SOURCE: Pipex Pharmaceuticals, Inc.

April 30, 2007 09:00 ET

Pipex Pharmaceuticals Provides Update on COPREXA at Annual Wilson's Disease Association Conference

Results of New Investigational Diagnostic Device Capable of Rapid and Direct Free Copper Measurement Also Presented

ANN ARBOR, MI -- (MARKET WIRE) -- April 30, 2007 -- Pipex Pharmaceuticals, Inc. (OTCBB: PPEX) ("Pipex"), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it presented two oral presentations at the Annual Wilson's Disease Association (WDA) Conference in New York on April 28th. The presentations entitled "Tetrathiomolybdate for Neurological Initial Presenting Wilson's Disease - an Industry Drug Development Perspective" and "Direct Measurement of Free and Bound Copper with a New Electrochemical Device - FreeBound" were presented by Steve H. Kanzer, Chairman and Chief Executive Officer of Pipex.

Mr. Kanzer provided an update on the pivotal clinical trials conducted using COPREXA (oral tetrathiomolybdate) for the treatment of neurologic Wilson's disease and reiterated the company's goal of filing a New Drug Application (NDA) in October of this year. Mr. Kanzer also introduced and presented results of a new diagnostic device (FreeBound) developed by Pipex that for the first time can directly measure free copper levels in serum which Pipex believes may assist in the earlier diagnosis, screening and management of persons with Wilson's disease. Although Wilson's is an inherited disease, a genetic test has been difficult to develop due to the great number of variations in the ATP7B gene. Variations in the ATP7B gene impair the normal excretion of copper via the liver resulting in elevated serum "free copper" levels that cause neurodegeneration in the brains of affected patients.

Mr. Kanzer stated, "We are pleased to present at this important annual gathering of Wilson's disease specialists, patients and caregivers. Wilson's disease is an unmet and underdiagnosed disease which untreated causes psychiatric symptoms, permanent neurologic damage resembling Parkinson's disease and liver damage often requiring liver transplant. In my presentation to the Wilson's disease community, we discussed this new device which for the first time can directly detect levels of free copper in serum. We believe this device may facilitate the diagnosis of new Wilson's disease patients earlier and hopefully prior to their presentation or further progression of symptoms." In addition, Mr. Kanzer said, "the FreeBound device may also be useful in monitoring serum free copper levels during the management of neurologically and hepatically affected Wilson's patients."

John S. Althaus, Vice President of Advanced Technologies of Pipex and co- inventor of the FreeBound Device stated, "This device is an important tool in the advancement of Pipex's franchise in the management of copper mediated diseases."

The FreeBound Device

Copper, an essential metal, is made available to organs throughout the body via the systemic circulation via a tightly regulatory system of copper chaperones and copper transport proteins. Normally, approximately 90% or more of serum copper is tightly bound to the serum copper chaperone called ceruloplasmin (Cp). The remaining 10% of serum copper represents the so-called "free" or "non-ceruloplasmin bound" copper pool and can be highly toxic to the brain the organ which is most sensitive to the effects of free copper. In Wilson's disease patients, the free copper pool is expanded and causes psychiatric symptoms and neurodegeneration in affected patients.

Direct and accurate measurement of this important toxic pool of free copper in serum has until now remained elusive. The current standard methodology for measuring free copper relies instead on an inexact indirect estimate involving a two-step process. First, total serum copper is typically measured using an expensive and time consuming technique called atomic absorption. Second, serum Cp concentrations are determined by immunoassay or enzymatic assay. Once Cp is determined, the estimated amount of copper atoms believed to be bound to Cp is calculated and subtracted from total copper to arrive at an estimate of free copper in serum. The result is an inexact, expensive and time consuming process that carries a large potential for error based on erroneous assumptions and experimental deviations from multiple measurements.

We believe that using the FreeBound device free copper levels can be determined using technology similar to and as simple to use as a glucometer that incorporates electrochemical detection. Serum is applied to test strips attached to a meter. The meter is programmed to separate and measure free copper versus Cp-bound copper on the test strip immediately displaying the results on the meter.

Serum samples from Wilson's patients were tested for free copper using the standard indirect method and compared to results directly measured using the FreeBound device. The results are shown in the following table:

Parameter       Free Copper - Indirect  Free Copper - Direct FreeBound
                Standard Method         Device
N               16                      16
Mean            36.3 micro-g/dl         39.0 micro-g/dl
Range           0-226 micro-g/dl        3-232 micro-g/dl
Correlation
 Coefficient    0.964
Over a wide range of values, we find an impressive close correlation between free copper values determined by the indirect method compared to the direct FreeBound device method. The advantage of the direct FreeBound device method is that it is direct, inexpensive, rapid (results displayed within minutes) user friendly and may yield a much more accurate measurement of true free copper levels. Pipex intends to communicate with the FDA regarding the regulatory requirements necessary to commercialize the FreeBound device. The FreeBound device and methods are the subject of pending patents owned by Pipex.

About the Wilson's Disease Association (WDA)

The Wilson's Disease Association (WDA) is an all-volunteer organization striving to promote the well being of patients with Wilson's Disease and their families and friends. The Wilson's Disease Association funds research and facilitates and promotes the identification, education, treatment, and support of patients and other individuals affected by Wilson's Disease. For more information on the WDA, please visit www.wilsonsdisease.org.

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. 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 fibrotic 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™ has also completed a one-year open label phase II clinical trial for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a deadly lung disease and is also in a phase II clinical trial for the treatment of primary biliary cirrhosis (PBC), a fibrotic disease of the hepatic system. This phase II clinical trial is being supported by an $850,000 grant from the FDA's Orphan Drug Group.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals, Inc. and its subsidiaries ("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 Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, that reflect Pipex's current expectations about its future results, performance, prospects and opportunities, including statements regarding the further development of the FreeBound copper detection device as well as COPREXA™ as a potential treatment for neurologic Wilson's disease and the possibility of an NDA filing for this indication. Where possible, we have 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. Risks, uncertainties and factors pertaining to the advancement and further clinical development of COPREXA and the development of the new diagnostic device relating to free copper include the possibility that the new diagnostic device may not provide for earlier diagnosis and that we will not 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, obtaining regulatory approvals, and that product development and commercialization efforts may 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. For a more detailed discussion of these risks and other uncertainties, see "Risk Factors" in Pipex's Form 10-KSB filed with the SEC on April 2, 2007. All forward-looking statements made in this press release are made as of the date of this press release, and Pipex 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, except as may be required by law. FreeBound™ is a trademark of Pipex Diagnostics Inc., a subsidiary of Pipex Pharmaceuticals, Inc.

Contact Information

  • For Further Information Contact:
    Steve H. Kanzer, CPA, Esq.
    Chairman and Chief Executive Officer
    (734) 332-7800

    Redington, Inc. (Investor Relations)
    Thomas Redington
    203-222-7399
    www.redingtoninc.com