How soon might the FDA approve Tolevamer sodium for c. diff (CDAD) ?

Hello stopwhining,

  I'm afraid Vancomycin will continue to be the drug of choice for
C.diff infections for another year or so!

"Following discussions with the FDA regarding the Phase 2 data,
Genzyme plans to commence Phase 3 study activities of tolevamer in the
second half of 2004, and to begin enrolling patients in early 2005"
http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=600016

Since Phase 3 clinical trials will begin early 2005, you can expect to
see approval about a year after the trials conclude. (If the FDA likes
what it sees!) See the third chart on Page 4:
http://www.genzyme.com/corp/media/nasdaq_article.pdf



"Genzyme Corporation Announces Positive Results from Phase 2 C. difficile Trial
October 20, 2003
Genzyme Corporation announced positive results from a preliminary
analysis of data from the Phase 2 clinical trial of tolevamer sodium,
an investigational polymer therapy for patients with Clostridium
difficile associated diarrhea (CDAD). Final data will be presented at
a medical conference next spring. The Phase 2 trial enrolled 289
patients at 58 sites in the United States, Canada and the United
Kingdom in a randomized, double blind, active-controlled study
designed to determine the safety and effectiveness of tolevamer sodium
capsules at two dose levels (6 grams and 3 grams), versus the standard
prescribed oral dose of the antibiotic vancomycin. Preliminary data
show tolevamer met this endpoint at the 6 gram dose level and was
found to be similar to vancomycin in median days to resolution of
diarrhea (2 days for vancomycin patients and 2.5 days for patients
with the 6 gram dose of tolevamer) and demonstrated a risk ratio
relative to vancomycin of 0.98 (95% CI: 0.68 -1.41)."
http://news.moneycentral.msn.com/ticker/sigdev.asp?Symbol=GENZ

Regards, Crabcakes

If this is not the answer you were seeking, please ask for an Answer
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Search Terms

tolevamer + FDA approval + C.difficile + 2005

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Request for Answer Clarification by stopwhining-ga on 07 Feb 2005 07:53 PST

HI crabcakes,

In regard to this tolevamer question, I know Genezyeme is in the Phase
3 stage of their research with this product to fight c. diff. I want
to find out how we can apply to participate in this phase? Genezyeme
is aquiring patients now but I have not recieved any calls back from
them in my attempt to get this question answered. I will continue to
try, but can you help?

Thanks,
stopyerwhining

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Clarification of Answer by crabcakes-ga on 07 Feb 2005 13:31 PST

Check this webpage for contact information... perhaps it's different than yours.
http://www.genzyme.com/home/contact_us.asp

or

http://www.genzyme.com/research/clinical_trials/clinical_home.asp#other

To e-mail

http://www.genzyme.com/home/send_email.asp?to=partners

Perhaps these will help. Do they have YOUR contact information?
Usually a doctor needs to be involved - has your doctor contacted
Genzyme?

Regards, Crabcakes

Very complete answer. Very helpful. Will use service again, I'm sure.  Many thanks.