Micell Technologies Announces First Patient Enrolled In Landmark Registration Trial of MiStent In Japan
DURHAM, N.C., November 28, 2016 — Micell Technologies, Inc. (Micell) announced enrollment of the first patient in DESSOLVE J: a prospective, randomized, balanced, controlled, double-blind, multi-center study comparing MiStent SES® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent) to XIENCE V Everolimus Eluting Coronary Stent System (Xience) in Japan. Shigeru Saito, M.D., Vice Director, Shonan Kamakura General Hospital and Director of Cardiology and Catheterization Laboratories, is the principal investigator.
DESSOLVE J is an all-comers trial with a primary endpoint of target lesion failure (TLF) comparing 12-month clinical outcomes between MiStent and Xience. Candidates for trial participation suffer from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, acute coronary syndromes and those who qualify for percutaneous coronary interventions. Enrollment is planned at approximately 10 clinical sites throughout Japan.
“We are pleased to enroll the first patient in this important study,” said Dr. Saito. “This study is a historic one for Japan. It will provide us with valuable insights into the potential benefits of MiStent’sunique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus.”
DESSOLVE J is intended to provide Japanese-specific data that is supportive of DESSOLVE III, an all-comers clinical study that includes 1,400 patients randomized to MiStent or Xience at 20 sites in Europe. DESSOLVE III completed enrollment in 2015. Following the completion of DESSOLVE J, Micell intends to file a pre-market approval application with Japan’s Pharmaceuticals and Medical Devices Agency for approval by its Ministry of Health, Labour, and Welfare.
Micell’s patented supercritical fluid technology allows for a rigorously controlled coating of the drug and polymer, whereby the drug is applied to a bare-metal stent in a dry powder, crystalline form. This preserves its morphology and optimizes its pharmacokinetic (distribution and absorption) profile. MiStent also leverages the benefits of a cobalt chromium coronary stent system — a state-of-the-art, ultra-thin-strut metallic stent that has demonstrated excellent deliverability, conformability and flexibility.
Arthur J. Benvenuto, Chairman and Chief Executive Officer of Micell said, “Cardiovascular disease poses a significant health risk in Japan and even with recent improvements in coronary artery disease treatment, additional advances in drug-eluting stents are still needed. Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement that could provide clinicians and patients worldwide with enhanced treatment options.”
MiStent is designed to optimize healing and clinical performance in patients with coronary artery disease. The rapidly absorbable coating of MiStent, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for extended local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents and improve long-term clinical outcomes.
EU approval of MiStent was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Micell also completed enrollment in December 2015 of DESSOLVE III, a 1,400 patient, 20 center, randomized clinical trial comparing MiStent to Xience Everolimus Eluting Coronary Stent System® (Xience).
DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center study comparing clinical outcomes between MiStent and Xience in a “real world, all-comers” patient population. Patients in the trial suffered from symptomatic coronary artery disease, including those with chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint for this trial is a non-inferiority comparison of target lesion failure (TLF) of the MiStent group versus the Xience group at 12 months post-procedure. The 12-month primary endpoint results for DESSOLVE III are expected to be released in the first half of 2017.
MiStent has received CE marking, but is not approved for sale in the United States.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as “anticipates,” “estimates,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of MiStent in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of, and expectations about, future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to, the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent in other jurisdictions; the successful development and commercialization of MiStent in Europe and other markets; the ability of MiStent to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release.
Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.
Contact for Micell Technologies
Arthur J. Benvenuto, Chairman & CEO