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Phase II study of an oral therapy for Gaucher disease yields positive results
Date:5/3/2010

re hoping an oral alternative would be viable," said lead study author Elena Lukina, MD, of the Hematology Research Center at the Russian Academy of Medical Sciences in Moscow, Russia.

The study endpoint (improvement in at least two of the three main efficacy parameters: spleen volume, hemoglobin level, and platelet count) was met by three-fourths (77%) of all patients and nearly all (91%) of the 22 patients who completed the full 52 weeks, with the greatest overall improvements seen in hemoglobin level and spleen volume. The research team found statistically significant improvements across many disease symptoms, including mean hemoglobin level, platelet count, spleen volume, liver volume, and lumbar spine bone mineral density. Furthermore, the patients' glucosylceramide plasma levels normalized. Disease symptoms seemed to respond rapidly, and improvement was seen especially in bone mineral density. This may have resulted from the drug's small molecular size, which allows it to diffuse quickly within affected cells.

"Eliglustat tartrate provides promise for a safe, effective, and convenient oral therapy for patients with Gaucher disease type 1," said Dr. Lukina.

Further clinical development of eliglustat tartrate is already proceeding with larger, controlled Phase III studies in untreated patients and in patients previously stabilized with imiglucerase an intravenously administered medication currently used to treat Gaucher disease.


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Contact: Wendy Stokes
webmaster@hematology.org
202-776-0544
American Society of Hematology
Source:Eurekalert

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