Ligand And ALRT; Retinoids Progress

Joint-venture company Allergan Ligand Retinoid Therapeutics has started a Phase III clinical trial of ALRT1057 Topical (9-cis-retinoic acid) for the treatment of Kaposi's Sarcoma, the first pivotal evaluation of a topical therapy in KS.

The US Food and Drug Administration cleared the pivotal study based on positive results for 20 of 78 patients enrolled into Phase I/II studies (Marketletter October 16, 1995). Following the disclosure of additional results last week, data are now available on the first 43 patients participating in the clinical trials.

In these trials, the drug has been able to satisfy at least one AIDS Clinical Trial Group criterion for partial response in one or more treated lesions in 30% of cases, compared with 9% for the non-treated control lesions. Breaking down this data, it was found that 4.5% of treated lesions showed a complete response while 11 patients (26%) taking active drug met partial response criteria (a complete flattening of at least 50% of raised treated lesions). On the basis of these results, the product will now be entered into a Phase III trial for KS.