Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

Posts Tagged ‘efficacy’

Augmenix Announces Positive Clinical Trial Results Demonstrating Efficacy of SpaceOAR

Posted by fidest press agency su venerdì, 29 settembre 2017

prostateResearchers have long known that higher radiation doses (dose escalation) are more effective at killing tumors. However, the amount of radiation safely delivered to the prostate is limited by the rectum proximity, and concerns of creating long-term rectal injury and associated side effects. Physicians at the University of Texas Southwestern Medical Center and Memorial Sloan Kettering Cancer Center recently evaluated 44 men receiving SpaceOAR Hydrogel followed by dose-escalated (45 Gray) SBRT. The data show that SpaceOAR Hydrogel significantly reduces rectal injury in men undergoing high-dose SBRT for prostate cancer. Specifically, 13.6 percent of treated men had rectal mucosal injury in the study, all of which were mildly symptomatic and completely healed within six months following treatment. These findings are significant, as prior clinical research found that 90 percent of non-SpaceOAR Hydrogel patients treated with the same SBRT regimen experienced similar radiation-induced mucosal injury due to higher rectal wall radiation doses. None of the patients exhibited signs of biochemical cancer recurrence in the 12-month follow up period.“Hypofractionated approaches are gaining momentum in the treatment of prostate cancer, and in our experience, high-dose regimens have provided exceptionally high rates of biochemical control, but at the cost of an increased risk of rectal complications associated with the rectal wall dose,” said Michael Folkert, MD, radiation oncologist and brachytherapy specialist at University of Texas Southwestern Medical Center in Dallas. “Our new study demonstrates that use of the perirectal hydrogel spacer gets us the ‘room’ we need to safely deliver the most potent therapeutic doses to patients, which may ultimately lead to the optimal cancer control while significantly reducing the risk of treatment related complications.” As the first and only prostate cancer spacing device to receive Food and Drug Administration (FDA) clearance, SpaceOAR Hydrogel is placed between the prostate and rectum, protecting the rectum and surrounding tissue from high-dose radiation exposure. Long-term clinical data has shown that at both three and five years post-radiation therapy (using Intensity Modulated Radiation Therapy), patients treated with SpaceOAR Hydrogel demonstrated significant bowel, urinary and sexual function benefits.1-3
“We are excited by the successful results from this study, as it is the first time we’ve evaluated SpaceOAR Hydrogel in prostate cancer patients treated with high-dose SBRT, and the findings confirm a significant clinical benefit,” said John Pedersen, CEO, Augmenix. “As this robust data indicates – along with the other positive data on our hydrogel spacing technology presented this week at ASTRO – we remain steadfast in our vision to develop disruptive medical technology that improves the lives of patients receiving radiation therapy.”Prior SpaceOAR Hydrogel clinical studies have demonstrated significant reductions in long-term radiation side effects, and improvements in patient quality of life following the delivery of standard prostate radiation doses. This recent study was designed to see if SpaceOAR Hydrogel allows for safe prostate dose escalation, which if proven safe in other studies, has the potential to reduce cancer recurrence rates following prostate radiotherapy.For more information on SpaceOAR Hydrogel, visit http://www.SpaceOAR.com. (photo: prostate)

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Protection against a virus

Posted by fidest press agency su sabato, 6 giugno 2009

The World Health Organization has recommended that rotavirus vaccination be included in all national immunization programmes in order to provide protection against a virus that is responsible for more than 500,000 diarrheal deaths and two million hospitalizations annually among children. More than 85 percent of these deaths occur in developing countries in Africa and Asia. This new policy will help ensure access to rotavirus vaccines in the world’s poorest countries. The new recommendation by the WHO’s Strategic Advisory Group of Experts (SAGE), extends an earlier recommendation made in 2005 on vaccination in the Americas and Europe, where clinical trials had demonstrated safety and efficacy in low and intermediate mortality populations. New data from clinical trials which evaluated vaccine efficacy in countries with high child mortality has led to the recommendation for global use of the vaccine. This is reported in the Weekly Epidemiological  The GAVI Alliance, vaccine manufacturers, and the public health community made an unprecedented commitment to understand how these vaccines would work in developing-world conditions. The clinical trial, funded in part by GAVI and conducted by PATH, WHO, GlaxoSmithKline (GSK), and research institutions in high-mortality, low-socioeconomic settings of South Africa and Malawi, found that the vaccine significantly reduced severe diarrhea episodes due to rotavirus. In 2006, the GAVI Alliance added rotavirus vaccines to its portfolio of vaccines for which it provides financial support to developing countries, underscoring GAVI’s commitment to reduce the traditional 15 to 20 year lag between the introduction of new vaccines in wealthy countries and their availability in the developing world. Today, WHO’s global recommendation paves the way for low-income countries in Africa and Asia to apply to GAVI for introduction of rotavirus vaccines— just three years after new rotavirus vaccines became available in the US, Europe, and Latin America.  Because oral vaccines can have variable efficacy in different populations, it was important to demonstrate vaccine performance in high-mortality settings. The studies in Africa were conducted among populations with high infant and child mortality, poor sanitary conditions, high diarrheal disease mortality and high maternal HIV prevalence.  The clinical trial investigators from Malawi and South Africa will present and publish their data on the GSK RotarixTM vaccine later this summer. Clinical trial sites in Bangladesh and Vietnam—along with sites in Ghana, Mali, and Kenya—evaluated the performance of Merck’s rotavirus vaccine, RotaTeq®, and data are expected in Fall 2009. While efficacy data from Asian countries are forthcoming, SAGE recommended rotavirus vaccines for all populations, including Asia, since available evidence indicates that efficacy data can be extrapolated to populations with similar mortality patterns regardless of geographic location.  WHO, UNICEF, and other GAVI partners are working together in a new accelerated and integrated approach to combat rotavirus diarrhea and pneumonia, the two biggest vaccine-preventable diseases which together account for more than 35 percent of all child deaths each year, the majority of which are in the developing world.

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