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The research pipeline for psoriasis

Psoriasis research is in the midst of an exciting boom that offers much hope for people with psoriasis. Right now, more than 40 experimental drugs are being tested for the treatment of psoriasis and/or psoriatic arthritis. Activity and interest in this field of research are at an all-time high.

Psoriasis is receiving unprecedented attention from drug and biotechnology companies, in part because researchers can take one look at the psoriasis on your arm and tell whether their experimental drug works.

Granted, not all of the experimental treatments will make it to the market. On average, the FDA takes a year to review drugs and biologics submitted for approval. Only two, discussed below, have been submitted to the U.S. Food and Drug Administration (FDA) for approval. But enough will succeed to revolutionize treatment of psoriasis.

Many of the experimental treatments listed in the National Psoriasis Foundation research pipeline chart are not traditional pharmaceutical drugs. While pharmaceutical drugs are artificially created by combining inorganic (non-living) chemicals, several emerging psoriasis therapies are derived from living sources, such as viruses, animals and people.

These new agents are called "biologic drugs," and while it may be unsettling to imagine receiving an injection of a drug fused together from human and mouse DNA, for instance, this is the future of psoriasis treatment. Unlike their chemically created counterparts, biologics have to be injected or infused into the body, rather than taken orally. These new drugs target very specific parts of the immune response, so in theory they could be more effective and have fewer side effects than existing drugs.

Biotechnology (rather than pharmaceutical) companies, which are responsible for these new agents, began cropping up in the early 1980s, as our understanding of basic biologic processes, such as DNA expression, took major strides.

What's coming out first

For example, alefacept (brand name Amevive), which Biogen submitted to the FDA in August 2001, is a fusion protein designed to block a misstep in the immune system"the activation of T cells. Activated T cells fuel the development of psoriasis lesions by causing skin cells to develop and mature at an accelerated rate. Amevive (pronounced AM-uh-veev) may be available to consumers by late 2002 or the first quarter of 2003.

Etanercept (brand name Enbrel) was the first treatment approved for psoriatic arthritis. Developed by Amgen and Wyeth-Ayerst Laboratories, the FDA approved Enbrel in January 2002 for the treatment of psoriatic arthritis. In psoriatic arthritis, TNF-alpha is present in increased levels, which causes inflammation and can lead to tissue and joint damage. Enbrel works by inhibiting inhibits tumor necrosis factor-alpha (TNF-alpha), an immune-system chemical messenger. Enbrel is also in development for the treatment of psoriasis.

Infliximab (brand name Remicade), a drug similar to Enbrel, is also currently being tested for the treatment of psoriasis and psoriatic arthritis. Developed by Centocor, Remicade was approved for Crohn's disease in 1998 and for rheumatoid arthritis in 1999. Remicade is given by IV infusion in a doctor's office over 2-4 hours. A small phase II trial of Remicade in psoriasis patients was recently completed, and Centocor plans to move forward with a phase III trial to compare the safety and effectiveness of Remicade alone versus no treatment (placebo) in psoriasis patients.

Genentech, which is moving toward FDA approval for its psoriasis treatment efalizumab (brand name Raptiva, formerly Xanelim) was the first biotechnology company. Biogen was established shortly after, in 1978. Biogen recently submitted the biologic agent alefacept (brand name Amevive) to the FDA for approval for the treatment of psoriasis.

These companies and their products are regulated by a different branch of the FDA than traditional drugs—the Center for Biologics Evaluation and Research (CBER). According to CBER, a biologic is "any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings."

Raptiva and Amevive fall within that definition. Both molecules incorporate human DNA so they can slip under our immune system's radar without being marked as "foreign." Once inside, they block immunesystem reactions that lead to the formation of psoriasis lesions. Stay tuned to the Bulletin and the NPF Web site for updates on these drugs as they progress on their way to FDA approval.

Phases of Drug Development

• Preclinical: Extensive laboratory and animal testing by companies to determine biological activity and safety.
• Investigational New Drug (IND) application: Describes results of preclinical testing; filed by companies with the FDA prior to initiating testing in people. The IND becomes effective if the FDA does not reject it within 30 days.
• Phase I clinical trials: In this phase of a clinical trial, the manufacturer wants to find out how the drug works in healthy study participants. Mode of action (how the drug exerts its effects), safety and side effects are some of the main issues examined. It is important to note that in phase I studies, the overall safety of the medication in patients has not been established.
• Phase II: A drug reaches phase II only when the FDA has reviewed the phase I data and concludes the drug is safe for patients, and its clinical activity may be beneficial against a particular disease or condition. At this point, a larger group of patients is enrolled and rating scales specific to a condition or disease are used to record data.
• Phase III: At this point, the medication is ready to be studied in a larger population, with even more advanced rating scales and clinical measures. In recent years, there has been a growing industry trend to not only measure clinical effectiveness at this phase, but also measure "real world" results; for example, how patients' activities of daily living are improving.
• Phase IV: At this phase in development, the drug has already been granted FDA approval. Phase IV studies are often performed to either identify an additional use for an already approved drug or to gather additional safety information from a larger group of patients. Phase IV studies are implemented to establish effectiveness in a subgroup of patients, such as patients over age 65.
• New Drug Application (NDA): Filed with the FDA after completion of human clinical trials. An NDA usually contains hundreds of thousands of pages of scientific information and clinical data.