LymphoStat-B (belimumab) patients with active lupus(SLE).

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Phase III Trials of LymphoStat-B in Lupus

Pain & Central Nervous System Week - Nov. 24, 2006
 
Human Genome Sciences, Inc., (HGSI) (HGS) announced that it has received a special protocol assessment (SPA) from the U.S. Food & Drug Administration (FDA), agreeing to the company's phase III clinical development program for LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus (SLE).

"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 H. Thomas Watkins, president and CEO, Human Genome Sciences. "We believe that this novel antibody drug will become an important therapeutic option for patients suffering from SLE. For HGS, advancing LymphoStat-B to late-stage clinical study is a critically important step in our evolution into a commercial organization."

The design of the LymphoStat-B phase III development program includes a primary efficacy endpoint that emerged directly from the previously reported results of a phase II clinical trial. The endpoint is a combined patient response rate that includes elements of the SELENA SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. These measures are well-known to clinical investigators with experience in SLE. The phase II results show that LymphoStat-B, as measured by this combined response rate, significantly reduced disease activity in serologically active patients, the population in which the drug will be studied in phase III.

"The positive special protocol assessment received from the FDA leaves no issues outstanding, and provides HGS with confidence that the design of the phase III development program and clinical trials for LymphoStat-B is suitable to support regulatory approval," said Sally D. Bolmer, PhD, RAC, senior vice president, regulatory affairs. "The SPA agreement is the latest example of the positive and productive interactions HGS has had with the FDA throughout the development of this product, including its designation as a fast track product, its selection for participation in the Pilot 2 program, and the excellent guidance we received during our end-of-phase II meeting."

HGS previously disclosed 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, including the primary efficacy endpoint, target patient population, and dose selection. HGS designed the program in collaboration with GlaxoSmithKline (GSK) and leading international SLE experts.
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