Axcentua’s lead clinical candidate, AXP-107-11, or genistein sodium salt dihydrate (genistein-SSDH) is a crystalline sodium salt of genistein with two water molecules, a “crystalline genistein sodium salt dihydrate.” Axcentua’s US Patent 7,863,325, which will expire in December 2029, covers AXP-107-11 as a composition of matter, therapeutic compositions containing AXP-107-11, and numerous methods of treatment using AXP-107-11. In addition to AXP-107-11, Axcentua has identified eight additional crystalline salts and one additional crystalline hydrate of genistein. This is a total of ten crystalline forms of genistein. Axcentua has patents applications pending in eleven countries for the ten crystalline forms of genistein. A patent on all ten crystalline forms of genistein was recently issued in South Africa (South African Patent No. 2011/05045) “Crystalline forms of genistein, compositions comprising the same and uses thereof” with a patent term of 20 years from the filing date of December 11, 2009.
In addition, Axcentua has filed a provisional application directed to a complementary technology generally applicable to poorly water-soluble drugs, including genistein. This technology is not limited to one drug as the crystalline form patents are directed to only genistein compositions. There seems to be potential with this invention for the development of a platform for poorly soluble APIs.