Pipex Pharmaceuticals Announces Notice of Allowance of U.S. Patent for Oral TTM for Alzheimer's Disease
May 07 2008 - 9:00AM
Marketwired
ANN ARBOR, MI , 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.
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
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