|Medtronic Reporting Stents Met Primary Endpoint; EntreMed's ENMD-2076 Begins Phase 2 Trial|
|By Staff and Wire Reports|
|Thursday, 31 October 2013 22:35|
According to findings from several studies presented at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, patients with coronary artery disease who received an Endeavor or Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) and subsequently interrupted their dual antiplatelet therapy (DAPT) earlier than current guidelines recommend experienced no increased risk of stent thrombosis at one year or more of follow up. Both devices elute the drug zotarolimus to reduce the risk of restenosis.
Presented today during the late-breaking clinical trials session and published concurrently by the Journal of the American Medical Association (JAMA), the OPTIMIZE study compared one-year outcomes in patients who received the Endeavor drug-eluting stent (DES) and stayed on DAPT for either three or 12 months. It is the largest prospectively designed, multicenter randomized controlled trial to evaluate the clinical implications of DAPT discontinuation after three months as compared with standard 12 months of DAPT following implantation of any single DES.
Rigorously conducted at 33 medical centers in Brazil, the OPTIMIZE (OPTIMIzed Duration of Clopidogrel Therapy Following Treatment with the E-ZES in Real-World Clinical Practice) study enrolled 3,119 patients requiring percutaneous coronary intervention (PCI) who received an Endeavor DES and were then equally randomized to either three months (N=1,563) or 12 months (N=1,556) of DAPT. The primary endpoint was net adverse clinical and cerebral events (NACCE, a composite of all-cause death, myocardial infarction, stroke or major bleeding) at one year. The main exclusion criteria were primary or rescue PCI for STEMI (ST-segment elevation myocardial infarction), lesion located in a saphenous vein graft (SVG), and previous PCI with DES.
The study met its primary endpoint by showing noninferiority in NACCE rates at one year between patients treated with three months versus 12 months of DAPT (6.0 percent vs. 5.8 percent, p noninferiority=0.002) after implantation of an Endeavor DES. In addition, there was no statistically significant increase in the occurrence of ARC (Academic Research Consortium) definite or probable stent thrombosis at one year (0.8% with three months of DAPT versus 0.8% with 12 months of DAPT, p=not significant).
"Our findings show that stopping DAPT after three or 12 months following implantation of the Endeavor DES made no difference in relation to NAACE and stent thrombosis at one year of follow up," said Fausto Feres, M.D., Ph.D., an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil, and principal investigator of the OPTIMIZE study. "More generally, they also support the notion that stent selection has a bearing on safety outcomes. From the results of the OPTIMIZE study and other new data from the RESOLUTE clinical program that were presented earlier this week, a reevaluation of DAPT duration following implantation of Medtronic's zotarolimus-eluting stents is probably warranted."
Further reinforcing the safety profile of zotarolimus-eluting stents, the latest data on the Resolute DES from two analyses presented at TCT also demonstrated favorable clinical outcomes in patients who interrupted their dual antiplatelet therapy early.
Presented by Ajay Kirtane, M.D., chief academic officer and director of the interventional cardiology fellowship program at NewYork-Presbyterian Hospital/Columbia University Medical Center, an analysis of nearly 5,000 patients who received a Resolute DES showed that DAPT interruption after one month of device implantation posed no increased risk of stent thrombosis at three years of follow-up. Of the 684 patients who interrupted their DAPT after one month and before one year, none (0.0 percent) experienced a stent thrombosis out to three years.
Additionally, Deepak Bhatt M.D., M.P.H., chief of cardiology at the VA Boston Healthcare System, director of the Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and the VA Boston Healthcare System, and professor of medicine at Harvard Medical School, presented a related analysis on an expanded patient pool of nearly 7,000 patients who received a Resolute DES. Consistent with Dr. Kirtane's findings, the risk of stent thrombosis at one year did not increase for those patients who interrupted their DAPT after one month compared to those who did not.
Dual antiplatelet therapy guidelines for patients who receive a drug-eluting stent differ by geographic region, but generally recommend daily compliance for six to 12 months. The applicable guidelines are referenced in the country-specific labeling for each device. Medtronic continues to support adherence to all guidelines related to stenting.
Consistent with ACC/AHA/SCAI guidelines for PCI, the U.S. labeling for the Resolute Integrity DES recommends 12 months of DAPT. Earlier this year Medtronic received approval to update the Resolute Integrity stent's CE mark labeling to reflect the fact that DAPT interruption or discontinuation after one month posed "low and no increased risk" of stent thrombosis at one year.
Like the Endeavor and Resolute drug-eluting stents, the Resolute Integrity DES also elutes the drug zotarolimus. All three devices feature highly biocompatible polymers.
EntreMed, Inc. (NASDAQ: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of a variety of cancers, announced today the commencement of a multi-center Phase 2 study entitled "Phase II Study of Oral ENMD-2076 Administered to Patients with Ovarian Clear Cell Carcinomas."
The study is led by principal investigator Amit M. Oza, MD at Princess Margaret Cancer Centre in Toronto, Canada with participation of up to seven additional cancer centers in Canada and the United States. More information about the clinical trial can be found at www.clinicaltrials.gov.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal rare diseases, announced that the Company will host an Analyst and Investor Day on Thursday, November 7, 2013 from 2:00pm to 5:00pm in New York City.
Burcon NutraScience Corporation (TSX:BU) (Nasdaq:BUR), a leader in functional, renewable plant proteins, will hold a conference call on Wednesday, November 13, 2013 at 5:00 p.m. Eastern time to discuss its results for its fiscal second quarter ended September 30, 2013.
Gentium S.p.A. (Nasdaq:GENT) today reported financial results for the nine-month period and quarter ended September 30, 2013.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of tools to advance life science research and regenerative medicine, today reported unaudited financial results for the three and nine months ended September 30, 2013.
Innovus Pharmaceuticals, Inc., (OTCBB:INNV) today announced that Dr. Bassam Damaj, Ph.D., President and Chief Executive Officer of the Company, will present at the BIO-Europe 2013 conference to be held in Vienna, Austria on November 4-6, 2013.
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, announced today that it has appointed M&K CPAs as the Company's new independent registered public accounting firm and has thereby dismissed PS Stephenson & Co, P.C. from that role.
Medical Action Industries Inc., (Nasdaq:MDCI), a leading supplier of medical and surgical disposable products, today reported financial results for the second quarter ended September 30, 2013, including net sales of $108.3 million and gross profit of $18.6 million or 17.2% of net sales.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today that the Company and its subsidiary, Progenitor Cell Therapy ("PCT"), will present at multiple upcoming conferences in November.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for the quarter and nine months ended September 30, 2013.
Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today announced that it will host a webcast and conference call to discuss the Company's financial results for the quarter ended September 30, 2013 and to provide a general business overview on Tuesday, November 5, 2013 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced that Adi Frish, RedHill's Senior VP Business Development and Licensing, will present an overview of the Company at the 19th Annual Bio-Europe International Partnering Conference, on Tuesday, November 5, 2013, at 8:45 a.m. CET at the Messe Wien Exhibition and Congress Center in Vienna, Austria.
Reliv International, Inc. (Nasdaq:RELV), a maker of nutritional supplements that promote optimal health, today reported its financial results for the third quarter of 2013.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, will announce its third quarter 2013 financial results and give an operational update in a press release to be issued before the market opens on Thursday, November 7, 2013.
Tauriga Sciences Inc. (OTCQB:TAUG), a diversified company focused on generating profitable revenues through license agreements and the development of a proprietary technology platform in the nanorobotics space, has today announced the appointment of Jason C. Heikenfeld Ph.D ("Dr. Heikenfeld") as the third member of company's scientific advisory board.
Vical Incorporated (Nasdaq:VICL) today reported financial results for the three months and nine months ended September 30, 2013. Revenues were $1.5 million for the third quarter of 2013, compared with $2.2 million for the third quarter of 2012, reflecting ongoing reimbursements from Astellas Pharma Inc. for expenses related to the development of ASP0113 (TransVax™), Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients.
VIVUS, Inc. (Nasdaq:VVUS) announced today that a newly-published study demonstrated Qsymia® (phentermine and topiramate extended-release) capsules CIV produced significantly greater weight loss, and at lower doses, compared to phentermine or topiramate administered as monotherapies in obese adults.