Preliminary Results from Phase 2 Genzyme Study Highlight Potential of Novel Oral Compound for Gaucher Disease
Wednesday, May 07, 2008 2:01 PM
Symbols: GENZ

CAMBRIDGE, Mass., May 7 /PRNewswire-FirstCall/ -- Genzyme Corp.(Nasdaq: GENZ) reported today that a preliminary analysis of data from anongoing open-label Phase 2 clinical trial of its investigational oral therapyGenz-112638 showed that the compound produced a meaningful impact on keyclinical manifestations of Gaucher disease. The results highlight thepotential of this compound to become an innovative treatment option forGaucher disease.


Genzyme's Cerezyme(R) (imiglucerase for injection), the standard of carefor patients with Type 1 Gaucher disease, is administered through intravenousinfusions. The company is developing Genz-112638, a capsule taken orally, toprovide a convenient treatment alternative for patients and to provide abroader range of treatment options for physicians.


The primary analysis period of the Phase 2 study of Genz-112638 isscheduled to conclude later this year, and the results for all trialparticipants will be available in the first quarter of 2009. The studyincluded 26 adults with Type 1 Gaucher disease at medical centers in NorthAmerica, South America, Europe and Israel. It was designed to evaluate theefficacy, safety and pharmacokinetics of the compound over one year. Nearlyall study participants had completed six months of treatment when thepreliminary analysis was conducted, and approximately half of the participantshad completed one year of treatment.


The preliminary analysis showed that Genz-112638 produced promisingefficacy results at six months and that these results continued to improvethrough one year of treatment:


    -- At six months, spleen volumes had decreased from baseline by a mean of       27 percent among the 21 patients for whom data were available.  Spleen       volumes had decreased by 40 percent among 11 patients with available       data at one year.
-- At six months, hemoglobin levels had increased from baseline by a mean of 0.9 grams per deciliter of blood among 17 patients for whom data were available. Hemoglobin levels had increased by 1.3 grams per deciliter among 13 patients with available data at one year.
-- Platelet counts increased from baseline by a mean of 18 percent among 17 patients treated for six months and by 34 percent among 13 patients with available data at one year.
-- Chitotriosidase levels decreased from baseline by a mean of 30 percent at six months among 20 patients and by 50 percent among 12 patients treated for one year.

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