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Pipex Pharmaceuticals Announces Notice of Allowance of U.S. Patent for Oral TTM for Alzheimer’s Disease
Wednesday, May 07, 2008
Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and autoimmune diseases, announced today that it has received a notice of allowance from the United States Patent and Trademark Office for exclusively licensed U.S. patent application Ser. No. 11/057.353 containing claims covering the use of thiomolybdates such as oral tetrathiomolybdate (oral TTM) for the treatment of Alzheimer's disease (AD).
Pipex's anti-copper product candidate oral TTM, a thiomolybdate covered by this notice of allowance, has demonstrated a 40% reduction in insoluble amyloid-beta (p < 0.05), a key Alzheimer's disease protein in preclinical animal models of AD. Oral TTM's specificity and unique mechanism of action for rapidly lowering toxic free copper levels, may position oral TTM as the first available therapeutic agent capable of correcting the serum and CNS free copper dyshomeostasis that might represent an important fundamental cause of AD. Oral TTM's ability to specifically bind and reduce free copper levels differentiates it from other non-copper chelating agents that liberate bound copper stores thereby increasing free copper levels and CNS exposure to free copper.
"As the growing body of scientific evidence continues to implicate toxic free copper exposure from residential tap water and free copper-containing multivitamins marketed to the elderly, we believe that there will be a place for compensatory CNS decoppering agents such as oral TTM. This notice of allowance supplements our exclusively licensed oral TTM intellectual property which includes U.S. Patent No. 6,855,340. We anticipate that this important notice of allowance for the first free copper specific CNS anti-copper agent will be followed by further allowances from our leading patent estate covering the use of anti-copper strategies for the millions of existing AD patients suffering from accumulated neurodegenerative copper-containing CNS plaques and tangles," said Steve H. Kanzer, Chairman and CEO of Pipex.
Market Opportunity for Oral TTM in Alzheimer's Disease
It is estimated that more than 4.5 million Americans and 12 million people worldwide suffer from AD. Risk factors for the disease include age and family history. Age is the most important risk factor for AD; the number of people with the disease doubles every five years beyond age 65. According to the Alzheimer's Association, the disease affects one in 10 persons over the age of 65, and 50% of those over 85 years old.
There is an urgent need for an effective treatment for the illness, caused in part by the rising health care, institutional, and social costs for the treatment and care of Alzheimer's sufferers. In May 2002, the National Institute on Aging (NIA) reported that the cost of care to family, caregivers and society in general was estimated to exceed $100 billion per year, up from $18 billion in 1996, ranking AD as the disease with the greatest economic cost to society. These costs are expected to rise sharply as the baby-boom generation ages and more people become at risk for the disease. As people live longer, their risk of developing AD increases.
The market for treatment of AD is equally large, accounting for $3 billion in worldwide sales in 2004. This market is expected to grow to $5 billion by 2009. Aricept®, an FDA-approved acetylcholinesterase inhibitor, is the top-selling treatment, accounting for 40% of the Alzheimer's-drug market in 2004 with $1.35 billion in sales and year-over-year revenues growing by 17% per annum.
About Oral TTM
Oral TTM is a 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 oral TTM 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), NFkB, TGF-B, FGF-2, IL-1, IL-6, IL-8, and connective tissue growth factor (CTGF).
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. ("Pipex") is a specialty pharmaceutical company that is developing four proprietary, late-stage drug candidates for the treatment of neurologic and autoimmune diseases. Pipex's strategy is to exclusively in-license proprietary, clinical-stage drug candidates and develop them for the treatment of Dry Age-Related Macular Degeneration (AMD), Multiple Sclerosis (MS), Fibromyalgia, Alzheimer's disease and Huntington's disease. For further information, please visit www.pipexinc.com.
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Pipex's plans for its product candidates. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Pipex is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Pipex's forward-looking statements include, among others, a failure of Pipex's product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, a lack of acceptance of Pipex's product candidates in the marketplace, a failure of the company to become or remain profitable, Pipex's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors described in Pipex's report on Form 10-K for the year ended December 31, 2007. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Pipex undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
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