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U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial In Trauma Patients Remains On FDA Hold
Biopure Corporation (Nasdaq: BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure"s oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission, including the most recent, was placed on clinical hold.
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UNICEF: J8 Meets G8
Fourteen young people from countries attending the G8 called on their respective leaders to get tough with countries who don"t meet climate change targets and teachers whose standards slip.
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Nation's First Children's Hospital-Based Safety Store Focuses On Child Injury Prevention
The Riley Safety Store at Riley Hospital for Children, the first of its kind in the nation, serves as a model for children"s hospitals across the nation. Recently expanded, the Riley Safety Store provides space to showcase safety products for children and families, as well as offer different "zones" that simulate home settings and provide families with the opportunity to practice installation and use of child safety products prior to purchase.
Mental Health

A New Take On Growth Factor Signaling In Tamoxifen Resistance

Differences in growth factor (GF) signaling may cause the poor prognosis in some breast cancer cases. A new study, published in the open access journal BMC Medical Genomics, suggests that some estrogen receptor-positive breast cancers respond poorly to tamoxifen because of increased GF signaling. Sherene Loi, from the Peter MacCallum Cancer Centre, Melbourne, worked with a team of Australian and Belgian researchers to investigate the differences between those estrogen receptor positive (ER+) cancers that respond well to tamoxifen (luminal-A) and those that do not (luminal-B). She said, "This is the first study specifically investigating the biology of the luminal-B, ER+ breast cancer subtype. We propose that activation of GF signaling contributes to this highly proliferative, relatively tamoxifen-insensitive, phenotype and that this exists independently of HER2 overexpression. Targeting this pathway and its upstream mediators could prove to be a useful therapeutic strategy". The researchers used a new computational method of analysis of gene expression data called gene set enrichment analysis (GSEA) to determine that there is increased growth factor activation from the gene expression profiles of nearly 100 luminal-B breast cancers samples. They then validated this finding by showing that treatment with the growth factor heregulin, which induced growth factor signaling an in-vitro model, could overcome tamoxifen-induced cell cycle arrest. This research represents a departure from the informative, but sometimes not terribly useful, process of identifying genes associated with given conditions. Dr Loi said, "Although gene expression data has demonstrated its ability to identify subsets of disease and predict outcomes or drug responses, identifying new therapeutic approaches based on whole genome microarray profiling has, to date, been a significant challenge. By using GSEA, we"ve been able to use gene expression data to identify that activation of GF signaling pathways as a possible therapeutic target for further exploration in the clinical setting for these particular breast cancer patients". Notes: 1. Gene expression profiling identifies activated growth factor signaling in poor prognosis (Luminal-B) estrogen receptor positive breast cancer Sherene Loi, Christos Sotiriou, Benjamin Haibe-Kains, Francoise Lallemand, Nelly M Conus, Martine J Piccart, Terence P Speed and Grant A McArthur BMC Medical Genomics (in press) Article. All articles are available free of charge, according to BioMed Central"s open access policy. Graeme Baldwin BioMed Central


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