ROADSTER pivotal results (presented by Christopher J. Kwolek, MD) In the recent CREST trial, transfemoral carotid artery stenting (CAS) showed an excess periprocedural stroke rate (4.1%) when compared to carotid endarterectomy (CEA) (2.3%), while CEA was shown to carry risks of surgical complications including cranial nerve injury (CNI) (4.8%). ROADSTER is a prospective, multicenter, investigational device exemption study designed to evaluate the safety and effectiveness of a novel hybrid carotid revascularization procedure using the ENROUTE transcarotid neuroprotection system (NPS) (Silk Road Medical, Inc.). The primary endpoint was a composite of any stroke (S), myocardial infarction (MI), or death (D) through 30 days. Symptomatic and asymptomatic patients who were at high risk for complications from CEA were eligible. Between November 2012 and July 2014, 208 patients (67 lead-in, 141 pivotal) were enrolled at 18 hospitals. FDA-approved carotid stent systems, chosen according to site preference, were delivered through the direct carotid access point under high-rate flow reversal afforded by the ENROUTE NPS. Baseline pivotal population characteristics included 26% symptomatic, 35% female, and 47% age 75 or older; 56% of patients had physiologic risk factors, and 69% had anatomic risks. In the intention to treat (ITT) population, the rates for S/D/MI, S/D, and any stroke were 3.5%, 2.8%, and 1.4%, respectively. In a per protocol (PP) analysis (n = 136), the outcomes were 2.9%, 2.2% and 0.7%, respectively. There were no strokes in patients age 75 or older, nor in symptomatic patients. Transient CNI at 30 days was 0.7% and fully resolved. The upper 95% confidence interval of the hierarchical primary endpoint event rate in ROADSTER (3.5%) was statistically significantly less than the objective performance criterion (11%; P = .0047). Notably, the any stroke rate of 1.4% (0.7%, PP) in a high surgical risk population is the lowest to date for CAS and comparable to the periprocedural standard surgical risk CEA arm of CREST (2.3%). The ENROUTE transcarotid NPS appears to be safe and effective for obtaining direct carotid access and preventing embolic events during CAS.
Read More: http://www.prnewswire.com/news-releases/late-breaking-clinical-trial-results-announced-at-viva-14-281541771.html
Via: PR Newswire
REDWOOD CITY, Calif., Nov. 3, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, has been granted a new patent (U.S. Patent No. 8,858,941) in the United States for OncoMed's anti-DLL4/anti-VEGF bispecific antibody (OMP-305B83) and use of the bispecific antibody in the treatment of cancer. The new patent includes both composition-of-matter and method of treatment claims for the antibody. Related patent applications are pending in the United States, Europe, Japan, China and a number of other countries worldwide.
OncoMed to Present Clinical and Preclinical Data at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Meeting
Phase I Data on Anti-Notch1 Selected for Oral Plenary Presentation
Wright Medical Group Inc. (WMGI:US), a U.S. maker of bone implants, will merge with Tornier NV, creating a new company valued at $3.3 billion in the latest proposed tax inversion since tighter rules were announced last month.
The Lutonix® 035 Drug Coated Balloon is the First and Only FDA-Approved DCB Available in the U.S. for the Treatment of Femoropopliteal Occlusive Disease
Via: Business Wire
MURRAY HILL, N.J.--(BUSINESS WIRE)--C. R. Bard, Inc. (NYSE: BCR) today announced the U.S. Food and Drug Administration (FDA) approval of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm. This approval follows a unanimous favorable recommendation from the FDA’s Circulatory Systems Devices Advisory Panel in June 2014. The Lutonix® 035 DCB—the first and only FDA-approved DCB in the U.S.— is an angioplasty balloon coated with a therapeutic dose of the drug paclitaxel, and also utilizes standard mechanical dilatation of the vessel to restore blood flow for patients with peripheral arterial disease (PAD) in the femoropopliteal arteries.
Via: BMO Capital Markets
OncoMed (OMED) presented updated results from two phase 1b trials of
OncoMed Presents Encouraging Data From Clinical Trials of Tarextumab (Anti-Notch2/3) in Pancreatic Cancer and Small Cell Lung Cancer at the ESMO 2014 Congress
Data Supports Phase 2 ALPINE Study of Tarextumab in Pancreatic Cancer and Phase 2 PINNACLE Trial in Small Cell Lung Cancer
OncoMed's Demcizumab Phase 1b Clinical Trials Show Encouraging Safety and Anti-Tumor Activity at ESMOResults Support Advancing Demcizumab Into Randomized Phase 2 Clinical Trials
MADRID and REDWOOD CITY, Calif, Sept. 28, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented safety and efficacy data from two Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in pancreatic cancer and non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.
REDWOOD CITY, Calif., Aug. 28, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), announced today that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on enrollment in the company's vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials. Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. Enrollment and dosing of new patients is expected to resume within the next few weeks as the study sites' institutional review boards (IRBs) receive and approve the revised trial protocols.
Via: Med City News
About half of all strokes could be caused by a narrowing of the carotid artery – the pipeline that ushers blood flow through the neck and to the brain. The Bay Area’s Silk Road Medical may have found a less-invasive way to increase the blood flow to the brain, using traditional stenting concepts but kicking ‘em up a notch.