Hepatitis C study: Drug fails

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  • Wednesday, December 15, 2010
  • Posted by New HCV Drugs
  • File Under


Good evening folks,
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The big story this evening is the drug SCV-07 which has failed to meet its goal midstage in the companies phase 2 clinical trial :
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By The Associated Press
SciClone Pharmaceuticals Inc. said Wednesday that its drug candidate SCV-07 failed to meet its key goal of treating Hepatitis C in a midstage study, prompting a cancellation of the program.
The company said the study was aimed at providing an estimate of whether SCV-07 could be a potential treatment for Hepatitis C, which is a viral condition that damages the liver."Although the data showed an interesting biological signal, due to the rapidly changing landscape of effective treatments which increase the complexity and risks of developing drugs in chronic Hepatitis C, we have decided not to continue development in this indication," said President and CEO Friedhelm Blobel, in a statement.
In March, the drug candidate failed in a midstage study on oral mucositis, which is an inflammation of the digestive tract. It is a common side effect of patients undergoing chemotherapy for head and neck cancer.
The company plans to start another midstage study in 2011 aimed at oral mucositis involving higher doses of the drug candidate.Shares of SciClone fell 79 cents, or 19.8 percent, to $3.20 in afterhours trading, after falling 9 cents to close at $3.99 during the regular trading session. The stock has traded between $2.08 and $4.50 over the last 52 weeks.Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
Read More SciClone Announces Topline Results From Phase 2b Clinical Trial of SCV-07 for Treatment of Chronic Hepatitis C
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GEORGINA O'HALLORAN
THE QUALITY of donor livers has deteriorated in recent years, an inquest into the death of a 29-year-old man following a liver transplant has been told.Michael Burke of Oak Park, Tralee, Co Kerry, had a “super-urgent” liver transplant at St Vincent’s University Hospital, Dublin, on January 2nd, 2010, in a “heroic effort” to save the life of the father of three.
The transplanted liver failed to function properly after the procedure and Mr Burke developed multi-organ failure and died at the hospital on February 6th, 2010.
Dublin City Coroner’s Court heard the liver Mr Burke received, from the UK, was “suboptimal” and enlarged with some fat.
One of the problems with fatty livers is that they do not work as well, the inquest heard. This was the only available liver which matched Mr Burke’s blood group – and so had to be accepted.
When an individual is on the super-urgent list, doctors must accept the first available liver which matches the blood group
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Today medscape added a new " What Do You Think Mr. Doctor So and So" article. I really enjoy reading these little scenarios even when I can't offer any validity for doing so. Still, its often a good read and even a bit of winter entertainment:
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A patient who had jaundice many years previously now shows hepatitis B core antibody. What does this mean?
Medscape Gastroenterology, December 2010


In case you missed Pharmassets press release yesterday on PSI-7977 here it is with a few other updates from Medical News Today:
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Pharmasset Initiates Exploratory Interferon Sparing Clinical Trial Of PSI-7977 For Chronic Hepatitis C

15 December 2010

Pharmasset, Inc. (Nasdaq: VRUS) announced that dosing has begun in an exploratory study of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV)...

Y-90 Radioembolization Offers Promise For Late-Stage Liver Cancer

15 December 2010

The latest weapon against inoperable liver cancer is so tiny that it takes millions of them per treatment, but according to interventional radiologists at the Indiana University School of Medicine, those microscopic spheres..


EHSI: Celulas Genetica To Patent Breakthrough Stem Cell Treatment

14 December 2010

Emerging Healthcare Solutions, Inc. (PinkSheets:EHSI) announced that its newly acquired biotechnology division Celulas Genetica will submit an international patent application for the Rutherford Procedure, a revolutionary.

Over at NAM Aidsmap according to the European recommendations good response rates to therapy is seen in patients who start treatment within the first year of contracting the virus.

European recommendations issued on acute hepatitis C infection in patients with HIV
European investigators and activists have developed recommendations for the management of acute hepatitis C infection in patients with HIV.
Published in the online edition of AIDS, they cover the diagnosis, epidemiology, natural history and treatment of the infection.
It is estimated that approximately a third of HIV-positive patients in Europe are co-infected with hepatitis C. The epidemic of sexually transmitted hepatitis C among HIV-positive gay men has lead to a renewed focus on the infection. Therefore in May 2010 doctors, researchers and activists from a number of European-wide bodies met in Paris to develop consensus guidelines about the management of acute hepatitis C infection

From Natap :

AASLD: A Phase IIa Study of IDX184 in Combination with Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Treatment-Naïve Genotype 1 HCV-Infected Subjects -
(12/13/10)


AASLD: Phase I Study in Healthy Volunteers and Patients with IDX375, a Novel Non-Nucleoside HCV Polymerase Inhibitor -
(12/13/10)


AASLD: Antiviral Activity, Safety and Pharmacokinetics of IDX320, a Novel Macrocyclic HCV Protease Inhibitor, in a 3-Day Proof-of-Concept Study in Patients with Chronic Hepatitis C - (12/13/10)


AASLD: Steatosis, Obesity, Peg-IFN Dose Reduction & Menopause are Associated with Relapse in Chronic Hepatitis C Patients Treated with Pegylated Interferon Plus Ribavirin -
(12/13/10)


AASLD: IL-28B Genotype is a Major Determinant of the Induction of a Virological Response by
High-Dose Peginterferon and Ribavirin in Null-responders to SOC Therapy: Pegasys double-dose significantly increased early virologic response -
(12/13/10)

From Hepatitis C New Drug Research and Liver Health:
Hey, I have a question about this IL28B gene and hepatitis c treatment.....


Online at CNN there is an inspiring story about Dr. Doug Lefton of Fairlawn, Ohio who found a way to help patients afford the blood tests they so badly need.
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Day after demoralizing day, Dr. Doug Lefton watched uninsured patients leave his office needing laboratory tests but unlikely to have them done because of the cost. "It's a little heartbreaking when you have someone in your office and they need a blood test and they won't do it because they can't afford it," Lefton, 56, said. So the Fairlawn, Ohio, family physician decided to do something about it. Working with other doctors and an online marketer, Lefton devised a way to slash the cost of lab tests not only for his patients but for almost anyone, anywhere.


Additional Medical News
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Nature
More than 2,000 genetic regions involved in early human development have been identified by researchers at the Stanford University School of Medicine. The regions, called enhancers, are responsible for triggering the expression of distant genes when embryonic stem cells begin to divide to form the many tissues of a growing embryo.
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Shorter Time to Call Brain Death Eases Transplant Picture

1 hour ago
A single examination to determine brain death -- rather than the two time-separated ones that have been recommended -- should be sufficient before the process of organ donation is begun, researchers urged.

Human Interest Story

NPR's Fresh Air audio; brings to us this interview of a physician who was diagnosed with the very disease she treats, breast cancer. Marisa Weiss, MD, is an oncologist which founded breastcancer.org and has treated patients with breast cancer for twenty years. This is more then worth your time folks.

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