ANN ARBOR, Mich., Oct. 7, 2008 (GLOBE NEWSWIRE) -- Pipex Pharmaceuticals, Inc. (AMEX:PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of central nervous system and autoimmune diseases, today announced that its double-blind, randomized, placebo-controlled phase II clinical trial of oral flupirtine for the treatment of fibromyalgia has received ethics committee approval to initiate the clinical trial.
Fibromyalgia is a rheumatic pain disease which affects an estimated six million Americans with only one FDA-approved therapy, Lyrica(r). During its second full year of in-market sales, Lyrica(r) recorded $1.8 billion in sales during 2007, with 47-percent annual growth.
Oral flupirtine has been approved as a treatment of pain in Europe since 1984 but has never been approval for any indication in the U.S. Flupirtine, a non-opiate analgesic, has been used in Europe for post-surgical pain, cancer pain, trauma pain, pain associated with liver disease, and other nocioceptive pain states. According to post-marketing surveillance, flupirtine has been given to more than 1.5 million patients and 2,776 patients have been studied in various controlled clinical trials with flupirtine.
Dr. Andrew L. Stoll, director of the Psychopharmacology Research Laboratory at McLean Hospital, a Harvard University-affiliated teaching hospital and inventor of this new use for the drug, commented, "The Institutional Review Board (the Committee charged with oversight of all human subjects research at McLean) has approved the initiation of a formal phase II clinical study using flupirtine as a therapeutic agent in treatment-refractory fibromyalgia patients. Due to its rapid onset of action and high response rate, 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."
Nicholas Stergis, Pipex's chief executive officer, stated, "We are pleased to have received this approval to initiate the double-blind, placebo-controlled phase II clinical trial with oral flupirtine for the treatment of fibromyalgia, a pain disorder seen by rheumatologists. This program complements our rheumatic disease franchise, which includes our lead molecule, oral dnaJP1 for the treatment of rheumatoid arthritis (RA) which has completed a 160 patient, double-blind, placebo-controlled phase II clinical trial. Later this month, at the American College of Rheumatology (ACR) meeting, we intend to release additional data regarding oral dnaJP1."
Phase II Clinical Trial of Oral Flupirtine in Fibromyalgia
This phase II clinical trial is designed as a double-blind, placebo-controlled phase II 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; 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 improvement in overall level of functioning. During April 2008, oral flupirtine received an IND from the FDA to initiate this clinical trial.
Preclinical data and clinical experience suggests that flupirtine should also be effective for treating neuropathic pain since it acts in the central nervous system. Flupirtine is especially attractive as a treatment for neuropathic pain 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.
Pipex has 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.
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 central nervous system and autoimmune diseases. Pipex's strategy is to exclusively in-license clinical-stage drug candidates for the treatment of unmet medical diseases. Pipex is focused on developing products to treat rheumatoid arthritis, dry age-related macular degeneration (AMD), multiple sclerosis, and fibromyalgia. 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 ethics committee approval for oral flupirtine, initiating a phase II clinical trial for flupirtine, as well as clinical data in glaucoma, retinitis pigmentosa, diabetes retinopathy and Dr. Stoll's belief that flupirtine may represent a new therapeutic modality for the treatment of fibromyalgia. 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-Q 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, dnaJP1, TRIMESTA, Zinthionein, oral flupirtine, SOLOVAX, oral TTM, or CD4 inhibitors, 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.
Lyrica(r) is a registered trademark of Pfizer, Inc.