April 22, 2004 07:00 AM US Eastern Timezone

ILEX Fully Enrolls CAMPATH Multiple Sclerosis Study; Global Investigator and Patient Interest in Trial Leads to Rapid Accrual 

SAN  ANTONIO--(BUSINESS WIRE)--April 22, 2004--ILEX(tm) Oncology Inc. (Nasdaq:ILXO) announced today that it has met its enrollment target of 240 patients in its global, multi-center Phase II trial of CAMPATH(R) (alemtuzumab) in previously untreated relapsing/remitting multiple sclerosis (MS). The Company announced in January that it was expanding the size of the trial from 150 patients to 240 patients based on growing interest among investigators and patients, as well as repeated recommendations of the independent data safety monitoring board to continue the study.

"The rapid accrual of this CAMPATH MS trial highlights the great demand for new therapeutic options in the MS arena," said study investigator and community neurologist Edward Fox, M.D., Ph.D., in Austin, Texas. "We're looking forward to seeing some preliminary data towards the end of the year."

The randomized, open-label study is investigating CAMPATH and Rebif(R) (interferon beta-1a) for effectiveness in delaying the sustained accumulation of disability in previously untreated relapsing/remitting MS patients. In previous independent pilot and investigator-sponsored studies, CAMPATH appeared to demonstrate the ability to target and substantially deplete the inflammatory T-cells that are considered to play a pivotal role in early stage MS.

In a CAMPATH pilot study reported at the 2003 American Academy of Neurology annual meeting by Professor Alastair Compston, chairman of neurology, University of Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom, 17 previously untreated patients with early, active relapsing-remitting MS without progression or severe disability experienced a near-complete reduction in annualized relapse rate, and in no patient did disability increase.

CAMPATH is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces, leading the body's immune system to deplete B- and T-cells that are instrumental in the pathogenesis of MS. 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 alkylating agents and have failed fludarabine treatment.

About CAMPATH

CAMPATH is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces, leading the body's immune system to destroy malignant cells and deplete B- and T-cells that are instrumental in disease. 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 alkylating agents (anti-cancer drugs that inhibit tumor growth by interfering with the DNA of cancer cells) and have failed fludarabine (a chemotherapy agent) treatment.

The most commonly reported infusion-related adverse events were rigors, fever, nausea, vomiting and hypotension. Hematologic toxicities included pancytopenia/marrow hypoplasia, anemia, thrombocytopenia and neutropenia and should be monitored. Infections reported included sepsis, pneumonia and opportunistic infections such as CMV, candidiasis, aspergillosis and mucormycosis.

Schering AG, Germany (NYSE:SHR) (FSE:SCH) holds exclusive worldwide marketing and distribution rights to CAMPATH. The product is marketed in the United States by Berlex Laboratories, a U.S. affiliate of the Schering AG Group. CAMPATH was launched in the United States in June 2001, and in Europe, where it is named MABCAMPATH(R), in August 2001.

About ILEX

Founded in 1994 as an oncology drug development company, ILEX is strategically positioned to become a product-driven biopharmaceutical company, focused primarily in oncology. ILEX has a marketed product, CAMPATH(R) in the United States and MABCAMPATH(R) 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. In February 2004, ILEX announced its agreement to merge with Genzyme Corporation, a global biotechnology company. The merger, subject to ILEX stockholder approval and other customary conditions, is expected to close in mid-2004. 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; market acceptance of CAMPATH(R); the ability to expand the number and scope of the indications for which CAMPATH(R) is approved; 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 ability of ILEX to predict its future expenses and capital needs; the development of competing products; uncertainties related to ILEX's dependence on third parties and partners; and those risks described in ILEX's report on Form 10-K filed on March 12, 2004, and in other filings made by ILEX with the SEC. ILEX disclaims any obligation to update these forward-looking statements.

Original article can be found here