ILEX Oncology & LeukoSite report results from pivotal Phase II CAMPATH (R) trial; Results suggest new hope for refractory chronic lymphocytic leukemia

ausing bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen. Standard front line therapy consists of alkylating agent based drug regimens. Fludarabine is the only approved drug for the treatment of patients who have failed alkylating agents. No approved therapy is available for patients who fail fludarabine therapy.

CAMPATH appears to work in CLL by depleting malignant CLL cells, which bear the CD52 antigen. CAMPATH is a humanized monoclonal antibody which is directed against the CD52 antigen found on normal and malignant lymphocytes, on normal macrophages and monocytes, but has not been detected on hematopoietic stem cells.

CAMPATH therapy is associated with significant lymphopenia. The lymphopenia resolves in some, but not all, patients over weeks to months after cessation of CAMPATH therapy.

"Early studies suggested the promise of CAMPATH. This study appears to confirm the decision to submit a BLA to the FDA," said Kanti R. Rai, M.D., Chief, Division Hematology-Oncology, Long Island Jewish Medical Center. "CAMPATH may very well become the next new and promising monoclonal antibody therapy for patients with cancer. For our patients with CLL, CAMPATH may change the expectation from one of relentlessly progressive deterioration on palliative therapies to the hope of extended survival," said Dr. Rai, who is also one of the trial's principal investigators and an internationally recognized expert in CLL.

ILEX and LeukoSite are developing CAMPATH through a joint venture that was established in May 1997. Clinical trials in the treatment of non-Hodgkin?s lymphoma, CLL, and other malignancies expressing CD52 are being planned.

"CAMPATH is the most advanced of ILEX's nine compounds and we are anxious to make it available to patients," said Richard L. Love, president and chief executive officer of ILEX.

ILEX Oncology, Inc. is a drug development company focused exclusively on accelerated development of drugs fo

Contact: Deborah Sibley, ILEX Oncology
Porter Novelli

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