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news.Protalix BioTherapeutics has released positive preliminary data from the first 15 patients that completed the company's nine month, worldwide, multi-center, open-label, switchover trial of taliglucerase alfa for the treatment of gaucher disease.
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Taliglucerase alfa is under review by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Action (PDUFA) date scheduled for 25 February 2011.
The data from the trial suggested that the patients can safely be switched to Taliglucerase alfa from imiglucerase (Cerezyme).
In the trial, the patients enrolled were switched from imiglucerase (doses ranging from 10-60U/kg every other week) to an equivalent dose using the same number of units of Taliglucerase alfa.
The data from the first 15 patients demonstrate that maintenance of efficacy was achieved over a nine month period with no increased safety concerns.
Protalix president and CEO David Aviezer said that they are pleased with the interim results of the switchover trial to Taliglucerase alfa.
"Through our Phase III pivotal and extension trial, pediatric study in naïve patients, switch-over trial, expanded access and named patient programs, ATU program in France and supply agreement in Brazil, we are generating a robust clinical database for taliglucerase alfa," Aviezer said.
The switchover trial was originally designed and cleared by FDA to enroll 15 patients, however, it was expanded to recruit a total of 30 patients as a result of the shortage of enzyme replacement therapy for gaucher patients.