Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical
company developing innovative late-stage drug candidates for the
treatment of autoimmune and central nervous system diseases,
announced today that its scientific collaborator has presented new
findings from a phase IIa clinical trial results using estriol for
the treatment of multiple sclerosis at the World Congress on
Treatment and Research in Multiple Sclerosis Meeting (ACTRIMS,
ECTRIMS and LACTRIMS) in Montreal, Canada. Estriol is the active
ingredient in TRIMESTA.
In a presentation from the laboratory of Dr. Rhonda Voskuhl,
Professor of Neurology at UCLA, new findings were shown which
demonstrated that estriol treatment decreases matrix
metalloproteinase (MMP). MMP plays a crucial role in the migration
of inflammatory cells into the CNS. Elevated levels of MMP-9 have
been described in serum and CSF of multiple sclerosis patients, and
they predict the occurrence of new active lesions on brain MRIs.
This was demonstrated in both MS subjects treated with estriol in a
pilot phase IIa clinical trial as well as in animals with
experimental autoimmune encephalomyelitis (EAE), the MS animal
model. The decrease in MMP-9 correlated with a decrease in
enhancing lesions by MRI in MS, and with a decrease in inflammatory
lesions by pathology in EAE, respectively. Selective estrogen
receptor agonists were then used in the MS model to show that the
mechanism through which estriol decreased MMP was through estrogen
receptor (ER) alpha. In conclusion, estriol acting via ER alpha to
reduce MMP-9 from immune cells is one mechanism potentially
underlying the estriol-mediated reduction in enhancing lesions in
MS and inflammatory lesions in EAE.
Dr. Voskuhl's group have previously reported TRIMESTA's effect
on immune modulation, MRI and cognitive testing from this clinical
study (1)(2).
TRIMESTA is the subject of an ongoing multi-center,
double-blind, placebo-controlled 150-patient phase IIb clinical
trial for the treatment of relapsing remitting multiple sclerosis
(MS) which is being funded by a $5 million grant from the National
Multiple Sclerosis Society (NMSS) in partnership with the National
MS Society's Southern California chapter, with support from the
National Institutes of Health (NIH). For further information on
this clinical trial, please visit www.clinicaltrial.gov.
About TRIMESTA
TRIMESTA is an orally active, immunomodulatory and
anti-inflammatory molecule which has been approved and marketed
throughout Europe and Asia for approximately 40 years for the
treatment of post-menopausal hot flashes, but which has never been
introduced in North America. Estriol, the active ingredient in
TRIMESTA, is a weak estrogenic-based molecule that is produced in
the placenta by women during pregnancy. Estriol is considered to
play an important role in the immunologic privilege offered to the
fetus during pregnancy, and is also thought to be responsible for
the spontaneous remission of Th1-mediated autoimmune diseases of
women (such as multiple sclerosis, psoriasis and rheumatoid
arthritis) during pregnancy, especially during the third trimester.
Pipex has an exclusive worldwide license with UCLA (through the
Regents of the University of California) to the intellectual
property rights surrounding TRIMESTA for which Dr. Voskuhl is an
inventor.
Pregnancy and MS
Doctors have known for decades that women often experience a
sharp drop in MS disease symptoms during the course of pregnancy,
specifically in the third trimester when the levels of estriol is
being produced at their highest level by the placenta. The list of
autoimmune diseases that improve during pregnancy includes multiple
sclerosis, rheumatoid arthritis, thyroiditis, uveitis, juvenile
rheumatoid arthirits, ankylosing spondylitis with peripheral
arthritis and psoriatic arthritis.
A landmark clinical study published in the New England Journal
of Medicine, known as the PRIMS study (Pregnancy in Multiple
Sclerosis) followed 254 women with MS during 269 pregnancies and
for up to one year after delivery. The PRIMS study demonstrated
that relapse rates were significantly reduced by 71 percent (p <
0.001) through the third trimester of pregnancy from pre-baseline
levels and relapse rates then increased by 120 percent (p <
0.001) during the first three months postpartum before returning to
pre-pregnancy rates (3).
About Multiple Sclerosis (MS)
MS is a chronic, usually progressive disease of the central
nervous system in which the immune system attacks and destroys the
structure, and therefore degrades the function, of nerve cells.
Approximately 400,000 Americans have MS, and virtually every hour
someone is newly diagnosed. Most are between the ages of 20 and 50,
and women are affected two to three times more often than men.
Worldwide, MS may affect 2.5 million individuals.
According to the National MS Society, the economic cost of care
for MS patients in the United States including medical and
non-medical care, production losses, and informal care exceeds $23
billion annually, or more than $57,000 per US patient per year.
Complications from MS may make it harder for people to work and may
interfere with their ability to perform common, daily activities.
During 2006, combined sales estimates of FDA-approved injectable MS
therapies, which include Avonex�, Betaseron�, Copaxone�, and
Rebif�, totaled approximately $5 billion.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. 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
proprietary, clinical-stage drug candidates and to complete the
further clinical testing, manufacturing and regulatory requirements
and seek marketing authorizations. Pipex is focused on treating
rheumatoid arthritis, dry age-related macular degeneration (AMD),
multiple sclerosis (MS), and fibromyalgia. For further information,
please visit www.pipexinc.com.
(1) Sicotte NL, Liva SM, Klutch R, Pfeiffer P, Bouvier S, Odesa
S, Wu TC, Voskuhl RR. Treatment of multiple sclerosis with
pregnancy hormone estriol. Ann Neurol. 2002 Oct. 52(4):421-8.
(2) Soldan SS, Alvarez Retuerto AI, Sicotte NL, Voskuhl RR.
Immune modulation in multiple sclerosis patients treated with
pregnancy hormone estriol. J Immunol. 2003 Dec
1:171(11):6267-74.
(3) Confavreux, C., Hutchinson, M., Hours, M.M.,
Cortinovis-Tourniaire, P., and Moreau, T. Rate of pregnancy-related
relapse in multiple sclerosis. 1998. Pregnancy in Multiple
Sclerosis Group. N Engl J Med 339:285-291.
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 commercialization
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-Q for the quarter ended June 30, 2008. 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: Nicholas Stergis Chief
Executive Officer (734) 332-7800 Thomas Redington Investor
Relations Redington, Inc. 203-222-7399 www.redingtoninc.com
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