nsewell
Posted: Mon Mar 13, 2006 9:47 pm Post subject: liquid med study
I just got an email from a doc at Mayo Clinic about a study that is going on right now. She said it involves a liquid medicine that bind the toxins. Have any of you heard of this yet?
christina
Posted: Tue Mar 14, 2006 9:14 am The drug is called Tolevamer.They are doing a clinical trial her in Ohio as well.It works in the way that Questran does.
nsewell
Posted: Tue Mar 14, 2006 6:04 pm
I just talked to Patty from the Mayo clinic. She said its called G267. There is no name for it right now since it is in trials. She also said since its a blind study right now we dont even know if Id get that or Vanco or the FLagyl! I said whats the difference of going there and getting put on Vanco or taking it here like I am, she said nothing really, you d just get it free for 10 days. Have to be of Vanco for 5 days before going there, Scary! I think i will try the pulsing first.
christina
Posted: Tue Mar 14, 2006 7:18 pm
Here is a link to gt267 also called Tolevamer.
http://www.wrongdiagnosis.com/e/enteroc ... trials.htm
Tolevamer
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jskvt
- Regular User
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This is a Q&A on tolevamer, just sent out by a PR firm representing Genzyme Corporation. Genzyme is performing the trial on tolevamer.
As this was mass-distributed to members of the media via email by a publicist and is not a copyrighted publication, it is therefore legal to reproduce. I personally do not have any further information; Genzyme's website is www.genzyme.com.
About tolevamer
What is tolevamer?
Tolevamer is a novel, non-antibiotic toxin-binding compound being developed by Genzyme for the treatment of Clostridium difficile-associated diarrhea (CDAD). The investigational treatment is in phase 3 clinical development, and, if approved by regulatory authorities, could be the first non-antibiotic therapy approved to treat this infectious disease.
How does tolevamer work?
Infection with C. difficile leads to the production of toxins in the intestinal tract that cause inflammation and diarrhea. Tolevamer is designed to bind with these toxins and remove them from the body.
How is tolevamer different from other treatments for C. difficile-associated diarrhea?
Currently, the principle treatments for CDAD are the antibiotics metronidazole and vancomycin. While these treatments can be effective, they also reduce the levels of healthy bacteria in the intestine which can increase the risk of disease recurrence. Tolevamer does not damage the normal colon bacteria, so it is not expected to contribute to the risks of disease recurrence and drug resistance.
Why is tolevamer’s non-antibiotic approach important?
A non-antibiotic approach to CDAD treatment is important for two key reasons:
• Antibiotic therapies can reduce levels of healthy bacteria that provide a natural protection against the proliferation of C. difficile. Non-antibiotic tolevamer is designed so that it does not alter the normal, protective bacteria in the intestines, which is expected to reduce the risk of disease recurrence.
• Antibiotic resistance continues to represent a significant global health problem, especially in the hospital environment. Many hospital-acquired infections, including C. difficile, are becoming resistant to even the most powerful antibiotics. In fact, more than 70% of the bacteria that cause hospital-acquired infections are resistant to at least one of the drugs most commonly used to treat them.1 Limiting antibiotic use and identifying non-antibiotic treatment alternatives for hospital infections are important strategies to help curb this problem.
How will a patient take tolevamer treatment?
The dose and regimen for tolevamer is still under investigation. In the phase 3 trials, a standard 3 gram tolevamer dose is administered in approximately three tablespoons of an orange-flavored, ready-to-drink solution. Patients in the clinical trials are taking three doses per day for 14 days. Treatment is beginning with an initial dose of 9 grams at the first signs of CDAD. If approved, it is expected that patients would be given tolevamer for the first time in the hospital. Once they are discharged, patients would take the remainder of therapy on an out-patient basis.
What have clinical studies of tolevamer shown thus far?
In Genzyme’s phase 2 clinical study, tolevamer demonstrated similar treatment outcomes as vancomycin in terms of time to resolution of diarrhea, and a strong trend toward a reduced recurrence rate of CDAD.
What future studies are planned?
Genzyme is currently conducting phase 3 clinical studies of tolevamer, which are expected to be completed by mid-2007. The trials, which involve more than 1,000 patients at 300 sites in North America, Europe, and Australia, are the largest of their kind ever to be conducted for CDAD. In these trials, tolevamer is being compared to metronidazole and vancomycin. Aside from testing tolevamer’s efficacy, these are also the first large, rigorously designed, multi-center clinical studies that will compare the efficacy of the current standards of care.
How much will treatment cost?
The price of tolevamer has not yet been determined.
When will tolevamer be available?
Pending regulatory review, tolevamer potentially could be approved in 2008 in the United States and the European Union. It would be available as a prescription pharmaceutical product.
As this was mass-distributed to members of the media via email by a publicist and is not a copyrighted publication, it is therefore legal to reproduce. I personally do not have any further information; Genzyme's website is www.genzyme.com.
About tolevamer
What is tolevamer?
Tolevamer is a novel, non-antibiotic toxin-binding compound being developed by Genzyme for the treatment of Clostridium difficile-associated diarrhea (CDAD). The investigational treatment is in phase 3 clinical development, and, if approved by regulatory authorities, could be the first non-antibiotic therapy approved to treat this infectious disease.
How does tolevamer work?
Infection with C. difficile leads to the production of toxins in the intestinal tract that cause inflammation and diarrhea. Tolevamer is designed to bind with these toxins and remove them from the body.
How is tolevamer different from other treatments for C. difficile-associated diarrhea?
Currently, the principle treatments for CDAD are the antibiotics metronidazole and vancomycin. While these treatments can be effective, they also reduce the levels of healthy bacteria in the intestine which can increase the risk of disease recurrence. Tolevamer does not damage the normal colon bacteria, so it is not expected to contribute to the risks of disease recurrence and drug resistance.
Why is tolevamer’s non-antibiotic approach important?
A non-antibiotic approach to CDAD treatment is important for two key reasons:
• Antibiotic therapies can reduce levels of healthy bacteria that provide a natural protection against the proliferation of C. difficile. Non-antibiotic tolevamer is designed so that it does not alter the normal, protective bacteria in the intestines, which is expected to reduce the risk of disease recurrence.
• Antibiotic resistance continues to represent a significant global health problem, especially in the hospital environment. Many hospital-acquired infections, including C. difficile, are becoming resistant to even the most powerful antibiotics. In fact, more than 70% of the bacteria that cause hospital-acquired infections are resistant to at least one of the drugs most commonly used to treat them.1 Limiting antibiotic use and identifying non-antibiotic treatment alternatives for hospital infections are important strategies to help curb this problem.
How will a patient take tolevamer treatment?
The dose and regimen for tolevamer is still under investigation. In the phase 3 trials, a standard 3 gram tolevamer dose is administered in approximately three tablespoons of an orange-flavored, ready-to-drink solution. Patients in the clinical trials are taking three doses per day for 14 days. Treatment is beginning with an initial dose of 9 grams at the first signs of CDAD. If approved, it is expected that patients would be given tolevamer for the first time in the hospital. Once they are discharged, patients would take the remainder of therapy on an out-patient basis.
What have clinical studies of tolevamer shown thus far?
In Genzyme’s phase 2 clinical study, tolevamer demonstrated similar treatment outcomes as vancomycin in terms of time to resolution of diarrhea, and a strong trend toward a reduced recurrence rate of CDAD.
What future studies are planned?
Genzyme is currently conducting phase 3 clinical studies of tolevamer, which are expected to be completed by mid-2007. The trials, which involve more than 1,000 patients at 300 sites in North America, Europe, and Australia, are the largest of their kind ever to be conducted for CDAD. In these trials, tolevamer is being compared to metronidazole and vancomycin. Aside from testing tolevamer’s efficacy, these are also the first large, rigorously designed, multi-center clinical studies that will compare the efficacy of the current standards of care.
How much will treatment cost?
The price of tolevamer has not yet been determined.
When will tolevamer be available?
Pending regulatory review, tolevamer potentially could be approved in 2008 in the United States and the European Union. It would be available as a prescription pharmaceutical product.
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Christina
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