PDL Halts Second Protovir Trial

15 September 1996

Protein Design Labs has halted its second clinical trial of Protovir (MSL 109) after an interim analysis showed "a lack of evidence of efficacy." The company was advised to halt its first study of the anticytomegalovirus antibody for CMV retinitis at the end of last month (Marketletter September 2).

While the earlier Phase II/III study in newly-diagnosed or relapsed disease found no efficacy, it also found evidence of an excess mortality in the Protovir-treated group. The excess was mainly observed in those who had relapsed. The latest study was conducted only in newly-diagnosed patients, and found no such increase in mortality compared to placebo.

Higher Dose To Be Tested? The new study was conducted by the AIDS Clinical Trials Group, which has recommended that the study continue using a higher dose of the antibody, in order to establish if it has any efficacy. A third trial investigating whether Protovir can prevent CMV retinitis in patients undergoing bone marrow transplantation is still in progress.

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