I just completed fasciectomy number 8 at Mayo. Number 9 will probably be needed within 6 months. I'm interested in getting into Phase 3 clinical testing as was my Doc. He wrote a "sympathy" letter to the New York facility but I was turned down. I live in Milwaukee and would prefer Evanston/Chicago. Suggestions???

I had heard that the testing was cancelled. Originally, the injections were supposed to have been available this year (2003) but for some reason all testing seems to have been stopped. When I see my surgeon again (another post op visit) in February I'll ask her and see if she knows anything about it.

Just got an email from Dr. Roy Meals at UCLA where testing will occur and he says there is no news.

I don't know that's all he wrote in his email. A previous email (July 8 of last year) said that he thought Phase 3 testing would begin in Jan/Feb of this year.

I suggest that somebody may want to contact the company.

I originally posted the following on 11/21/02 under 'Update on Phase III Collagenase Clinical Trials'...


"There have been many inquiries in the forum regarding the progress of the Phase III Collagenase trials. According to the U.S. National Institutes of Health ClinicalTrials.gov website, the Phase III trials are still not at the point of starting recruitment after almost a year of Phase II completion and the FDA's approval to proceed.

On 11/20/02, I contacted one of the principal researchers involved with the DP clinical trials and asked about the status of the Phase III trials and also inquired about the reasons for the delay. I received the following response:


"The FDA required a complete redesign of the proposed Phase 3 protocol, that is, the way the trials are to be conducted.
The FDA also required a complete chemical characterization of the drug for Phase 3 studies.
These were intensely time consuming tasks for the investigators and took a very long time to do.
The FDA has also taken a very long time to review these submissions.
The FDA has recently been in touch with us about additional protocol changes and pending our submission of
those, we hope to start Phase 3 trials in the winter of 2003.

RECRUITMENT IS CLOSED AND PATIENT ENROLLMENT IS CLOSED AT ALL FOUR TEST CENTERS. (However, this statement may no longer be accurate at the time of this 1/16 posting.)

Please DO NOT lobby the FDA. It would be counterproductive. The only way for the FDA to approve this treatment
is to allow us to do well controlled, scientifically accurate trials which will stand the test of FDA review."


Personally, I cannot see how lobbying the FDA could negatively impact the progress of the trials. There are many DP afflicted people who are trying to make long-term treatment decisions based on the FDA's responsiveness and cooperation in approving the collagenase therapy. I was advised that if any patients in the forum are requiring surgery (or other form of treatment), you should have it and not wait for FDA approval in that approval may still be years away."


Following my original 11/21 posting, I received a few apathetic (and not so humorous) comments regarding lobbying the FDA and their likely disregard for what some believe is a low profile ailment on the FDA's radar screen. Even if lobbying the FDA is a waste of time (and I don't think it would be), doing nothing rather than something is a weak attitude. I'm doing my part and not 'warming the bench'.

Mike