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Scientists are anticipating a breakthrough in the treatment of patients with a chronic inflammatory disease ahead of a final phase III trial of the drug belimumab.
BLISS-76 is the second of two pivotal phase III randomised clinical trials of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus (lupus).
The drug is being developed by Human Genome Sciences (HGS) and GlaxoSmithKline under a joint development and commercialisation project agreed in August 2006.
“If LymphoStat-B is successful in phase III, we believe that it could represent a breakthrough in the treatment of patients suffering from lupus,” said H Thomas Watkins, president and chief executive of HGS.
“We are on track to have data from our first phase III trial by mid-2009, and data from our second phase III trial by autumn 2009. Assuming positive results, we anticipate a BLA (Biologic Licence Application) filing in the United States in the first half of 2010.”
BLISS-76 began in February last year and has enrolled 826 patients in 19 countries, mainly in North America and Europe. The first phase III trial, BLISS-52, completed the enrolment of 867 patients in Asia, South America and Eastern Europe this April.
Copyright PA Business 2008
“Yes, I do have high hopes. My wife has suffered from SLE since 2000. Although the flares are less common, we are still suffering from side affects from all 7 medications she is currently taking.” – JC, Atlanta, USA