Targretin Gel Achieved 86% Response Rate in Early-Stage CTCL Patients Treated for More Than One Year, Researchers Report At AAD Meeting.

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SAN DIEGO--(BW HealthWire)--Feb. 28, 2002

Results for Targretin(R) Capsules in Sezary Syndrome,

Panretin(R) Gel in Kaposi's Sarcoma also Presented

More than 85% of patients with early-stage cutaneous T-cell lymphoma (CTCL) who were treated for at least one year with Targretin(R) gel (bexarotene gel 1%) responded to treatment, according to results of a study presented in a poster session at the annual meeting of the American Academy of Dermatology this week in New Orleans.

"The results of this study are very encouraging for patients with early-stage CTCL, a disease that can be topically treated for years," said lead author Debra Breneman, MD, University of Cincinnati. "Targretin gel is a safe and effective long-term treatment without evidence of the risk of skin damage or secondary malignancy seen with other standard treatments. It offers a convenient, at-home, lesion-directed therapy."

The researchers analyzed data from patients treated for 12 months or more in previous studies. Of 117 patients enrolled in these studies, 43 were treated for more than one year, with a median treatment period of 29.6 months. Of the 43 patients, 38 had multiple prior treatments for CTCL, and 30 were refractory or intolerant to at least one of the treatments. Thirty-seven of the 43 patients (86%) responded positively (greater than or equal to 50% improvement by a Physician's Global Assessment (PGA)), including 12 who achieved clinical complete clearing (CCR). Targretin gel was generally well tolerated. Adverse events occurring in 5% or more of patients included skin irritation, itching, redness, burning and pain, and were primarily confined to the application site.

Ligand also is conducting a 50-patient Phase I-II study for Targretin gel in hand dermatitis; interim results are expected in 2002.

Targretin Capsules Improve Symptoms of Sezary Syndrome in 63-Year-Old Patient

In a second poster presentation, Mayo Clinic researchers reported case results of a 63-year-old man with stage IVA CTCL with Sezary syndrome, the leukemic and most aggressive subtype of CTCL. Sezary syndrome normally carries a poor prognosis. The patient had been treated previously with multiple therapies over the eight-year history of his disease. During treatment with Targretin, the patient was evaluated monthly for efficacy and side effects. Targretin capsules therapy improved significantly the patient's symptoms, and afforded him an additional 10 months of disease remission. Peripheral Sezary cell counts were documented on a 10-point scale; improvement of redness, itching and scale was noted during a 16-week trial period. Treatment was continued for 40 weeks, and was stopped when the condition abruptly reflared. In this patient, the only side effect noted during the trial was hyperlipidemia, which was well controlled with fenofibrate.

Panretin(R) Gel in Combination with Liposomal Doxorubicin Improves Symptoms of Kaposi's Sarcoma

In a third poster presentation, researchers demonstrated an overall response rate of 67% (greater than or equal to 50% improvement as measured by PGA) in a multi-center, open-label, Phase IV study of patients with AIDS-related Kaposi's sarcoma treated with a combination of topical Panretin gel (alitretinoin) and intravenous liposomal doxorubicin. Twenty-one patients were enrolled, and 14 (67%) responded. Of these 14, three achieved CCR, and two were greater than or equal to 90% clear. In addition, 12 of the 13 (92%) patients who completed the 16-week study responded to the combination treatment. Adverse events related to Panretin gel were generally mild to moderate and included transient pain and irritation at the application site. This study represents a potentially important alternative in KS therapy, the authors said.

The posters presented at the AAD Conference were:

-- P229 Long-Term Treatment of Patients with Early-Stage Cutaneous T-Cell
Lymphoma with Bexarotene Gel 1%. Debra Breneman, MD, University of Cincinnati,
Cincinnati, OH; Madeleine Duvic, MD, MD Anderson Cancer Center, Houston, TX;
Ann Martin, MD, Washington University School of Medicine, St. Louis, MO;
Richard Yocum, MD, Ligand Pharmaceuticals Inc., San Diego, CA.

-- P224 Oral Bexarotene (Targretin) for the Treatment of a Patient with Therapy
Resistant Sezary Syndrome. Saskis A. Bouwhis, MD, and Rokea A. el-Azhary, MD,
PhD, Mayo Clinic, Rochester, MN.

-- P482 The Combination of Topical Alitretinoin Gel Plus Liposomal Doxorubicin
Appears Safe and Effective as Treatment for AIDS-Related Cutaneous Kaposi's
Sarcoma. Victor Stevens, PhD, Ligand Pharmaceuticals Inc., San Diego, CA;
Anthony LaMarca, MD, TheraFirst Medical Centers, Fort Lauderdale, FL; Rebecca
Miller, MD, Private Practice, Los Angeles, CA; Marcus Conant, MD, Research Unit
of Marcus Conant, MD, San Francisco, CA.

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Ligand Pharmaceuticals Incorporated discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, skin diseases, men's and women's hormone-related diseases, 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.

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