Progress For Cypros With Cytoprotectants

Cypros Pharmaceutical (see also pages 26-27) has reported furtherresults from three of the six Phase II clinical trials of its cytoprotectant drugs CPC-111 and Ceresine (CPC-211. Additional dose testing in its CPC-111 bypass surgery trial and Ceresine closed head injury trial continue to support the drugs' safety and efficacy and the feasibility of launching Phase III trials in these indications by year's end. However, the CPC-111 angioplasty trial results have been inconclusive.

Cypros previously reported that CPC-111 had marked cardioprotective effects in a trial of 50 bypass surgery patients at a dose of 250mg/kg. The data reported last week were for a single intravenous dose of 125mg/kg, preoperatively, in 20 additional patients. The drug-treated patients showed improvements in heart function and reduced heart damage, but to a lesser degree than at the earlier dose. The company will therefore use 250mg/kg in future studies. Cypros has now enrolled 70 patients in this study and is currently evaluating a multidose protocol, with the drug given both pre- and post-operatively, before considering a Phase III protocol.

In the CPC-111 angioplasty trial the drug was well tolerated, but due to an insufficient level of heart damage, the effects of the drug were not evident versus placebo. These data are consistent with recently published clinical results which show that the cardioprotective effect of CPC-111 is most apparent in those patients with more severe impairment in heart function.