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PP Meet Kevin Pricing Power ETF

28.90
0.5182 (1.83%)
After Hours
Last Updated: 21:27:59
Delayed by 15 minutes
Name Symbol Market Type
Meet Kevin Pricing Power ETF AMEX:PP AMEX Exchange Traded Fund
  Price Change % Change Price High Price Low Price Open Price Traded Last Trade
  0.5182 1.83% 28.90 28.745 28.42 28.42 5,227 21:27:59

Pipex Pharmaceuticals' Oral TRIMESTA Phase IIa Clinical and Preclinical Findings Presented at World Congress on Treatment and Re

19/09/2008 1:30pm

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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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