Pipex Pharmaceuticals Announces Broadly Issued European Patent Covering Uses of Oral TRIMESTA for the Treatment of Autoimmune Diseases, Including Multiple Sclerosis 06 September 2007
Claims Covering Use of Estrogens Including TRIMESTA, in Combination With Popular Immunotherapies to Treat Multiple Sclerosis.
Pipex Pharmaceuticals, Inc, a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it 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 U.S. and Japanese patents are currently pending.
"This patent issuance supplements our intellectual property estate which already includes U.S. 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).
About Oral TRIMESTA
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.
About the Phase II/III Clinical Trial
The clinical study is a double-blind, placebo-controlled trial that is currently taking place at seven sites in the U.S., enrolling up to 150 female MS subjects. Investigators are administering TRIMESTA to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. TRIMESTA is given in combination with subcutaneously injected Copaxone®, a standard of care treatment for MS. The team is evaluating effects of the treatment combination on relapse rates using several clinical and magnetic resonance imaging measures of disability progression.
The study sites include the University of California, Los Angeles (UCLA), Ohio State University (OSU), Rutgers University (UMDNJ), Washington University, St. Louis, University of Chicago, University of Utah and Wayne State University.
Source: Pipex Pharmaceuticals, Inc (06/09/07)