as expected, "socko"...... TD...... links expire, and this is a reference thread........
Friday February 22, 9:15 am Eastern Time
Study finds Immunex's Enbrel works for psoriasis
By Deena Beasley
LOS ANGELES, Feb 21 (Reuters) - Enbrel, the rheumatoid arthritis drug made by Immunex Corp. (NasdaqNM:IMNX - news), was effective in more than half of psoriasis patients treated for six months in a mid-stage clinical trial, researchers said.
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The Phase II study of 112 patients, which will be presented on Tuesday at a meeting of the American Academy of Dermatology in New Orleans, found that 56 percent of patients treated with Enbrel had at least a 75 percent improvement in their psoriasis over six months compared to 5 percent of patients on placebo.
``These results are socko. A 75 percent drop ... means these people are wearing shorts and swimsuits and feeling good about themselves,'' said Dr. Alice Gottlieb, professor of medicine at the Robert Wood Johnson Medical School in New Brunswick, New Jersey, and the study's presenter.
She noted that the Enbrel trial was not designed to look at how long the disease remissions would last.
Enbrel, on the market since 1998 as a treatment for rheumatoid arthritis, was approved by the U.S. Food and Drug Administration last month as the first treatment for psoriatic arthritis, a disease that involves joints and skin.
Psoriasis is a chronic skin disease that affects more than seven million Americans, according to the National Psoriasis Foundation. It occurs when skin grows faster than normal and old skin is not shed quickly enough, causing inflamed, swollen and scaly patches. Drugs now most commonly used to treat psoriasis -- cyclosporine or methotrexate, can lead to kidney or liver damage with repeated use.
Since psoriasis strikes many people when they are young adults, it is seen as a lucrative market for biotech firms that could potentially sell their drugs to patients for decades.
Gottlieb said side effects seen most frequently in the Enbrel trial were mild upper respiratory infections.
Patients with moderate to severe psoriasis were injected twice a week for six weeks with either Enbrel or placebo. Thirty percent of Enbrel patients achieved the trial's primary goal of a 75 percent improvement at three months.
NEW DRUGS TARGET INFLAMMATORY RESPONSE
Enbrel works by inactivating a protein linked to inflammation. Like arthritis, psoriasis seems to be a disorder in which a person's immune cells attack his own body.
Seattle-based Immunex, which is being acquired by the No. 1 biotechnology company Amgen Inc. (NasdaqNM:AMGN - news) reported 2001 Enbrel sales of $762 million and Amgen projects sales will reach $3 billion by 2005.
Immunex has said it plans to eventually file for U.S. Food and Drug Administration (FDA) of Enbrel for treatment of psoriasis, but the drug is already being used ``off-label'' for that purpose. ``I have already written 15 prescriptions for Enbrel for my psoriasis patients,'' Gottlieb said.
Other companies are also developing new psoriasis drugs. Another biologic arthritis treatment, Johnson & Johnson's
(NYSE:JNJ - news) Remicade, which is given intravenously, also looks promising for psoriasis, Gottlieb said.
A separate clinical trial she is presenting at the dermatology conference shows that half the psoriasis patients given three infusions of Remicade maintained their response six months after treatment, the researcher said.
Biogen Inc. (NasdaqNM:BGEN - news) filed last year for U.S. and European approval of its experimental psoriasis drug, Amevive, which is designed to selectively target a subset of T-cells. The drug can be given by injection or intravenously.
Amevive induces long-lived remissions, but two sets of doses are needed to get to a 50-percent response level, Gottlieb said.
Genentech Inc. (NYSE:DNA - news) has said it plans to file a marketing application with the FDA this summer for Xanelim, an antibody designed to block certain immune cells from entering and binding to skin tissue. Once Xanelim, which is self-administered subcutaneously, is out of a patient's system, relapse occurs, so patients would need ``a once-a-week bolus pretty much forever,'' the researcher said. |
