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orphan drug status for bovine collagen treatment for SSc

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Did anyone else see the news item on orphan drug status being given to a drug that is being developed from bovine collagen to treat SSc? It's supposed to be in Ph. 2 trials at the University of Tenn. and other places. Apparently it will be administered orally and is supposed to desensitize the autoimmune system and its response to Type 1 Collagen. Any thoughts?

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Thanks for bringing this up. We did run the media article back in February. If you didn't see it, here's the link:


arGentis Receives Orphan Drug Designation. The FDA has granted orphan drug designation to arGentis' product ARG201(native type 1bovine collagen) for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma (SSc). SSc is a debilitating and fatal autoimmune disease. BusinessWire. 02/08/08.


Here's the outcome of the 168 patient study:

Data from the trial demonstrated a statistically and clinically significant improvement in Modified Rodnan Skin Scores (MRSS), a measure of the change in skin thickening and an FDA-mandated endpoint, at 15 months in late phase patients receiving the treatment versus the placebo group (p=0.006). CI was also shown to be safe and well-tolerated.


My thoughts - I'm thrilled that they are continuing to look for a cure. This certainly didn't prove to be a cure, but it seemed to have helped with skin thickening. It would be interesting to know if it helped with fibrosis of the internal organs. I do like that fact that it's not a chemical concoction.


Big Hugs,

Janey Willis

ISN Support Specialist

(Retired) ISN Assistant Webmaster

(Retired) ISN News Director

(Retired) ISN Technical Writer for Training Manuals

International Scleroderma Network (ISN)

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read something about it a week ago,I rushed through it- sounds promising. Do you have the link again, it's just that I'm ina chemo fog. :) TJ

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