Sirolimus News and Research

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Erasmus Medical Center Professor to present LEADERS trial result at TCT symposium

Three-year data from the prospective, randomized LEADERS trial demonstrate the equivalence of a biolimus A9-eluting stent with a biodegradable polymer vs. a sirolimus-eluting stent with a durable polymer. The results will be presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

23 Sep 2010

Biodegradable polymers represent future of stent design

Three-year data demonstrated that satisfactory clinical and safety outcomes of sirolimus eluting stents with a biodegradable polymer were sustained in a real world setting. The results were presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

21 Sep 2010

Elixir Medical commences enrollment in EXCELLA BD trial for DESyne BD Novolimus Eluting CSS

Elixir Medical Corporation, a developer of product platforms that combine innovative medical devices with potent pharmaceuticals for site-specific therapies, announced the initiation of patient enrollment in the EXCELLA BD Randomized Clinical Trial designed to evaluate Elixir's next generation Novolimus Eluting Coronary Stent System (CSS) with bioabsorbable coating, the Elixir DESyne BD Novolimus Eluting CSS.

18 Sep 2010

Late breaking clinical trials in interventional cardiovascular medicine to be presented at TCT 2010

Clinical trials in a variety of areas within interventional cardiovascular medicine that will be presented at TCT 2010 will directly affect the way that people with cardiovascular disease are treated. Breakthroughs in science and medical research, presented exclusively at TCT, will lead to new treatments that are minimally invasive and involve shorter recovery times. Among the topics being covered are stenting in the femoral artery, polymer-free drug-eluting stents, valves and drug-eluting balloons used in angioplasty.

8 Sep 2010

Data from ESC confirms reduction in adverse events with CYPHER Stent

Additional Analysis of 18 Month Data of the SORT OUT III Trial Provides Detail on Safety and Efficacy Outcomes in Patients With Diabetes, Acute Coronary Syndrome, or Treatment of Multiple Lesions

3 Sep 2010

Iroko Cardio International Sàrl announces data on HDB dosing of tirofiban, abciximab in interventional cardiology

Iroko Cardio International Sàrl announces long-term, three-year, mortality data from the Phase III, open label, multi-national study comparing high-dose bolus (HDB) dosing of AGGRASTAT(tirofiban) (25mcg/kg bolus followed by a 0.15mcg/kg/min infusion for 18-24 hours) vs. ReoPro (abciximab) in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), presented at the 2010 European Society of Cardiology Meeting in Stockholm, Sweden.

3 Sep 2010

CORDIS reports positive results from 10-year follow-up of CYPHER Sirolimus-eluting coronary stent study

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, announced today at European Society of Cardiology in Stockholm that the results of follow-up tests undertaken ten years after the first patient was treated with a CYPHER(R) Sirolimus-eluting coronary stent have proven outstanding long-term efficacy and safety and were published earlier this year in "JACC: Cardiovascular Interventions".

31 Aug 2010

LESSON I trial provides evidence of benefits of everolimus-eluting stent over sirolimus-eluting stent

Results from the LESSON I trial presented today provide preliminary evidence for the therapeutic benefit of the newer generation everolimus-eluting stent over the previous gold standard, the early generation sirolimus-eluting stent. Moreover, LESSON I provides evidence that the formation of blood clots (stent thrombosis) - the principal shortcoming of early generation drug-eluting stents - may be diminished with the newer generation everolimus-eluting stent.

31 Aug 2010

CRF announces additional featured trials to be presented at Transcatheter Cardiovascular Therapeutics 2010

The Cardiovascular Research Foundation has announced that in addition to the previously announced late breaking clinical trials and first reports, a series of additional featured trials will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 scientific symposium. These trials will focus on a wide range of significant topics in interventional cardiovascular medicine. TCT 2010 will take place September 21 - 25 in Washington, DC.

13 Aug 2010

FDA accepts to review sNDA for SPRYCEL for treating adult patients with CML

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for SPRYCEL (dasatinib) for the treatment of adult patients with newly diagnosed chronic myeloid leukemia in chronic phase.

12 Jul 2010

European Congress of Nephrology unveils results of various clinical trials

The 47th ERA-EDTA/DGfN congress in Munich has been the setting for a wide range of new clinical data. The results of the following clinical trials were presented at "Late-Breaking Clinical Trials Sessions."

30 Jun 2010

Merck proposes to initiate Phase II proof-of-concept clinical study of posaconazole for chronic Chagas disease

Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection.

24 Jun 2010

Four-year follow-up results from SPRYCEL Phase 3 study in CML-CP presented at ASCO

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced four-year follow-up results from a Phase 3 randomized, open-label, dose-optimization study of SPRYCEL® (dasatinib) in chronic-phase chronic myeloid leukemia (CML-CP) patients resistant or intolerant to Gleevec®* (imatinib mesylate). At four years, for all patients administered SPRYCEL 100 mg once daily, overall survival was 82% (95% CI: 76%-88%) and progression-free survival was 66% (95% CI: 57%-74%).

9 Jun 2010

NEVO Sirolimus-eluting Coronary Stent demonstrates safety and efficacy outcomes at 12 months

At 12 months the NEVO™ Sirolimus-eluting Coronary Stent has continued to demonstrate excellent safety and efficacy outcomes compared to Taxus® Liberte® according to new data presented today from the NEVO™ RES-I clinical trial. These results were presented as a late breaking trial at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine.

26 May 2010

Immunosuppressive drug sirolimus improves kidney health of patients with ADPKD: Study

The immunosuppressive drug sirolimus considerably improves the kidney health of patients with autosomal dominant polycystic kidney disease, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology.

14 May 2010

Drug-releasing stents do not result in fewer deaths or subsequent heart attacks after angioplasty

Drug-releasing stents are more effective than bare metal stents at keeping a blocked artery open after angioplasty, but the difference does not result in fewer deaths or subsequent heart attacks after the procedure, according to a review of recent studies.

12 May 2010

Zilver PTX Drug-Eluting Peripheral Stent safe and effective for treating SFA lesions

Patients treated with the Zilver® PTX™ Drug-Eluting Peripheral Stent maintained clinical improvement at two years, according to interim results from the Zilver® PTX™ Global Registry presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd Annual Scientific Sessions.

10 May 2010

Watson Laboratories sued in connection with filing of ANDA for generic version of Rapamune tablets

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Pfizer Inc. and Wyeth Pharmaceuticals Inc. in connection with the filing of Watson's Abbreviated New Drug Application for sirolimus tablets in the 1 mg and 2 mg strengths.

29 Apr 2010

SurModics reports second-quarter GAAP revenue of $18.4 million, up 6% sequentially

SurModics, Inc., a leading provider of drug delivery and surface modification technologies to the healthcare industry, today reported financial results for the second quarter ended March 31, 2010.