SOURCE: Pipex Pharmaceuticals, Inc.

January 09, 2007 10:03 ET

Pipex Pharmaceuticals' Oral COPREXA™ Demonstrates Benefit in Preventing Doxorubicin-Induced Cardiotoxicity

Results Published in the Journal Translational Research

ANN ARBOR, MI -- (MARKET WIRE) -- January 9, 2007 -- Pipex Pharmaceuticals, Inc. (OTCBB: PPXP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced the publication of preclinical results of its lead drug candidate, COPREXA™ (oral tetrathiomolybdate), in the protection against doxorubicin-induced cardiotoxicity as compared to existing FDA approved anti-copper therapies, such as zinc acetate. These results have been published in the journal Translation Research, 2006 Dec; Vol 148 (6);309-14.

In these published preclinical experiments sponsored by Pipex, COPREXA™ protected against doxorubicin-induced cardiotoxicities and its efficacy was compared to other orally available agents. Doxorubicin is one of the most effective and widely used chemotherapeutic agents used to treat a variety of cancers. Its use, however, is ultimately limited by its cumulative cardiotoxic effects which can cause delayed onset congestive heart failure in patients. In these published experiments, standard measurements of heart damage were measured for COPREXA™ in comparison to the active ingredient in the oral anti-copper therapy zinc acetate. Specifically, COPREXA-treated animals demonstrated statistically significant inhibition of troponin I (p < 0.003), lactic dehydrogenase (LDH) (p=0.006) and creatine kinase MB (CK-MB) (p < 0.04) levels, all three standard measurements of cardiac toxicity. Zinc therapy had relatively less and generally insignificant effects on all three measurements.

Dr. George J. Brewer, Emeritus Professor of Human Genetics at the University of Michigan, inventor of COPREXA™ and the article's lead author commented, "These results are consistent with our previous findings that the inhibition of various key inflammatory pathways, such as the TGF-beta and IL-1beta pathways by COPREXA™ has broad applicability across numerous autoimmune, inflammatory and fibrotic diseases, including protection from cardiac induced toxicities. Reducing toxicities of existing therapies, such as to anthracyclines is an important treatment modality for the seven million people who die each year from cancer. Reducing doxorubicin toxicity might enable patients to endure increased doses of chemotherapeutic agents while maintaining quality of life. It is clear that the mechanism of copper binding and inhibition of copper catalyzed events with COPREXA™ is superior to other anti-copper therapies, such as zinc, which simply lowers copper in the body."

Conventional anthracyclines such as doxorubicin are among the most widely used agents for the treatment of breast cancer in both the adjuvant and metastatic settings. Considered a mainstay of therapy for several decades, conventional anthracycline-containing regimens have demonstrated benefits in terms of response rate, time to disease progression, and overall survival. However, the clinical utility of these agents may be limited by their toxicity profiles, which include cumulative cardiotoxicity resulting in congestive heart failure (CHF) and death. Anthracyclines constitute a major class of cytotoxic agents for the treatment of cancer. Among these, doxorubicin possesses a broad spectrum of antitumor activity. The reduction of doxorubicin-induced cumulative cardiomyopathy represents a major goal in improving the clinical application of doxorubicin. It has been recognized at an early stage that anthracycline-induced cardiotoxicity is a problem observed in 2 to 20% of patients receiving anthracyclines.

Several mechanisms of action have been suggested for doxorubicin-induced cardiotoxicity, but the development of free radicals is still the most favored. Doxorubicin can generate oxygen radicals in several ways, either by itself or by forming a complex with iron ions. Production of radicals is generally attributable to redox cycling of doxorubicin.

Dr. Charles Bisgaier, President of Pipex, commented, "Given its convenience of oral dosing and unique mechanism of action, COPREXA™ may offer cancer patients an extended window of cardioprotection that is synergistic with the currently approved cardioprotectant agents that are required to be administered contemporaneous with doxorubicin IV thereby potentially improving patient outcomes." Dr. Bisgaier went on to say, "We intend to meet with the FDA to discuss the potential design of clinical trials necessary for approval of this important indication."

About COPREXA™

COPREXA™, is an oral, small-molecule, anti-copper agent that is highly specific for the reduction of free copper in serum, the most toxic form of copper in the body, and is thus ideally suited for the treatment of central nervous system (CNS) diseases in which abnormal serum and CNS copper homeostasis are implicated. COPREXA has completed pivotal clinical trials for the treatment of neurologic Wilson's disease for which we are planning to file a New Drug Application (NDA). We are also developing COPREXA™ for fibrotic disorders based upon the rationale that the fibrotic disease process is dependent upon the availability of free copper in the body. COPREXA™ has demonstrated the ability to inhibit fibrosis in a number of well established animal models through the sequestration of available copper and inhibition of key fibrotric cytokines, including secreted protein acid rich in cysteine (SPARC), NFkappaB, TGF-beta, FGF-2, IL-1, IL-6, IL-8, and connective tissue growth factor (CTGF).

COPREXA™ recently completed a 12-month phase II clinical trial for the treatment of refractory idiopathic pulmonary fibrosis (IPF), a fatal respiratory disease and is currently in a phase II clinical trial for the treatment of primary biliary cirrhosis (PBC), a fibrotic disease of the hepatic system.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and complete the further clinical testing, manufacturing and regulatory requirements sufficient to seek marketing authorizations via the filing of New Drug Applications (NDAs) with the FDA in the U.S. and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information, please visit, www.pipexpharma.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect Pipex Pharmaceuticals, Inc. and its subsidiary Pipex Therapeutics, Inc. ("we" or "our") current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential uses of COPREXA™, as well as its the prospects for regulatory filings in the treatment of neurologic Wilson's disease. Where possible, the Company has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA™, TRIMESTA™, SOLOVAX™, EFFIRMA™ or Anti-CD4 802-2, particularly in light of the significant uncertainty inherent in developing, manufacturing and conducting preclinical and clinical trials of new pharmaceuticals, and obtaining regulatory approvals, that our technologies will prove to be safe and effective, that our cash expenditures will not exceed projected levels, that we will be able to obtain future financing or funds when needed, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that we will be able to successfully obtain any further grants and awards, maintain our existing grants which are subject to performance, that we will be able to patent, register or protect our technology from challenge and products from competition or maintain or expand our license agreements with our current licensors, or that our business strategy will be successful. All forward-looking statements made in this press release are made as of the date hereof, and the Company assumes no obligation to update the forward-looking statements included in this news release whether as a result of new information, future events, or otherwise. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements.

Contact Information

  • For Further Information Contact:

    Steve H. Kanzer, CPA, Esq.
    Chairman and Chief Executive Officer
    (734) 332-7800

    Charles Bisgaier, Ph.D.
    President
    (734) 332-7800