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news.Human Genome Science has received a special protocol assessment from the FDA, agreeing to the company's phase III clinical development program for its antibody LymphoStat-B in patients with lupus.
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“We expect to initiate phase III trials of LymphoStat-B before the end of 2006, and we look forward to moving ahead with site activation and patient enrollment,” said Thomas Watkins, president and CEO, Human Genome Sciences.
The phase II results show that LymphoStat-B significantly reduced disease activity in serologically active patients, the population in which the drug will be studied in phase III.
LymphoStat-B was recently designated as a fast track product.
Human Genome Sciences previously disclosed that it has met with the European Agency for the Evaluation of Medicinal Products, and has received agreement on the major components of the phase III clinical development program. Human Genome Sciences designed the program in collaboration with GlaxoSmithKline.
Lupus is a life threatening disease and symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems.