Pipex Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, has received a broadly issued European patent which covers the use of estrogens in combination with other FDA-approved multiple sclerosis therapies for the treatment of autoimmune diseases.
The issued European patent, EP1286664 entitled, "Combination of Low Dose Estrogen and Immunotherapeutic Agent for Treating Immune Diseases," covers the use of estrogens and their derivatives at serum concentrations above basal and below pregnancy levels in combination with various immunotherapeutic agents, such as, Avonex, Betaseron, Copaxone, Rebif and Enbrel for the treatment of Th1-mediated autoimmune diseases, such as, multiple sclerosis (MS), psoriasis and rheumatoid arthritis (RA). The corresponding US and Japanese patents are currently pending.
"This patent issuance supplements our intellectual property estate which already includes US Patent No. 6,936,599 which covers the use of Trimesta at pregnancy levels for the treatment of multiple sclerosis. This issued patent is an important addition to our leadership position in estrogen therapy for the treatment of autoimmune disease in women" said Steve H. Kanzer, Pipex's chairman and CEO.
Through a wholly-owned subsidiary, Pipex has obtained exclusive licenses to these patents from the University of California, Los Angeles (UCLA) and Oregon Health & Sciences University (OHSU).
Trimesta (oral estriol) is an orally active immunomodulatory and anti-inflammatory molecule that has been approved and marketed throughout Europe and Asia for the treatment of post-menopausal hot flashes for approximately 30 years, but has never been introduced in North America. Estriol, the active ingredient in Trimesta, is a weak estrogenic-based molecule that is produced in the placenta by women during pregnancy. Estriol is considered to play an important role in the immunologic privilege offered to the fetus during pregnancy and is also thought to be responsible for the spontaneous remission of Th1-mediated autoimmune diseases of women (such as multiple sclerosis and psoriasis) during pregnancy, especially during the third trimester. Trimesta has completed a 22-month crossover phase II clinical trial for the treatment of MS and has recently entered a phase II/III clinical trial under a $5 million grant from the National MS Society.