Research News

CAMPATH® Shows Promise in the Treatment of MS
Results of several pilot studies with the drug Campath (alemtuzumab) were presented at the annual American Academy of Neurology (AAN) meeting in Honolulu on April 1, 2003. Professor Alastair Compston, chairman of neurology at Addenbrooke’s Hospital in Cambridge, England, gave the presentation on Campath’s effects on MS, which he and his colleagues have been studying for more than 10 years.

According to a press release from ILEX™ Oncology Inc. (marketers of Campath), Professor Compston reports that a five-day course of Campath suppressed disease activity for a “prolonged period” in 36 individuals with secondary-progressive MS (SPMS). In a separate study, 17 individuals with early, active relapsing-remitting MS (RRMS) who had no progression or severe disability, experienced a nearly complete reduction in annualized relapse rate. Disability did not increase in any of the 17 RRMS participants.

In an abstract from the AAN meeting, Campath is described as a humanized monoclonal antibody that depletes T-cells. Campath is given annually, via five intravenous infusions, one per day for five consecutive days. This is a potent anti-cancer drug; for this reason, steroids are given during the treatment period to reduce the risk of a flare-up in symptoms.

According to the abstract, disability continued to progress in the 36 SPMS patients receiving Campath. They did, however, experience a suppressed relapse rate for a mean average of seven years. While it has been reported to strongly suppress inflammatory activity in SPMS, Campath does not appear to affect established progression, axonal degeneration (nerve cell death), and cerebral atrophy (permanent damage within the brain).

Participants with RRMS saw a reduction in relapse rate from a mean average of three relapses per year to point-one (.1, or one-tenth of one relapse) per year. In the following year, only one of the 22 treated individuals with RRMS experienced a relapse. The mean average of progression improved, starting with an increase in disability of two-point-four (2.4) Kurtzke Expanded Disability Status Scale (EDSS) points in the year prior to treatment, to a point-five (.5) EDSS point reduction in disability (in other words, participants had less disability after one year in the study compared to when they began).

Similar to the present approved treatments for MS, using Campath very early in the course of this disease may prove to be the time when this drug is the most effective in terms of reducing inflammation, as well as potentially preventing early cell death and the onset of progression. This theory has yet to be proven, however, and additional study results are needed before Campath’s effectiveness in treating MS can be confirmed.

Graves’ disease developed in approximately one-third of the patients. (Graves’ disease is a treatable thyroid condition, and with the knowledge that this is a potential consequence of the medication, clinicians may now be proactive by looking for and providing treatment at the first sign of subclinical Graves’ disease activity.) No significant adverse effects relating to infection were reported. Rash and itchiness were reported as side effects, which subsided through the use of an antihistamine such as Benadryl®.

Ilex has begun a three-year, phase II study comparing low-dose and high-dose Campath treatments to high-dose Rebif treatments in 150 patients with early, active RRMS. This study is being conducted at approximately 35 sites in the United States and Europe. Some of the sites in this country have yet to recruit participants. To be eligible, individuals must have early RRMS (less than three years) and have never been on any immunotherapy for MS other than steroids, along with meeting the other inclusion and exclusion criteria.

For more information about this study, please refer to www.ilexonc.com/ CAMMS223.htm for a listing of entry criteria and specific study locations. Information may also be found at www.clinicaltrials.gov. Anyone without access to the internet may call MSAA’s Helpline at (800) 532-7667 for assistance.