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Ligand's ONTAK to be Evaluated in Treatment of Patients with Chronic Lymphocytic Leukemia

Wake Forest University School of Medicine Initiates Physician Trial
SAN DIEGO--(BW HealthWire)--Jan. 18, 2001--Ligand Pharmaceuticals Incorporated (Nasdaq: LGND - news) today announced that the Comprehensive Cancer Center of the Wake Forest University School of Medicine in Winston-Salem, NC has initiated the first formal evaluation of ONTAK® (denileukin diftitox) in patients diagnosed with fludarabine-refractory, CD25-positive, B-cell chronic lymphocytic leukemia (CLL). Objectives for this physician Phase II clinical trial will be to determine the complete and partial response rate, to assess the toxicity profile, and to examine the period of progression-free survival and overall survival following treatment with ONTAK in patients with CLL refractory to treatment with fludarabine. Arthur Frankel, M.D., Professor of Medicine and Cancer Biology at the Cancer Center, is the principal investigator in the trial.

According to Dr. Frankel, ``We believe that the full clinical utility of ONTAK is yet to be realized. As a novel fusion protein with a unique mode of action and a low incidence of immunosuppression (9% of patients), evaluation of this agent in several different malignancies is warranted.'' Regarding CLL, Dr. Frankel went on to say, ``This is an important area where new therapies are needed. ONTAK may provide useful benefits.''

Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL), which affects a reported 7,800 new patients each year in the US, is the most common adult leukemia in the Western Hemisphere and accounts for about 25% of all leukemias. CLL is, to-date, an incurable disease. Patients with progressive disease traditionally have been treated with fludarabine and/or other cytotoxic agents, but ultimately patients treated with fludarabine relapse and become refractory to subsequent treatments. Therefore, identification and evaluation of new agents with utility in the treatment of CLL is necessary to change the natural course of this disease.

``Patients with progressive CLL, especially as they become unresponsive to current therapy, are a vexing problem,'' said Marshall Lichtman, M.D., executive vice president, research and medical programs, for The Leukemia & Lymphoma Society. ``The study of a possible additional approach to such patients is always welcome. The results of studies of ONTAK will be awaited with anticipation by patients and their families threatened by progressive CLL.''

ONTAK® in CLL

ONTAK, previously known as DAB389IL-2, is a novel, targeted, cytotoxic biologic. By employing the IL-2 subunit, the cytotoxic diphtheria toxin is delivered only to cells that express the IL-2 receptor (IL-2R). Since IL-2R may be expressed in a variety of malignant cells, including CLL, current expert opinion strongly suggests that CLL is another potential indication for the use of ONTAK. ONTAK was chosen for evaluation of its anti-leukemic activity on the basis of clinical activity against CLL demonstrated earlier by a related, but less potent, predecessor molecule, DAB486IL-2. In addition, ONTAK has previously demonstrated effectiveness and safety in treating patients with another low-grade lymphoma, cutaneous T-cell lymphoma (CTCL). The FDA approved ONTAK in February 1999 for the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the IL-2 receptor.

Ligand Pharmaceuticals Incorporated

Ligand Pharmaceuticals Incorporated discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, and men's and women's hormone-related diseases, as well as osteoporosis, metabolic disorders and cardiovascular and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology, primarily related to Intracellular Receptors (IRs) and Signal Transducers and Activators of Transcription (STATs).

This news release may contain certain forward-looking statements by Ligand which involve risks and uncertainties and reflect Ligand's judgement as of the date of this release. Actual events or results may differ from Ligand's expectations. There can be no assurance that final results will be similar to those results seen in earlier clinical trials or that such results will be supportive of regulatory approvals required to market ONTAK for CLL. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available via Ligand's website at http://www.ligand.com. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release.

Full prescribing information for Ligand's products may be obtained in the U.S. from Ligand Professional Services by calling toll free 800-964-5836 or on Ligand's web site at http://www.ligand.com.

Ligand Pharmaceuticals' releases are available on the World Wide Web at www.businesswire.com/cnn/lgnd.htm.


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Contact:

Ligand Pharmaceuticals Incorporated
Christiane V. Sheid, Vice President Finance &
Communications
858/550-7809