US Patent Office Issues Patent for Novel Composition of DFMO and Chitosan.

Seattle, WA June 10, 2004 -- The US patent office has issued patent number 6,630,511, entitled "Water-soluble salts of 2-difluoromethyl-2,5-diaminopentanoic acid (DFMO)" to Rolland Hebert of Seattle. The patent, issued on Oct 7, 2003, discloses novel compositions of matter comprising DFMO and chitosan. The FDA approved DFMO, also known as Eflornithine, for the treatment of hirsutism (excessive facial hair) in women. DFMO, an ornithine decarboxylase inhibitor, is currently also being studied in late stage clinical trials for the prevention of breast, colon and skin cancer.

DFMO is an irreversible inhibitor of ornithine decarboxylase (ODC) that is responsible for the conversion of L-ornithine to putrescine, which in turn is converted to longer chain polyamines such as spermidine and spermine required for cellular proliferation. By inhibiting ODC, DFMO suppresses polyamine formation and consequently cellular proliferation. Since DFMO is able to suppress polyamine formation, it may able to suppress cellular proliferation and ultimately to ameliorate or prevent cancer.

Ornithine decarboxylase is also important in the human hair growth cycle and by altering ODC activity, the rate and character of hair growth may be influenced. The first topical clinical indication for the use of DFMO has been for the treatment of hirsutism in women. However, a more general application may be the use of DFMO to decrease the growth of unwanted hair in men or may even eventually be used as a substitute for the razor to control facial hair.

The new DFMO chitosan compositions may reduce the irritation associated with the topical application of DFMO, an especially important improvement over the current DFMO product on the market known as Vaniqa. Vaniqa is the first and only prescription cream proven to slow the growth of unwanted facial hair (hirsutism) in women. However, the new DFMO chitosan composition offers a potential alternative to the DFMO formulation known as Vaniqa without the burning and irritation associated with Vaniqa. The FDA requires phase III clinical studies to demonstrate efficacy in order for the new chitosan DFMO composition to be approved.

Inquiries regarding co-development of DFMO with chitosan for use either to inhibit hair growth or as a cancer chemopreventive agent are welcomed.

Contact person:
Rolland Hebert
427 Bellevue Ave E. Suite 301
Seattle, WA 98102
Telephone: 206.650.4489









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