addition, the Elixir DESyne stent demonstrated a statistically significant reduction in restenosis, a re-blockage in the stent, at nine months compared to Endeavor (1.4% and 7.6% respectively (p=0.037).
“The Elixir DESyne Coronary Stent System will be competitive with the best in class drug eluting stent systems,” added Professor Patrick W. Serruys, M.D., Ph.D. of the Thoraxcenter, Erasmus University Hospital, Rotterdam, The Netherlands, and principal investigator for the EXCELLA II trial.
“The excellent results from the EXCELLA II trial reinforces our enthusiasm for the Novolimus compound and the effectiveness of the Novolimus eluting coronary stent programs,” said Motasim Sirhan, chief executive officer of Elixir Medical. “These results also confirm that excellent clinical outcomes can be achieved with a design incorporating an ultra thin durable polymer and low drug dose,” continued Mr. Sirhan.
Elixir Medical Files for CE mark
Elixir Medical announced that the company submitted a CE mark application for the Elixir DESyne Novolimus Eluting Coronary Stent System in the first quarter of 2010.
About the EXCELLA II Clinical Trial
The EXCELLA II trial is a multi center, randomized, single blind, evaluation of the Elixir DESyne Novolimus Eluting Coronary Stent System compared to the control Endeavor Zotarolimus Eluting Coronary Stent System. The study was designed to enroll 210 patients from Europe, Australia, New Zealand and Brazil. The primary endpoint was in-stent late lumen loss assessed by quantitative coronary angiography (QCA) at nine months. Secondary endpoints of the study include: device-orientated composite endpoints and stent thrombosis rates at 30 days; 6, 9, 12, and 24 months; with annual clinical follow-up to 5 years. A subset of patients underwent intravascular ultrasound (IVUS) evaluation at 9 months.
About Elixir Medical's Product Pipeline
Elixir Medical is developing a wide range of drug and device platforms for vascular therapies. These include drug eluting stent systems with durable and bioabsorbable polymers, and fully bioabsorbable drug eluting stent systems.
The company utilizes the powerful macrocyclic lactone class of drugs, which have established safety and efficacy profiles. This family of drugs is the most widely used for drug eluting stent applications.
Novolimus, a metabolite of sirolimus, was developed internally by Elixir for use in site-specific therapies.
Elixir also has a license to Myolimus, a Novartis Pharma AG compound. The co-exclusive license grants Elixir worldwide rights to utilize the drug Myolimus with Elixir's vascular as well as other site-specific drug-delivery applications. In addition, Elixir has an exclusive worldwide license for use of Myolimus in fully biodegradable stents. The company is developing Myolimus-eluting systems with both durable and bioabsorbable polymers.
About Elixir Medical
Elixir Medical Corporation, a privately held company headquartered in Sunnyvale, California, develops products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide. The company's next-generation drug-eluting stent systems are designed to optimize local drug delivery to provide a safe and effective treatment for cardiovascular disease. For more information, visit www.elixirmedical.com.
Contact: Elixir Medical Corporation
Donna Collins, +1-408-636-2029
Posted: May 2010