SOURCE: Pipex Pharmaceuticals, Inc.

March 10, 2008 10:06 ET

CORRECTION: Pipex Pharmaceuticals' Oral Flupirtine IND With FDA for Phase II Clinical Trial for Fibromyalgia Not Yet Open

ANN ARBOR, MI--(Marketwire - March 10, 2008) - This press release amends and replaces the press release titled, "Pipex Pharmaceuticals' Oral Flupirtine Opens IND With FDA for Phase II Clinical Trial for Fibromyalgia," of the same date announcing the opening of an investigational new drug application (IND) for Pipex's oral flupirtine. This morning, the company has learned from the principal investigator that late Friday, the principal investigator received communication from the FDA that the IND was still on clinical hold due to outstanding chemicals manufacturing and controls issues.

About Pipex Pharmaceuticals, Inc.

Pipex Pharmaceuticals, Inc. ("Pipex") (AMEX: PP) 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 US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit www.pipexinc.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.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the IND filing for flupirtine with the FDA, as well as initiating a phase II clinical trial for flupirtine. 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 including the risks set forth in our Form 10-KSB and other filings with the Securities and Exchange Commission. We cannot assure you that we will be able to successfully develop or commercialize products based on our technologies, including COPREXA, TRIMESTA, zinc-monocysteine, EFFIRMA (oral flupirtine), SOLOVAX, 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.

Contact Information

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

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