Pipex Pharmaceuticals' Oral Flupirtine Opens IND With FDA For Phase II Clinical Trial For Fibromyalgia

Main Category: Fibromyalgia
Also Included In: Body Aches;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 11 Mar 2008 - 2:00 PDT

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Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, today announced that the United States FDA has accepted a Pipex-supported, investigator-initiated, Investigational New Drug Application (IND) to conduct a double-blind, randomized, placebo-controlled Phase II clinical trial of oral flupirtine for the treatment of fibromyalgia, a rheumatic pain disease. Fibromyalgia affects an estimated 6 million people in the U.S. and recently Pfizer's Lyrica® became the first FDA-approved treatment for fibromyalgia. The market for fibromyalgia treatments is expected to grow to several billion dollars annually in the coming years.

Oral flupirtine has been approved as a treatment of pain in Europe since 1981 but has never been approval for any indication in the U.S. Flupirtine, a non-opiate analgesic, has been used in Europe for more than 25 years for post-surgical pain, cancer pain, trauma pain, pain associated with liver disease, and other nocioceptive pain states. Preclinical data and clinical experience suggests that flupirtine should also be effective for neuropathic pain since it acts in the central nervous system. Flupirtine is especially attractive because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception, and flupirtine may be the NMDA (N-methyl-D-aspartate) glutamate system, a major receptor subtype for the excitotoxic neurotransmitter, glutamate. Flupirtine has strong inhibitory actions on NMDA-mediated neurotransmission.

Dr. Andrew L. Stoll, director of the Psychopharmacology Research Laboratory at McLean Hospital, a Harvard University-affiliated teaching hospital and inventor of this program, commented, "Due to its rapid onset of action and high response rate in treatment-refractory fibromyalgia patients, I believe flupirtine may represent a new therapeutic modality for the treatment of this debilitating disease which affects more than six million Americans. There is a strong scientific rationale supporting the development of flupirtine for the treatment of fibromyalgia."

"For example, other NMDA receptor antagonists, such as ketamine, have also demonstrated efficacy in fibromyalgia, but have an unacceptable side-effect profile, "Dr. Stoll continued. "Based on the extensive database of prior human experience with flupirtine for general pain conditions, coupled with my own experience in treating refractory fibromyalgia patients on an individual patient basis, I believe flupirtine may be an exciting and highly promising treatment option to this devastating disease."

Steve H. Kanzer, Pipex's Chairman and Chief Executive Officer, stated, "Oral flupirtine has been marketed for more than two decades in Europe for the treatment of pain-related diseases. As we enter this Phase II clinical trial of oral flupirtine for treatment of fibromyalgia, the product's substantial human experience coupled with the promising human data already generated in refractory fibromyalgia patients, represents an exciting new approach to treating this widespread often debilitating disease."

Mr. Kanzer went on to say, "The rapid onset of action and mechanism of action may make oral flupirtine an attractive treatment option in the rapidly growing projected multibillion dollar fibromyalgia market."

During November 2005, Pipex entered into an exclusive worldwide license to issued U.S. patent 6,610,324 and pending international patents from McLean Hospital, a Harvard University-affiliated teaching hospital relating to flupirtine's use to treat fibromyalgia syndrome.

Phase II Clinical Trial of Oral Flupirtine in Fibromyalgia

This phase II clinical trial is designed as a double-blind, placebo controlled phase II clinical trial which would evaluate safety and efficacy of oral flupirtine vs. placebo in fibromyalgia patients. This phase II clinical trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days and the primary endpoint will be a reduction in musculoskeletal pain and the overall symptoms of fibromyalgia. Secondary outcomes of the study will be a reduction in the severity of mood, fatigue, cognitive symptoms, and sleep disturbance, as well as improve the overall level of functioning.

About Fibromyalgia

Fibromyalgia is an arthritis-related condition that is characterized by generalized muscular pain and fatigue. It is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. It is estimated to affect between two and four percent of the world's population and after, osteoarthritis, is the most commonly diagnosed disorder in rheumatology clinics.

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 US and Marketing Application Authorizations (MAAs) with the European Medicines Evaluation Agency (EMEA). For further information please visit http://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.

Pipex Pharmaceuticals

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