Drug Could Represent New Paradigm by Eradicating Inflammatory Process
Tuesday January 7, 8:01 am ET
Source: ILEX Oncology Inc
[Details of the Campath Trial can be found at:
ILEX(tm) Oncology Inc. has begun a Phase II trial to evaluate CAMPATH® (alemtuzumab) -- known as MABCAMPATH® in the European Union -- versus Rebif® (interferon beta-1a) in patients with early, active relapsing-remitting multiple sclerosis (R/R MS).
The randomized, open-label study will compare CAMPATH with Rebif for efficacy in preventing sustained accumulative disability.
CAMPATH may have the potential to slow or stop progression of disability in MS. In numerous studies, CAMPATH has clearly demonstrated the ability to target and substantially deplete the inflammatory T-cells that are considered to play a pivotal role in initiating the cascade of events eventually leading to MS disease progression.
A pilot study has already demonstrated that a five-day course of CAMPATH suppressed disease activity for a prolonged period in 40 patients with secondary, progressive MS. In another CAMPATH pilot study involving 15 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.
Data from these studies were submitted to the American Academy of Neurology for presentation at the organization's annual meeting in March 2003.
"Our preliminary results in the treatment of early, active MS are very encouraging," said Professor Alastair Compston, chairman of neurology at Addenbrooke's Hospital in Cambridge, England, where the use of CAMPATH in MS patients has been pioneered for more than 10 years, and principal investigator of the multi-center phase II study. "So far, every patient has shown a predictable response. We now need to confirm that CAMPATH does indeed represent a major advance in the treatment of MS by suppressing disease activity and therefore preventing disability."
The randomized, open-label study is sponsored by ILEX and will compare the efficacy of CAMPATH to Rebif in time to sustained accumulation of disability (SAD) in MS patients. Rebif is a licensed treatment for MS in the United States, UK and in much of Europe. The study will include approximately 150 patients at 20 centers in the United States and Europe. The study's co-principal investigator is Kenneth Johnson, MD, at the Maryland Center for MS in Baltimore.
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.
Schering AG, Germany (FSE:SCH) (NYSE:SHR - News) holds exclusive worldwide marketing and distribution rights to CAMPATH. The product is marketed in the U.S. by Berlex Laboratories Inc., a U.S. affiliate of the Schering AG Group. CAMPATH was launched in the U.S. in June 2001, and in Europe, where it is named MABCAMPATH, in August 2001.
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 300,000 Americans acknowledge having MS, and every week about 200 new cases are diagnosed in the U.S.
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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