The Registry should provide robust real-world evidence to characterize the effectiveness, safety and clinical impact of SIR-Spheres® Y-90 resin microspheres, Sirtex's targeted radiation therapy. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. The company now has no major capital expenditure requirements, so almost all of profits convert quickly into cash. The registry should provide robust real-world evidence to characterize the effectiveness, safety, and clinical impact of SIR-Spheres Y-90 resin microspheres, Sirtex's targeted radiation therapy. Support and assist, where appropriate, third-party business partners engaged in clinical trial or other programs. Sirtex is a global healthcare business with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. A new analysis of the MORE data on 606 mCRC patients treated with SIR-Spheres Y-90 resin microspheres at 11 U.S. medical centres, published late last year in the journal Clinical Colorectal Cancer, confirms that patient age is not a barrier to appropriate treatment with SIR-Spheres® Y-90 resin microspheres, Sirtex reported today. . The following toxicity events were observed during the randomized clinical trial with 34 patients on Sirtex Medical (ASX:SRX) shares are down slightly today after its radioactive microspheres failed to meet the primary endpoint in a liver cancer trial.. Patients will take regorafenib 160 mg orally once daily on Days 1-21 of each 28-day treatment cycle. • as the senior in the team to provide guidance, mentoring & training to the CRAs team & to perform onsite co-visits/quality visits. Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and…See this and similar jobs on LinkedIn. Sirtex Medical Limited announced this morning it had completed patient enrolment for a randomised, controlled clinical study directly comparing the company's SIR-Spheres against the existing . Under his leadership, the Sirtex team will continue to support and promote the company's products to further advance the field of oncology treatment and deliver the highest level of patient care and provider focus. About Sirtex. The trial patient population is reflective of real-life settings, also increasing clinical applicability. These papers have been from a variety of clinical trial and experiential settings and are presented Clinical Trial Assistant jobs 9,468 open jobs Regulatory . Clinical Trials Regulation . Have a clear understanding of health/product reimbursement related to Sirtex. Sirtex Medical completes enrollment of landmark U.S. RESiN registry. Sirtex has faced a barrage of obstacles this year, including a number of clinical trials that failed to meet primary endpoints. Industry veteran to lead Medical and Clinical Affairs to advance clinical trials and accelerate further development of cancer therapiesWOBURN, Mas. … Although the scientific sessions at the 2017 American Society of Clinical Oncology annual meeting were dominated by basic research and drug trials, the meeting also featured many presentations on novel drug-delivery, radiation, and diagnostics technology. March 22, 2021. Dr. The company's SIR-Spheres Y-90 resin microspheres did not improve survival in patients with advanced hepatocellular carcinoma compared to a group treated with the current standard of care, sorafenib. Treatment with regorafenib will be re-started 2-4 weeks after SIR-Spheres administration. Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres ® Y-90 resin microspheres. Sirtex - Clinicians Clinicians Management of liver tumors from metastatic colorectal cancer (mCRC) presents a complex challenge to oncologists and multidisciplinary treatment teams. SIR-Spheres are resin-made microspheres used for SIRT. If you want to be part of a highly motivated and qualified team, and to make a substantial improvement to the quality of people's lives, a fantastic opportunity currently exists for a Clinical Trials Assistant. More than 100,000 doses have been supplied to treat patients with liver . . SINGAPORE, May 18, 2017 /CNW/ - The SIRveNIB abstract published on-line in the Journal of Clinical Oncology states that treatment of locally advanced Hepatocellular Carcinoma (HCC) with a single treatment of SIR-Spheres® Y-90 resin microspheres results in Overall Survival not significantly different from twice-daily oral sorafenib, but with significantly better tumour response and . Some of the days required the hard copy file system to be constructed before files were put away. He will develop the strategic vision for Sirtex's clinical trial portfolio, including registration and post-registration trials. Understanding of the reimbursement and funding structure and process for medical devices/pharmaceuticals in France. This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. Steve Chartier, RAC Vice President of Clinical Affairs at Sirtex Medical Limited Greater Boston 500+ connections Sirtex supports healthcare professional education events, accredited programs including live presentations, symposia, regional/local . More than 100,000 doses have been supplied to treat patients with liver . Clinical trials have shown SIRT increases the time-to-disease progression and overall survival without adversely affecting the patient's quality of life.3 In clinical studies, SIR-Spheres microspheres have been combined with modern chemotherapy or administered as a monotherapy during a chemotherapy holiday and have been proven to: 4, 5-11 The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC), National Cancer Centre Singapore, Singapore Clinical Research Institute (SCRI) and Sirtex Medical Limited announced that the AHCC protocol 06 SIRveNIB randomised controlled study of SIR-Spheres Y-90 resin microspheres versus sorafenib in the treatment of unresectable primary liver . Sirtex's current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres ® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver . Under his leadership, the Sirtex team will continue to support and. Sirtex (Australia) Dong-A-ST Co., Ltd. (South Korean) Sanaria, Inc. (USA) Sirtex Medical US Holdings, Inc., a manufacturer of targeted liver cancer therapies, reports that enrollment in the U.S. RESiN Registry has reached a milestone of 1,650 patients and 12.8 months of follow-up, allowing for a satisfactory number of patients enrolled for meaningful data analysis. Median PFS and hPFS are static, one-time values at the 50% percentile; the HR improvements with TARE of 0.69 and 0.59 reflect the clinical benefit along the entire continuum of the KM curve, translating into a 31% and 41% risk reduction of . Clinical Trials Registry. Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and Singapore, working to improve outcomes in people with cancer. More than 100,000 doses have been supplied to treat patients . This therapeutic modality requires the combined efforts of multiple medical disciplines to ensure the safe delivery of yttrium-90 (90 Y)-labeled microspheres.The development of this therapy followed decades of clinical research involving tumor vascularity and . Sirtex Supports the First Pilot Study Evaluating SIR-Spheres® Microspheres in Combination with Bevacizumab and Chemotherapy as a First Line Treatment for Metastatic Colorectal Cancer Prospective Multi-Center Trial to evaluate safety and tolerability of combination therapies in patients with advanced liver disease LAKE FOREST, IL (February 9, 2007) Sirtex, a leading developer of targeted and . Sirtex Announces Clinical Trial Evaluating the Use of SIR-Spheres® Microspheres with Xeloda® for Metastatic Liver Cancer Combination Therapy Trial Signals New Trend in Microspheres Treatment PHILADELPHIA, Pa. (May 8, 2006)  Sirtex, a leading developer of targeted and innovative cancer therapies, announces the launch of a clinical trial . Sirtex is a global healthcare business company with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Senior Clinical Research Associate. We include a brief summary of clinical trials regulatory elements in the drug development process. Have a clear understanding of health/product reimbursement related to Sirtex. NASIR-HCC, a multicenter phase 2 single arm clinical trial, evaluated the safety, tolerability, and preliminary antitumoral efficacy of selective internal radiation therapy (SIRT) using Sirtex's lead product SIR-Spheres® Y-90 resin microspheres, followed by Nivolumab, a targeted anti PD-1 cancer therapy manufactured by Bristol Myers Squibb . LAVA clinical trial underway for potential first FDA-approved liquid embolic system for a peripheral vascular indication. The new chief appears to be shaping Sirtex into a more digestible meal. Understanding of the reimbursement and funding structure and process for medical devices/pharmaceuticals in Germany. Durham, NC, November, 29, 2021 - Cardiovascular Safety Research Consortium (CSRC) will convene a broad group of stakeholders including U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) representatives, clinicians, and industry representatives, to examine the issue of cardiovascular safety in oncology clinical . Conclusions: In the advanced-stage hepatocellular carcinoma population, two large randomised trials have shown that SIR-Spheres have similar clinical effectiveness to sorafenib. A systematic review was conducted using the databases MEDLINE, Embase, and Cochrane Trials Register to identify all relevant studies. Sirtex Medical US Holdings, Inc. ("Sirtex"), a leading manufacturer of targeted cancer therapies, announced an advancement in its strategic collaboration with OncoSec Medical, Inc. (NASDAQ: ONCS . SIR-Spheres is a . Here is a list of some recent trials that launched within the cancer space in April. Here are some of the highlights of this year's meeting, which was held in Chicago June 2-6. Adverse Effects of the Device on Health . Support and assist, where appropriate, third party business partners engaged in clinical trial or other programs. He will develop the strategic vision for Sirtex's clinical trial portfolio, including registration and post-registration trials. He will develop the strategic vision for Sirtex's clinical trial portfolio, including registration and postregistration trials. The clinical trial is a single arm trial and patients will be recruited in the near future. Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, announced full FDA approval of the DOORwaY 90 Study, a trial evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres ® Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma (HCC). SIR-Spheres® has not been withdrawn from marketing for any reason relating to the safety or effectiveness of the device. None of the selective internal radiation therapies was cost-effective, being more costly and less effective than lenvatinib, both at list price and with Patient Access . Patients and Methods Chemotherapy-naïve patients with . Between the research cuts, clinical trial wind-up, and staff reduction, Sirtex's high-spending days are over. From this site, you will be able to submit, track, update, and manage requests for educational grants, charitable donations, and research grants. 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