NEWSWORTHY AND USEFUL

January 20, 2005

Clinical Trial Enrollments

Clinical Trial Enrollments

Patients aged 50 years or older with mild to moderate Alzheimer disease (AD) may be eligible to enroll in a clinical trial that is testing a drug aimed at the biology-- not the symptoms--of the devastating disease. The phase 3 trial for 3-amino-1- propanesulfonic acid, commercially known as Alzhemed, opened last summer, but some of the 70 planned trial sites were still recruiting patients in late 2004. Alzhemed targets beta-amyloid, a protein fragment that is believed to cause damage to nerve cells. "What's exciting about Alzhemed is that it works directly on the amyloid protein," said Barry Rovner, MD, director of Clinical Alzheimer's Research, Farber Institute for Neurosciences, at Thomas Jefferson University in Philadelphia. He and his colleagues at Jefferson began enrolling patients in November. Alzhemed, under development by Neurochem Inc. in Laval, Quebec, is an organic molecule administered orally. Its purpose is to prevent formation and deposit of amyloid fibrils in the brain and to inhibit the inflammatory response associated with amyloid buildup. "The hope is that it stabilizes the course of the disease, modifying its progression. It's aimed at what is thought to be the central problem in the disease," said Rovner, who told Applied Neurology that he chose to participate in the study because "no others [current therapies] have this kind of advanced action." In a phase 2 trial, Alzhemed appeared to be able to cross the blood-brain barrier, indicating its ability to act on amyloid. In addition to being 50 or older and having mild to moderate AD, patients in the 70- week, 950-patient trial must be living within a community, with assisted living at most, and not in a nursing home. Other centers around the United States and in Canada that are recruiting for the trial can be found on the NIH's clinical trials Web site at

http://www.clinicaltrials.gov/ct/show/NCT00088673?order=1

. Eli Lilly & Co. launched a new Web site in December that opened up some of the company's clinical trials information to the public, including trials Lilly is seeking patients to join. These trials include the company's potential treatments for bipolar disorder, schizophrenia, and depression. You can see these at:

http://www.lillytrials.com/recruiting/recruiting_cns.html

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New FDA Approvals

Multiple Sclerosis

. A new drug, natalizumab, approved in November by the FDA, apparently works against multiple sclerosis (MS) because it binds to errant immune system cells and prevents them from getting to the brain and causing damage. Commercially, the drug is known as Tysabri and is manufactured by Biogen Idec and distributed by Elan Pharmaceuticals. Tysabri is administered by injection once a month in a doctor's office, and its wholesale price has been reported to be more than $1800 per dose. It is the first of its kind of drug approved for treating patients with relapsing forms of MS. It is bioengineered from part of a mouse antibody but closely resembles human antibody. The FDA approved natalizumab, a monoclonal antibody, after seeing positive results after only 1 year of treatment in 2 ongoing clinical trials. In the 942-patient AFFIRM trial, the drug produced a 66% reduction in frequency of relapses versus placebo. In the 1171-patient SENTINEL trial, it yielded a 54% reduction in relapse frequency versus placebo when it was used in combination with interferon beta-1a (Avonex, another Biogen Idec therapy already approved for MS treatment).

Pain.

In November, the FDA approved Combunox, a fixed-dose combination of oxycodone HCl (5 mg) and ibuprofen (400 mg), for the treatment of acute, moderate to severe pain. The tablet is manufactured and marketed by Forest Laboratories under license from BTG. A primary use of Combunox is for treatment of pain that patients experience after surgery or injury.