Roche suspends phase II trial of its anemia drug

Swiss drug maker Roche Holdings AG announced Monday it is temporarily suspending recruitment into its phase II testing of the drug Cera, a treatment for anemic patients with advanced non-small cell lung cancer receiving chemotherapy.
Posted : Tue, 27 Feb 2007 08:20:01 GMT
By : Helen Steele
Category : Health
News Alerts by Email ( click here )
Health News | Home
ZURICH: Swiss drug maker Roche Holdings AG announced Monday it is temporarily suspending recruitment into its phase II testing of the drug Cera, a treatment for anemic patients with advanced non-small cell lung cancer receiving chemotherapy.

The company said it is calling off the studies became of an imbalance in the number deaths in the study and on the recommendation of an independent Drug Safety Monitoring Board involved in the study. Treatment of already enrolled patients with the drug will, however, continue.

The phase II study was to assess the optimal starting dose of the drug in patients with the disease.

Investigators had reported all deaths to be unrelated to the study drugs. Roche said the numerical imbalance has been noticed in the number of deaths across the four arms of the study -- three arms with Cera and one with another drug darbepoetin alfa -- and it believed this could be in part by deaths reported to be due to the progression of the underlying cancer (stage IIIb and IV of non-small cell lung cancer).

The company has not noticed any such imbalance in previously completed studies using Cera in cancer patients receiving chemotherapy. In an ongoing study in Japan, there have been no reported deaths during the clinical trial period.

Cera forms part of a class of drugs that contain a natural protein, erythropoietin (EPO), which counters anemia by boosting the body's production of red blood cells.

Drug company Amgen had reported higher death risk among patients taking its drug Aranesp, which also contains EPO. Its another drug, Epogen, and Johnson & Johnson's drugs Procrit and Eprex also belong to this class.

There are 153 patients who are participating in the study. Roche said safety data from the patients continuing in the study will be closely monitored in association with the Drug Safety Monitoring Board. It is also investigating the potential causes for the imbalance.

Roche's Cera product has a brand name, Mircera. The company did not say how many deaths have taken place in the four arms of the trial.

Meanwhile, the company said its another drug, Avastin, has been recommended for use in Japan in patients with advanced or recurrent colorectal cancer. A formal approval should be coming by mid-year, the company said. The drug is expected to have potential sale of $8 billion a year. It works by stopping blood supply to tumors. It has already secured approval for the drug in the U.S. and Europe for treatment of colorectal cancer and non-small cell lung cancer.

Copyright, respective author or news agency

Share/Save/Bookmark

Article : Roche suspends phase II trial of its anemia drug
Print this article
Email this article

Stay Updated
News gadget on your Google homepage
Subscribe to a news feed in Google Reader


Related News

US House passes major health reform - Summary
Washington - The US House of Representatives passed a landmark health reform bill aimed at cutting costs and extending coverage to Americans who lack insurance. The House vote late Saturday marked the biggest victory yet for President Barack Obama's ...

House passes major health reform - Update
Washington - The US House of Representatives late Saturday passed a landmark health reform bill aimed at cutting costs and extending coverage to Americans who lack insurance. The House vote marked the biggest victory yet for President Barack Obama's ...

Bulgaria closes schools to curb flu outbreak
Sofia - Bulgarian health authorities said Friday that they ordered schools to remain closed Monday in order to try to curb the spread of swine flu. As the number of the infected continued to rise quickly, the government also said hospitals were to de...

Drug tested only on mice saves Australian baby
Sydney - An Australian doctor who used a German experimental drug that had been tested only on mice to save a baby's life left Friday to brief US and European medical authorities about the amazing success. In a race against time, doctors at the Monas...

US health reform wins major endorsements from doctors, seniors
Washington - President Barack Obama's hopes of overhauling the US health care system were given a major boost Thursday as two advocacy groups representing doctors and seniors backed the reforms. The American Medical Association (AMA) and AARP both is...

Charity warns West may be backtracking on AIDS treatment - Summary
Johannesburg - A leading international medical charity on Thursday warned that Western governments were showing signs of backtracking on their commitment to increase access to life-saving treatment for AIDS patients. Dr Tido von Schoen-Angerer, a dir...

Death toll still rising in Ukraine's flu outbreak
Kiev - The death toll in Ukraine's flu outbreak continued to rise on Thursday. A total of 95 persons have died from flu-related symptoms since the disease struck Ukraine's western provinces late last month, said Zinovy Mytnik, vice health minister, i...

Have your Say
Name
Email
Subject
Your Comment

Enter Verification code
 
  

 

 

More Health News click here
Follow The Earth Times
Subscribe to RSS Follow Earth Times on TwitterNews by email
Share/Save/Bookmark

 
 



 
Subscribe to free Earthtimes
News Alerts by Email Click here
For RSS Feeds Click here
or Create your own RSS

Add to Google Toolbar
Breaking News
Press Releases

 
 
Roche Holdings AG


The Earth Times
News Category

© 2009 www.earthtimes.org, The Earth Times, All Rights Reserved | Privacy Policy
Earth Times accept no responsibility or liability either directly or indirectly for views or opinions expressed in articles or comments.