Phase I/II Investigator-Sponsored Trial in Liver Cancer

[Guest guest]

Phase I/II Investigator-Sponsored Trial in Liver Cancer

Peregrine Announces Initiation of Phase I/II Investigator-Sponsored Trial in Liver Cancer

Investigators Evaluating Novel Monoclonal Antibody Bavituximab in Combination With Sorafenib "Our research has demonstrated that sorafenib increases the exposure of the highly immunosuppressive molecule phosphatidylserine (PS) on tumor vasculature, providing more of a specific target for bavituximab," said Adam C. Yopp, M.D., lead investigator of this trial and assistant professor of surgery at the University of Texas Southwestern Medical Center. "We are eager to determine if combining the growth-blocking mechanisms of sorafenib with the vascular-targeting and immune-reactivation mechanisms of bavituximab offers additive anti-tumor effects for patients with HCC." Currently, Peregrine's bavituximab is being evaluated in combination with chemotherapy in multiple Phase II trials in non-small cell lung cancer and advanced breast cancer, as well as a Phase Ib trial for hepatitis C virus (HCV) and HIV coinfection. Continue Reading........

By WapnerInfectious CuriosityThe course of virologist Charlie Rices career changed with one phone call in 1989. Then at Washington University in St. Louis, Rice was the country & apos;s leading yellow fever expert. The voice on the other end of the line belonged to Feinstone, an FDA scientist asking about a vaccine for the disease that had just won agency approval. Yellow fever virus is a flavivirus. Feinstone wanted to know if Rice could help develop a vaccine to

protect against another flavivirus: hepatitis C. “I can get interested in pretty much anything, I guess,†says Rice.Today, more than 20 years after Rice took that call, hepatitis C virus (HCV) infects about 170 million people worldwide, but those statistics may soon take a downward turn. Two protease inhibitors that recently completed late-stage clinical trials—telaprevir and boceprevir—are curing significant numbers of patients who may otherwise have suffered a lifetime of liver problems. Published studies reported profound responses to treatment with either of these drugs when used in combination with pegylated interferon (PegIFN) and ribavirin—the current standard, but often ineffective, therapy (J.G. McHutchison et al., NEJM, 360:1827-38, 2009 and P.Y. Kwo et al., Lancet, 376:705-16, 2010).Continue reading............ Hepatitis C GI-5005 Vaccine Elicits Immune Response in Some PatientsIn the proof-of-concept trial, 133 patients infected with hepatitis C virus (HCV) genotype 1 were randomized to either triple therapy comprising the experimental GI-5005 vaccine, which is designed to elicit a T-cell response specific to HCV, along with pegylated interferon alfa-2b plus ribavirin (P/R), or the standard P/R therapy alone.Sticking Fast To Foil Hepatitis CBiochemistry: Aiming beyond the

active site of a virus's key protease yields selective blockersCarmen DrahlBy targeting a noncatalytic cysteine, researchers have designed selective irreversible blockers of a protease enzyme essential for hepatitis C virus replication (Nat. Chem. Biol., DOI: 10.1038/nchembio.492).The work is the first demonstration that steering clear of the active site is a viable design strategy for drugs that react to form a covalent bond to proteases, a broad class of proteins that includes many drug targets. This strategy has already proven useful for blocking other proteins such as kinases.Continue reading...........Hepatitis

fears for hundreds of Scots after Spanish outbreak Holehouse1 Dec 2010Hundreds of dialysis patients in Scotland are being called in for screening amid fears they could have contracted the hepatitus C virus from two ish holidaymakers who became infected while undergoing treatment at a clinic in Spain.The male ish victims, one from the NHS Greater Glasgow and Clyde board area and one from the NHS Forth Valley board area, are understood to have received dialysis in September at the Centro Hemodiálisis Nefdial on Majorca.They returned to Britain unknowingly carrying the blood-borne disease – which can cause liver failure – and continued their treatment in Scotland.Health experts say they could have passed it to other dialysis patients in ish hospitals. Health Protection Scotland said the threat was “extremely low†because of the robust infection control measures in place in

Scotland.However, 245 people who may have been treated in the same units as the two people in Scotland are being offered extra screening for hepatitis C.Continue Reading........Pharmasset Initiates Dosing In A Combination Study Of PSI-7977 And PSI-938 For Chronic Hepatitis C01 December 2010Pharmasset, Inc. (Nasdaq: VRUS) announced that dosing has begun in Part 2 of a Phase 1 study. This is the first clinical study combining a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for HCV, and is...[read article]Ikaria® Begins Enrollment Of Pivotal Trial For LUCASSIN®01 December 2010Ikaria, Inc. announced that it has enrolled the first patients in its pivotal Phase III trial for LUCASSIN® (terlipressin). The multi-center, randomized, placebo-controlled, double-blind trial is known as the REVERSE Trial...[read article]Scoring System Is 93% Accurate For Diagnosing 's Disease In Pediatric Patients01 December 2010An Italian research team confirmed that the scoring system for 's disease (WD) provides good diagnostic accuracy with 93% positive and 92% negative predictive values, respectively in children with mild liver

disease...[read article]Merck's Frazier Stresses Science, Innovation For FutureBy GrytaPublished December 01, 2010Dow NewswiresOn Wednesday, Frazier highlighted anti-clotting drug vorapaxar that will have late-stage data in mid-2011 and "could have a significant impact on cardiovascular health.""We believe this could be a very important contributor," he said.He also talked about hepatitis C drug boceprevir, which has shown success in late-stage trials and may hit the market next year, as being an important new product. He noted that 170

million people world-wide have the liver disease and current treatments are toxic and less effective than boceprevir.But in order to get new products to the market, Merck will have to work with the Food and Drug Administration.Frazier praised the agency, noting that it needs more resources in the form of staffing and funding, but he also hinted that the drug review process is becoming a bit too cautious.Continue reading................Ex-model loses Hep C payout action(UKPA) – 5 hours agoA former model who was infected with hepatitis C after being given a blood transfusion more than 20 years ago has lost her High Court bid to challenge

the legality of a Government compensation scheme.A QC for Sharon said at a recent hearing in London that it appeared the Department of Health was "looking for ways of not making payments" to a whole category of people accidentally given contaminated blood in the mid-1980s during "the worst treatment disaster in the history of the NHS".Continue reading...........Researchers Report Surprising AIDS-Treatment Benefits, Prevention Strategy in Epidemic Regions of AfricaTwo teams of researchers at UC San Diego and other U.S. and African universities and the World Bank have

documented significant spillover benefits of a drug therapy to combat AIDS symptoms and a novel prevention strategy that focuses on girls in Sub-Saharan Africa, an area with two-thirds of the world’s HIV infections.In Case You Missed ItHCV Advocate Newsletter, December 2010 Messages From Joe:Walkin To Boston from Santa Cruz,Ca. Hepatitis C Awareness/Nov 30th UpdateVertex Completes FDA Submission of Telaprevir New Drug ApplicationInterim Results

Show TMC435 Works Well in Treatment-experienced Hepatitis C PatientsLiver Cancer: Video Understanding SIR-Spheres microspheres - Whats Being Discussed ?Pharmasset Initiates Dosing in a Combination Study of PSI-7977 and PSI-938 for Chronic Hepatitis CTop News HeadlinesAnti-Microbials Are a Common Cause of Drug-Induced Liver Injury and Failure, Study SuggestsScienceDaily (Nov. 30, 2010) —New research shows that anti-microbial medications are a common cause of drug-induced liver injury (DILI) leading to acute liver failure (ALF), with

women and minorities disproportionately affected. While ALF evolves slowly, once it does occur a spontaneous recovery is unlikely; however liver transplantation offers an excellent survival rate. Full findings of this ten-year prospective study are published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.Health Forum Sees Sacrifices for Doctors, Insurers - December 01, 2010(The New York Times News Service) -- Health care costs can't continue to rise rapidly without crippling the state's economy and public services. But efforts to rein them in will require new team-based health care payment and delivery approaches, which would demand sacrifices from hospitals, doctors, and insurers.Foods May Help Ward Off Cold, Flu - December 01, 2010(The Atlanta Journal-Constitution) -- The holiday season is upon us, and along with the festive lights and music, we often encounter the not-so-welcome sounds of coughing and sneezing.Calcium, Vitamin D Changes Suggested - November 30, 2010(The New York Times News Service) -- A long-awaited report from a panel of independent scientists recommends tripling the amount of vitamin D most Americans should take and small increases in calcium levels for children to build and maintain strong bones, but some specialists warned that the recommendations were flawed.Public Release: 1-Dec-2010Journal of VirologyBUSM researchers show an oncolytic virus switches off cancer cell surival signalResearchers from Boston University School of Medicine have identified a mechanism by which specific viruses acting as oncolytic agents can enter and kill cancer cells. This finding, which is currently featured in an online edition of the Journal of Virology, could help lead to the development of more targeted treatments against many types of cancer. National Institutes of HealthBeyond Stem Cells: Scientists Transform Skin Cells to Nerve, Heart, Blood Cells - November 30, 2010NEW YORK, N.Y. (Canadian Press) -- Suppose you could repair tissue damaged by a heart attack

by magically turning other cells into heart muscle, so the organ could pump effectively again.Public Release: 1-Dec-2010 American Journal of Human GeneticsResearchers identify gene tied to extremely rare disorder that causes inflammation and loss of fatUT Southwestern Medical Center researchers have identified a gene responsible for a rare disease that results in severe joint stiffness, muscle loss, anemia and panniculitis-induced lipodystrophy, or JMP syndrome. National Institutes of HealthPublic Release: 1-Dec-2010 Physics WorldPhysicists use graphene

to decode DNAGenome sequencing will have a profound effect on our understanding of genetic biology and could usher in a day when doctor and patient are able to review individual genome sequences to fully personalize medical treatment.Vaccination Nation: One And DoneBETHESDA, MD (Ivanhoe Newswire) -- This is something no one wants to hear. This month kicks off flu season! Sadly, you’re most at risk for the flu between the months of November and March.Full News Report »

http://Hepatitis Cnewdrugs.blogspot.com/2010/12/dec-1st-hepatitis-c-news-phase-iii.html