I want to know how we might apply for the Phase 3 portion of the trial
test through Genezyme with thier new product Tolovamer sodium. It is
suppose to begin early this year but I can't get anyone there to
return a phone call. Is there some protocol we can follow?
Thanks, stopyerwhining

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Request for Question Clarification by crabcakes-ga on 08 Feb 2005 20:39 PST

Hi stopwhining,
 I just now saw your question. I will work on this tomorrow, and post
when I have an answer for you!
 Thanks for being patient!

  :-)   Crabcakes

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Clarification of Question by stopwhining-ga on 09 Feb 2005 10:49 PST

Hi Crabcakes,

On my mother's behalf I want to know how she could become part of the
pool of patients who would receive Tolevamer sodium as part of the
Phase 3 portion of drug testing. Apparently this phase is the last
step before FDA marketplace approval and includes administiring this
drug to a given test group. This last test group are all assured of
actually receiving the drug and not a placebo. I believe this is a
nation wide test. I have called Genezyme, talked directly to "live
people" and have been promised return calls; of course none have been
placed.

As it stands we have exhausted all the current protocol and the
condition lingers still. It can be very dibilitating and in some cases
life threatening. We have an appointment with a new doctor on the 22nd
and I want to be able to give him information on this new drug in case
his unaware of its developement. My qusetion specifically is: How can
we get my mother into this test group so that she can try this new
drug?

I re-read my intial question; no wonder you needed clarification. That
was terrible! I hope this is better. If not, let me know.

Many thanks,
stopyerwhining 

PS. Any talk of putting a spell checker on this page? I could use it!

Hello again stopwhining,

  Thank you for asking for me... I apreciate it.

Genzyme does have a protocol for applying to their clinical trials.
You don't mention having filled out any forms. You will need to fax
them to Genzyme. If you don't have a fax machine, try your local
library and copy shops, most of which have them for a fairly
reasonable fee.

  Download and print  the following documents which you can take to
your doctor. Most trials have rather strict criteria for accepting
applicants to trial programs, which may be why you have not heard from
Genzyme. I?m unable to call  Genzyme on your behalf (though I would
love to do so!), as I don't know your mother's personal information or
medical history, and  more so because researchers are prohibited from
making personal contact with customers.

Below are several forms that Genzyme requires to be accepted for clinical trials.

About Tolevamer
http://www.genzyme.com/corp/licensing/genz_pdf_tolevamer_nonconfidential.pdf

Confidential Disclosure Agreement. Have you already faxed this to
Genzyme? "Please complete the CDA and fax to 617-768-9817  "
http://www.genzyme.com/corp/licensing/genz_pdf_CDA.pdf

This page indicates you will get more information about this trial
after you fax in the Confidential Disclosure agreement. Apparently
they will send you a logon name and password to log in. Be sute to
type in your e-mail address very carefully, so you can be sure and
receive e-mail from genzyme.
http://www.genzyme.com/corp/licensing/genz_p_tolevamer_login.asp

Is this the form you have already filled out? If not, please fill it
out and submit, and if so, perhaps doing it again would jar their
memory. Fill out and fax the forms above, and take them to your doctor
with you.
http://www.genzyme.com/home/send_email.asp?to=tolevamer


About clinical trials in general:
http://www.centerwatch.com/patient/backgrnd.html

In case your mother doesn?t get into the Genzyme trial, click on
Notification Services, on this page, and fill out the form. You can be
notified when another trial is upcoming.
http://www.centerwatch.com/

Please read this page:
http://www.hippocrates.com/archive/April2000/04features/04clinictrials.html

Your doctor may be interested in this article, free if s/he has a
subscription, $5 if not.
Toxin Binding of Tolevamer, a Polyanionic Drug that Protects against
Antibiotic-Associated...
Braunlin et al. Biophys. J..2004; 87: 534-539.
http://www.biophysj.org/cgi/content/full/87/1/534

An abstract can be read here:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=npg&cmd=Retrieve&db=PubMed&list_uids=15240486&dopt=Abstract

Take these articles to your doctor too:
Getting "C diff" under control
http://rnweb.com/rnweb/article/articleDetail.jsp?id=114135

Genzyme Presents Results From Phase 2 C. Difficile Clinical Trial
http://www.bio.com/industryanalysis/industryanalysis_news.jhtml?cid=600016

Steps in a clinical trial
http://www.phrma.org/newmedicines/newmedsdb/phases.pdf


Out of curiosity, has your mother already tried:
Metronidazole (Flagyl)
Rifampin
Vancomycin
Questran (Cholestyramine resin)
Intravenous human immunoglobulin (IVIG)
Probiotics, such as Lactobacillus GG, Lactobacillus acidophilus


Don't worry about not being clear... this happens to many people.
Sometimes what we write makes perfect sense to us, because we know
what we meant to say! In any case, I think I know what you want now!
As far as a spellchecker on Google Answers, that would be fabulous.
Most people are pretty good spellers, they, as am I, fumble-fingered
on the keyboard!

  

I hope this helps you and your mother out! Please request an Answer
Clarification, before rating, if any part of this answer is unclear.
Sincerely, Crabcakes

Search Terms
Genzyme clinical trials
Clinical trials

Crabcakes,
You did a great job in answering my question and you gave me many
different ideas to pursue. Thank you for your fine work.

Stopyerwhining

Hi stop,

   Thank you for the stars and tip! Both are appreciated, and I'm glad
to have helped!

Sincerely, Crabcakes