ANN ARBOR, MI, Jan 12, 2007 (MARKET WIRE via COMTEX) -- Pipex Pharmaceuticals, Inc. (PPXP : PPXP News , chart, profile, more
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PPXP, , ) , a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has completed the previously disclosed planned acquisition of its majority-owned subsidiary, Effective Pharmaceuticals, Inc. (EPI). As a result of this acquisition, Pipex has gained broader control of Effective Pharmaceuticals, Inc.'s (EPI) lead products, Anti-CD4 802-2 and CORRECTA(TM), both of which are in phase II clinical stage of development.
Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex stated, "Consummation of this transaction gives Pipex improved economics and greater control with respect to our important Anti-CD4 802-2 and CORRECTA programs."
Anti-CD4 802-2
Pipex is developing a series of rationally designed small molecule/peptidomimetic inhibitors of the highly important CD4 co-receptor of T-cells. Pipex's lead anti-CD4 molecule, Anti-CD4 802-2, is a cyclic heptapeptide that has demonstrated efficacy in a number of animal models of multiple sclerosis and other animal models of autoimmune disease and is currently nearing completion of a dose ranging phase I/II clinical trial for the prevention of graft-versus-host disease (GvHD), a life threatening transplant disease. Preliminary data from the study appears to show suppression of GvHD in treated patients. In addition, Pipex plans to broaden the therapeutic utility of these molecules through additional preclinical and clinical studies for other CD4-mediated diseases. Some of these diseases might include, induction of immune tolerance to widely marketed exogenous biologic agents, multiple sclerosis, psoriasis, transplant-related ischemic reperfusion injury, lupus, asthma and rheumatoid arthritis. Anti-CD4 802-2 may represent the first clinical stage, non-biologic molecule capable of inducing immune tolerance for a variety of CD4-mediated autoimmune diseases. Anti-CD4 802-2 has also demonstrated oral activity animal models of disease.
This Anti-CD4 program is the subject of 41 issued and pending patents including composition of matter and method of use patents, which have been exclusively licensed from Thomas Jefferson University (TJU). This program has received substantial development support in the form of grants from the National Institutes of Health, as well as a $3.5 Million grant from the Trustees of Thomas Jefferson University.
CORRECTA(TM)
Pipex is developing CORRECTA(TM), a proprietary retention enema formulation of the widely used topical antifungal agent clotrimazole, for the treatment of acute refractory pouchitis, a subset of inflammatory bowel disease related to ulcerative colitis (UC). CORRECTA(TM) is currently the subject of a double-blinded, placebo-controlled, multi-center, four-week treatment period, phase II clinical trial for acute pouchitis. This clinical trial, called the "CAPTURE" study, is currently being funded by a $750,000 grant from the FDA's Orphan Drug Group. Pipex has expanded this study to additional clinical centers in order to increase enrollment and expedite completion of the study.
About the Transaction
The acquisition was consummated when EPI merged with and into a wholly owned subsidiary of Pipex, Effective Acquisition Corp., with EPI being the surviving corporation. In the transaction, Pipex issued approximately 2.29 million unregistered shares of common stock of Pipex, warrants and options (many of which are contingent upon various developmental and regulatory milestones being achieved) to purchase 695,183 shares of Pipex common stock to the minority shareholders of EPI comprising approximately thirty-three percent (33%) of EPI that Pipex did not already own.
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