Biopharma takes aim at lupus
Friday, Aug. 18, 2006
by Steve Berberich
Staff Writer
A handful of Maryland bioscience companies are at the forefront of developing a treatment for lupus, a mysterious disease that attacks the immune systems of up to 2.5 million Americans.
And experts say that unlocking the key to lupus treatments could result in therapies for other autoimmune diseases, such as rheumatoid arthritis.
Human Genome Sciences Inc. of Rockville announced last week it has geared up for what would be the largest lupus study ever, experts say. The phase 3 clinical trials will test its antibody treatment LymphoStat-B in patients with systemic lupus, a severe form of lupus that afflicts several hundred thousand Americans.
Meanwhile, MedImmune Inc. of Gaithersburg and MacroGenics of Rockville are also working on treatments, while the National Institutes of Health in Bethesda is running nationwide trials of stem cell treatments for lupus.
‘‘It used to be that companies wondered if there would be a market for lupus,” said Sandra C. Raymond, president and CEO of the Lupus Foundation of America.
It’s been 40 years since the U.S. Food and Drug Administration approved a new lupus treatment, she said.
However, ‘‘companies are beginning to see a profit” ahead, Raymond said, as science unravels the underlying causes of lupus and commercial and federal research funding has been increased. The National Institutes of Health’s funding for lupus studies has reached about $90 million.
Why the immune system suddenly turns against healthy tissues in the body of a lupus patient is still largely a mystery, but the disease is linked to the malfunction of plasma B cells that make infection-fighting antibodies. Lupus patients have a wide variety of symptoms, making it difficult for physicians to diagnose the disease, Raymond said.
‘‘Stepped-up research has almost brought us to the brink of breakthrough,” she said. Because lupus is ‘‘the prototypical autoimmune disease,” finding effective treatments will lead to more knowledge of rheumatoid arthritis, a better known autoimmune condition, she said.
To help pay for its phase 3 trials of LymphoStat-B, Human Genome Sciences will receive $24 million from GlaxoSmithKline of the United Kingdom under a prior co-development agreement.
The trials will likely involve more than 1,600 patients, the largest study in the history of lupus research, according to George Tsokos, a professor of medicine at Walter Reed Army Medical Center in Washington, D.C., who has researched lupus for 25 years.
‘‘I think [LymphoStat-B] shows promise and they are to be praised and for doing this study,” Tsokos said of HGS.
He is moving his own study of the role of lymphocytes on lupus to a laboratory at Harvard Medical School, where patients will also take part in the HGS trials, he said. Once the company gets the FDA’s go-ahead, trials will be conducted at several clinics worldwide, said company spokesman Jerry Parrott.
Anthony Coyle, a researcher at MedImmune, says the tide has turned in lupus research from finding treatments for symptoms to going after the underlying causes of the disease.
Coyle, the company’s senior director of research and the head of inflammation biology, is leading studies of an antibody that could treat lupus by inhibiting certain interferons.
In April, MedImmune began a phase 1 trial of its MEDI-545, which it licensed two years ago from Medarex Inc. of Princeton, N.J.
‘‘Over the last two or four years, we realized there is a very interesting relationship,” Coyle said. ‘‘Much of the pathology in lupus is related to this.”
Beyond the clinical trials, MedImmune’s antibody could help researchers keep tabs on ‘‘bio-markers” that would indicate the severity of lupus, Coyle said.
MedImmune and Tsokos are also looking into a family of natural enzymes called chitinases that may be an important therapeutic target in a number of inflammatory and other diseases. MedImmune has acquired rights to the enzymes from Yale University.
MacroGenics has partnered with the NIH-funded Immune Tolerance Network to develop an antibody that may have therapeutic benefits in a wide range of autoimmune diseases, including systemic lupus, ulcerative colitis and psoriasis.
In pre-clinical studies, MacroGenics scientists are investigating whether any of its lead antibody drugs would be effective in ‘‘limiting the pathogenicity” of lupus, said Scott Koenig, CEO and president. One of the company’s leading candidates is in trials to fight juvenile diabetes and shows signs that it may do well in later trials against autoimmune diseases.
‘‘We have products which have good potential now for going after lupus but we have not made a decision on them yet,” said Stanley R. Pillemer, vice president for clinical research and product safety.
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