AEGiS-GMHC: Treatment Briefs: KS Drug Goes to FDA

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Treatment Briefs: KS Drug Goes to FDA

Treatment Issues, Volume 12, Number 5 - May 1998
Dave Gilden

Ligand Pharmaceuticals has filed a request for FDA approval of Panretin gel (9-cis retinoic acid) as a topical treatment for Kaposi's sarcoma. The submission is based on two 12-week phase III trials. In one conducted in North America, 35% of those applying Panretin gel showed some improvement in index KS skin lesions compared to 18% of those applying a placebo. The response rate in this 268-person trial increased to 49% during an open-label extension phase of the trial. In an international trial, the 12-week response rates were 42% and 7% for Panretin versus placebo.

In a further analysis of the North American data, Ligand found that the response rate was independent of the strength of concurrent anti-HIV therapy. This is a major issue since many opportunistic infections improve after people switch to highly active antiretroviral therapy -- see the article on NTZ and cryptosporidiosis in this edition of Treatment Issues.

A French study published in the May 7 edition of the journal AIDS looked at the effect of initiating protease inhibitor therapy in nine persons with HIV-related KS. In eight of the nine, lesion clearance or regression occurred along with reduction in levels of the KS herpes virus. But 74% of the participants in the Panretin North American trial were taking protease inhibitors, including 82% in the placebo arm. Panretin's benefit appeared regardless of antiretroviral therapy.

Ligand is also developing a capsule form of 9-cis retinoic acid for systemic KS therapy. In a phase II trial reported in May at the annual meeting of the American Society of Clinical Oncology, an intent-to-treat analysis found a 37% response rate after 16 or more weeks of treatment. Equivalent results were obtained in another phase II trial, which was presented at the AIDS Malignancy Conference in April. The oral and topical formulations may have had the same results in these trials, but Ligand argues that the capsules will be easier to use for persons with large numbers of KS lesions. Oral Panretin also may be effective against KS in internal organs, although this remains to be demonstrated.

An open-label phase I/II trial that combines Panretin capsules with alpha interferon therapy is now ongoing. Ligand plans to ask the FDA for permission to market the oral version sometime next year.

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