Navigation Links
Genzyme Announces Data from First Phase 3 Study of Tolevamer in,Patients with C. difficile Associated Diarrhea

CAMBRIDGE, Mass., July 06, 2007 /PRNewswire-FirstCall/ -- Genzyme Corp. announced top-line data today from the first of two Phase 3 clinical studies to assess the safety and efficacy of tolevamer liquid, an investigational, non-antibiotic, polymer therapy for patients with Clostridium difficile associated diarrhea (CDAD). The second Phase 3 study of tolevamer liquid is fully enrolled and results are expected later this year.

In this first Phase 3 study known as the Polymer Alternative for CDAD Treatment (PACT) study, tolevamer liquid did not meet its primary endpoint of non-inferiority to the standard prescribed oral dose of the antibiotic vancomycin, as measured by the percent of patients with resolution of CDAD. This result contrasts with the findings from Genzyme's earlier Phase 2 study of a solid oral dosage formulation of tolevamer that met its primary endpoint of non-inferiority compared to vancomycin.

Consistent with recent published studies, high rates of CDAD recurrences were observed in patients treated with either vancomycin or metronidazole. High CDAD recurrence rates were not observed in patients treated with tolevamer liquid. Tolevamer liquid was generally well tolerated with no unanticipated safety concerns. Data from this first Phase 3 study is expected to be presented at a future medical conference.

"These are disappointing results that alter our expectations about the potential for commercializing tolevamer in the near future," stated Henri A. Termeer, chairman and chief executive officer of Genzyme Corp. "The results of our second Phase 3 study will be available later this year and will help us determine what contribution tolevamer might be able to make in addressing this serious unmet medical need."

C. difficile has become one of the most significant infection control concerns in healthcare today. Physicians worldwide are confronting a worsening epidemic, with an
'"/>




Page: 1 2 3 4

Related medicine technology :

1. Genzyme Announces Results of Clinical Trial of Hylastan
2. Genzyme Announces Results of Clinical Trials Investigating Powder Form of Sevelamer Carbonate
3. Genzyme Announces Results of Clinical Trials Investigating Powder Form of Sevelamer Carbonate
4. Genzyme and Bayer HealthCare Announce Detailed Interim Two-Year Alemtuzumab in Multiple Sclerosis Data Presented at AAN
5. Genzyme Announces Successful Completion of Study Investigating Sevelamer Carbonate in Patients With Chronic Kidney Disease
6. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
7. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
9. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
10. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
11. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis

Post Your Comments:
(Date:11/25/2009)...--RegadoBiosciences,aprivatelyheldcompanyleadingth...rolagents,announcedthatDavidMazzo,PhD,CEOandPresid...lthCareConferenceattheNewYorkPalaceHotelinNewYorkC...onTuesday,December1andwillincludeanoverviewoftheCo...gram,theanticoagulantsystem,REG1.Thehealthcareindu...
(Date:11/25/2009).../--SwissrayInternational,Inc.aleadingmanufacturero...odaythatitsoperationshavebeenacquiredbyaprivateSwi...smedicalimagingbrand.Theacquisitionincludedallasse...ntory.After25yearsofsuccessandgrowthSwissrayisnowp...tswithstableandsteadygrowth. ,, "Swissrayhaslon...
(Date:11/25/2009)...nker.comannouncesthatanewmarketresearchreportisava...y-USMarketTrends&Analysis http://www.reportli...rket-Trends--Analysis.html ,, TheUSintranasald...ticapplicationsfromthedeliveryofconventionallocalt...rugs.Thefutureofthetechnologyhingesontotheeffectiv...
Breaking Medicine Technology:Regado Biosciences to Present at the Piper Jaffray 21st Annual Health Care Conference on December 1, 2009 2Swissray International Announces New Ownership 2Reportlinker Adds Intranasal Drug Delivery - US Market Trends & Analysis 2Reportlinker Adds Intranasal Drug Delivery - US Market Trends & Analysis 3Reportlinker Adds Intranasal Drug Delivery - US Market Trends & Analysis 4Reportlinker Adds Intranasal Drug Delivery - US Market Trends & Analysis 5Gamida Cell and Cellerix Partner on Feasibility Study 14558 1Gamida Cell and Cellerix Partner on Feasibility Study 14558 2Gamida Cell and Cellerix Partner on Feasibility Study 14558 3NASCSA Receives 24200 000 Grant From Purdue Pharma L P to Support State Prescription Drug Monitoring Programs 5633 1NASCSA Receives 24200 000 Grant From Purdue Pharma L P to Support State Prescription Drug Monitoring Programs 5633 2Shire Targets Fourth Quarter Filing of BLA for REPLAGAL 28R 29 for Fabry Disease With U S FDA 5629 1Shire Targets Fourth Quarter Filing of BLA for REPLAGAL 28R 29 for Fabry Disease With U S FDA 5629 2Shire Targets Fourth Quarter Filing of BLA for REPLAGAL 28R 29 for Fabry Disease With U S FDA 5629 3Shire Targets Fourth Quarter Filing of BLA for REPLAGAL 28R 29 for Fabry Disease With U S FDA 5629 4
(Date:11/25/2009)... grew out of a collaboration between UCLA engineer...he nearly 10 million Americans who suffer from per...rdening of the arteries, peripheral arterial disea...ch narrowed arteries reduce blood flow to the limb...ular disease, heart attack and stroke, and its pro...
(Date:11/25/2009)...too short to draw definite conclusions, experts sa...ws) -- In diabetic patients with blocked coronary ...comes at one year whether patients undergo bypass ...archers report. , Bypass surgery has been the s...ary artery disease. However, less invasive approac...
(Date:11/25/2009)...ation and treatment clinics to resume Monday, Nov....ovember 25, 2009 -- Centegra Health System is cont...ne shots at four Centegra Primary Care (CPC) vacci...as arrived. The clinics are at CPC sites in Huntle... open as follows: ,   From 4:30 to 7:3...
(Date:11/25/2009)...ological symptoms, study finds , , WEDN...de effects are among the potential problems faced ...re treated with cisplatin-based chemotherapy, a ne...orwegian men treated for unilateral testicular can...w-up survey conducted from 1998 to 2002. , The ...
(Date:11/25/2009)...re/-- MISSIONSkincare ®isproudtosupportGNC,se...NC,sannualSt.Jude ThanksandGiving campaign,$1fromt...ER-C(TM)LipBalm willbedonatedtoSt.Jude.Additionall...onationatcheckoutatoneoftheir5,000+retaillocations...Judeduringtheir2009 ThanksandGiving campaign. ,...
Breaking Medicine News(10 mins):Health News:Engineers, doctors at UCLA develop novel material that could help fight arterial disease 2Health News:Engineers, doctors at UCLA develop novel material that could help fight arterial disease 3Health News:Engineers, doctors at UCLA develop novel material that could help fight arterial disease 4Health News:Stenting May Equal Bypass for Diabetic Heart Patients 2Health News:Stenting May Equal Bypass for Diabetic Heart Patients 3Health News:Centegra H1N1 Vaccination Clinics to Resume Tuesday, Dec. 1 2Health News:Centegra H1N1 Vaccination Clinics to Resume Tuesday, Dec. 1 3Health News:Centegra H1N1 Vaccination Clinics to Resume Tuesday, Dec. 1 4Health News:MISSION Skincare(R) Supports GNC's Efforts To Raise Money for St. Jude Children's Research Hospital(R) 2
...y, contrast-enhanced sonography compared with sono...sessment of blunt abdominal trauma.// Massimo... objective of our study was to prospectively compa...ts”. The study was conducted by the departme...
...d about subject as sex is, perhaps vying with each...act of stress is well known - responsible //for ma...ecently stress during pregnancy was thought to lea...en seem to be twice inclined to suffer PSTD and de...
...ced that the deadly H5N1 strain of bird flu has be...ria, which is the first African// country to be hi...been reported, experts fear that several cases hav...es in Taraba, one commercial farm and two places w...
...c study says ‘significant fluctuations in the firs...ncreases// the chances of death’. According to...ying diastolic blood pressure, which again is root...24 hours. Blood pressures were checked every five ...
...nt of Energy's Pacific Northwest National Laborato...s that the damage in neurodegenerative diseases// ...led nitration. It was explained that Parkinson's, ...idative stress, the cell damage that is usually ca...
...els will sashay down the catwalk alongside eight b...s Assam city// . Preparations are on for the ...e ornate Pragjyoti cultural centre in Guwahati. Yo...ippanita Sharma for company that day. "The e...
Other Medicine News:Health News:New Tool Found to be Effective in Assessing Blunt Abdominal Trauma 2Health News:Fluctuating BP and Stroke Lowered Patient Survival Rate 2Health News:Scientist Optimistic In Breakthrough For Causes Of Neurodegenerative Diseases 2Health News:Blind Girl Students to Catwalk in Guwahati Fashion Show 2
Hemacarotid Knitted
Vasoseal Low Profile kit 2
..., and Maximum ACT introducers represent the larges...ucers in the world. They are recognized as the pre...nal cardiology and electrophysiology procedures in...ctomy, temporary pacing, endomyocardial biopsies, ...
Perclose A-T (Auto Tie)
Medicine Products: