Navigation Links
Genzyme Announces First Phase III Study of Tolevamer in Diarrhea Patients

Genzyme Corp. announced top-line data 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 alarming rise in the incidence of disease, higher numbers of patients with complications and more frequent failures of standard antibiotic therapy.

Tolevamer is designed to bind and neutralize the toxins released by C. difficile that damage the intestine. A non-antibiotic approach has the potential to treat CDAD and reduce the number of disease recurrences, resulting in improved quality of life for the patient and significant savings to the healthcare system.


'"/>




Related medicine news :

1. Ramdoss Announces Introduction of RCH-II
2. Britain Announces Third Transfusion Related Mad Cow Case
3. Tibet Announces the Dalai Lama’s Tour of South Americ
4. Indian PM Announces Of Setting Up India Study Center At Tashkent
5. PowderMed Announces Needle-Less Flu Vaccine
6. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
7. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
8. Australian Government Announces Survey To Tackle Childhood Obesity
9. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
10. Apollo Announces Research on Indian Cardiac Epidemic
11. Government Announces Steps To Promote Ayurvedic Medicine
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/22/2017)... ... , ... Gevir, a New Zealand-based company that focuses on developing powder and ... to Amazon.com, the world’s largest online retailer. , The company was founded ... natural treatment for Shelley’s Multiple Sclerosis, which she’d been diagnosed with at 28 years ...
(Date:2/22/2017)... ... 2017 , ... South Bend’s Lunkerville, the award-winning TV series that catches real ... Water (HOW), a non-profit organization dedicated to helping military veterans relax, rehabilitate, and reintegrate ... traveling to Lake Denmark, New Jersey, to fish with war veteran Justin Vail from ...
(Date:2/22/2017)... Los Angeles, CA (PRWEB) , ... February 22, 2017 , ... ... with the recent addition of esteemed ophthalmologist, Dr. Steven H. Rauchman, practicing at ... are common in auto accidents, product liability, premise liability and other personal injury cases. ...
(Date:2/22/2017)... ... ... ANGLESTRONG , the new recovery management app with multiple innovative features ... and Google Play . Florida-based Sober Network, Inc., the premier provider of ... Angle to build ANGLESTRONG. The new recovery management app is a passion project for ...
(Date:2/22/2017)... (PRWEB) , ... February 22, 2017 , ... ... communications company, launched a new media platform connecting healthcare technology professionals and other ... be followed by a quarterly publication starting on March 1, announced Michael J. ...
Breaking Medicine News(10 mins):
(Date:2/22/2017)... 22, 2017 Research and Markets has ... Pipeline Review, 2016" report to their offering. ... Dermatological conditions ... and approximately one-third of the US population suffers from at ... majority of the dermatology market has remained saturated with established ...
(Date:2/22/2017)... and PUNE, India , February ... report published by Allied Market Research, titled, "Radiology Information System ... Opportunity Analysis and Industry Forecast, 2014-2022," the radiology information system ... projected to reach $941 million by 2022, growing at a ... information systems segment held over three-fifths share of the total ...
(Date:2/22/2017)... , February 22, 2017 ... the Dow Jones Industrial Average, and the S&P ... out of nine sectors ended Tuesday,s trading session ... sentiment, Stock-Callers.com assessed the following Medical Instruments & ... (NASDAQ: TNDM), C. R. Bard Inc. (NYSE: BCR), ...
Breaking Medicine Technology: