New Multi-Center Trial Underway to Evaluate Role of ILEX's CAMPATH in MS
April 2, 2003
Source: ILEX Oncology Inc.
At the American Academy of Neurology meeting in Honolulu yesterday, Professor Alastair Compston, chairman of Neurology at Addenbrooke's Hospital in Cambridge, England, presented clinical data from several pilot studies of the drug CAMPATH(R) (alemtuzumab) in multiple sclerosis (MS).
Professor Compston and his colleagues have been studying CAMPATH in MS for more than 10 years.
Professor Compston reported that results from one pilot study at Addenbrooke's Hospital showed a five-day course of CAMPATH suppressed disease activity for a prolonged period in 36 patients with secondary, progressive MS. In another CAMPATH pilot study involving 17 patients with early, active relapsing-remitting MS without progression or severe disability, the group had a near complete reduction in annualized relapse rate, and in no patient did disability increase.
"Our preliminary results in the treatment of early, active MS are very encouraging," Professor Compston told attendees. "To date, every patient has shown a predictable response to CAMPATH through suppressed disease activity. We are now participating in an important clinical trial to confirm these impressive results."
The randomized, open-label Phase II study began in December 2002. It is comparing the safety and efficacy of CAMPATH to Rebif(R) (interferon beta-1a) in preventing sustained accumulative disability in patients with early, active relapsing-remitting MS. The study will include 150 patients at 35 centers in the United States and Europe.
CAMPATH was granted accelerated approval by the U.S. Food and Drug Administration in May 2001 for the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alklylating agents (anti-cancer drugs that inhibit tumor growth by interfering with the DNA of cancer cells) and have failed fludarabine (a chemotherapy agent) treatment.
Multiple sclerosis (MS) is a disease in which inflammation damages the myelin sheath and underlying nerve fibers in the brain and spinal cord. It affects as many as 2.5 million people worldwide. The cause and pathogenesis of MS are poorly understood. Although the course of MS is not predictable, the disease often moves from a phase of relapses with remission to a state of persistent neurological symptoms and signs followed by slow progression, at which point disability becomes increasingly apparent. MS is approximately twice as common among women as men, with peak incidence usually occurring between the ages of 30 and 40. More than 350,000 Americans acknowledge having MS, and every week about 200 new cases are diagnosed in the United States.
Founded in 1994 as an oncology drug development company, ILEX is strategically positioned to become a product-driven oncology-focused biopharmaceutical company. ILEX has a marketed product, CAMPATH, in the United States and MABCAMPATH in the European Union, and is advancing an innovative and diversified pipeline of compounds focused on the treatment of cancer. The ILEX pipeline comprises product candidates at various stages of clinical development, including cytotoxic and cytostatic agents with novel mechanisms of action, monoclonal antibodies, angiogenesis inhibitors and signal transduction inhibitors. ILEX maintains a core competency in oncology drug development, with locations in San Antonio, Texas, and Guildford, England. ILEX also conducts research in angiogenesis inhibition, cell signaling, medicinal chemistry and nuclear receptor biology at its laboratories in Boston, Mass., and Geneva, Switzerland. Further information about ILEX can be found on the company's Web site at www.ilexonc.com.
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in ILEX's compounds under development in particular; the potential failure of ILEX's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of ILEX's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change ILEX's business, structure or projections; the development of competing products; uncertainties related to ILEX's dependence on third parties and partners; and those risks described in ILEX's Form 10-K for the year ended Dec. 31, 2001, and in other filings made by ILEX with the SEC. ILEX disclaims any obligation to update these forward-looking statements.
SOURCE: ILEX Oncology Inc.
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