A Non-Antibiotic Approach to Deal with Clostridium difficile associated diarrhea
Apr 4, 2005, 21:43, Reviewed by: Dr.
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"Tolevamer is being developed as a much-needed alternative to antibiotics to treat this devastating and sometimes fatal infection that now affects thousands of people each year. We are encouraged by data that indicate that tolevamer may be particularly valuable in reducing recurrence and repeat hospitalization for these patients."
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By Genzyme Corporation,
Genzyme Corporation (Nasdaq: GENZ) announced today that physicians have treated the first patients in a Phase 3 clinical study to test the safety and efficacy of tolevamer, an investigational polymer therapy for patients with Clostridium difficile associated diarrhea (CDAD), a form of infectious diarrhea caused by the bacterium C. difficile.
Tolevamer is being developed as a new, non-absorbed therapy that could be the first non-antibiotic treatment approved for CDAD. Tolevamer is designed to bind and remove from the body 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.
C. difficile is a spore-forming bacterium that is found widely in the environment and is known to survive for months in hospitals and long-term care facilities. Patients are at risk of developing CDAD when they are treated with antibiotics that alter the normal, protective bacteria that reside in the colon. Virtually all antibiotics have been implicated in causing CDAD and the
number of reported cases of CDAD infections has increased in recent years.
"C. difficile represents a significant risk to many hospital and long-term care patients, especially among the elderly," said Georges Gemayel, executive vice president of Genzyme Corp."Tolevamer is being developed as a much-
needed alternative to antibiotics to treat this devastating and sometimes fatal infection that now affects thousands of people each year. We are encouraged by data that indicate that tolevamer may be particularly valuable in reducing recurrence and repeat hospitalization for these patients."
The Phase 3 study will be conducted at more than 250 clinical sites in North America, Europe and Australia, and involve more than 1,000 patients. Enrollment is expected to take approximately eighteen months to complete.
The randomized, double-blinded study will include three arms and have a primary endpoint of non-inferiority to the standard prescribed oral dose of the antibiotic vancomycin, measured by the percent of patients with resolution
of CDAD. Half of the patients enrolled in the study will receive tolevamer in a new liquid formulation designed for ease of use.
The study also will evaluate tolevamer against metronidazole, the most commonly prescribed antibiotic treatment for CDAD. In addition, because tolevamer is a non-antibiotic and will not harm the normal protective intestinal bacteria that prevent C. difficile proliferation, it is expected to reduce the rate of recurrent CDAD. The study is also designed to measure the
superiority of tolevamer based on the number of CDAD recurrences against both vancomycin and metronidazole.
Tolevamer has been evaluated in five clinical studies to date, including a large Phase 2 efficacy study, two open-label clinical trials in CDAD patients, a Phase 1 trial in healthy volunteers and an additional Phase 1 tolerability
study evaluating the new liquid formulation. Data from this last study show the new liquid formulation of tolevamer to be well-tolerated at all dosing levels tested up to a maximum of 15 grams. The daily dose of tolevamer in the Phase 3 study is 9 grams. The results from the Phase 1 study are being presented this week at the European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen.
Genzyme has become a worldwide leader in developing polymer-based therapies for serious diseases, including Renagel(R) (sevelamer hydrochloride) and WelChol(R) (colesevelam hydrochloride). In each case, the polymers are designed to provide clinical benefit by binding and removing unwanted
substances from the body.
Clostridium difficile is the most common cause of infectious, hospital-based diarrhea and, although incidence is not officially tracked, may result in more than 400,000 cases of diarrhea and colitis annually in the United States, leading to death in about 5,000 cases.
C. difficile proliferates in the setting of altered normal colonic bacterial flora, most commonly due to the administration of broad-spectrum antibiotics. Once established in the colon, C. difficile produces toxins that
disrupt the intestinal lining, causing cell death and inflammation that result in diarrhea and colitis.
Vancomycin is currently the only therapy approved by the U.S. Food and Drug Administration for treatment of CDAD. Even after successful treatment with the current standard of care, approximately 20 percent of patients experience a recurrence of CDAD which may require repeat hospitalization.In addition, a subset of patients with CDAD develop multiple recurrences of the disease, with symptoms that may persist for years. 
- The results from the Phase 1 study are being presented this week at the European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen.
Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Founded in 1981, Genzyme has grown from a small start-up to a diversified enterprise with annual revenues exceeding $2 billion and more than
7,000 employees in locations spanning the globe. With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation
continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need.
This press release contains forward-looking statements, including the statements regarding the possibility that tolevamer could be the first non-antibiotic therapy approved for CDAD, tolevamer's potential to reduce recurrence, improve quality of life and provide significant savings to the healthcare system, the increasing rate of CDAD worldwide, the magnitude of the health risks associated with CDAD, the need for alternative treatments and the value that could be associated with such a treatment, the number of sites expected to participate in the Phase 3 trials, the number of patients to be
enrolled in the trial, the time it will take to conduct the trial, the expectation that the design of the trial will demonstrate certain information, the current rate of CDAD recurrence and the ability of tolevamer therapy to
reduce CDAD recurrence, and expectations relating to the effect tolevamer will have in the intestine. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those
projected in these forward-looking statements. These risks and uncertainties include, among others, the uncertainties associated with conducting clinical trials, including the time it may take to conduct the trial and the ability of
the trial design to demonstrate certain results; the regulatory approval process in the United States and foreign countries for new drug products; competitive product development; the accuracy of Genzyme's information
concerning the market for tolevamer therapy, including growth projections; the competitive environment; the costs associated with treating CDAD and its recurrence; the off-label use of antibiotics to treat CDAD; the ability to
obtain and maintain patent or other proprietary intellectual property protection and the actual impact of those patents and rights; and the risks and uncertainties described in reports filed by Genzyme with the Securities
and Exchange Commission under the Securities Exchange Act of 1934, as amended,including without limitation the information under the heading "Factors Affecting Future Operating Results" in the Management's Discussion and
Analysis of Financial Condition and Results of Operations section of the Genzyme Annual Report on Form 10-K for the year ending December 31, 2004.
Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no
obligation to update or revise the statements.
Renagel(R) is a registered trademark of Genzyme. WelChol(R) is a registered trademark of Sankyo Pharma, Inc.
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