ANN ARBOR, MI , a specialty pharmaceutical company developing
innovative late-stage drug candidates for the treatment of
neurologic and fibrotic diseases, announced today that it has
received a notice of allowance from the US Patent Office for claims
to a patent which covers the use of estrogens in combination with
other FDA-approved multiple sclerosis therapies for the treatment
of autoimmune diseases.
Pipex's product candidate TRIMESTA (oral, once-daily estriol),
which is covered by this notice of allowance, is currently in a
Phase III multi-center, placebo-controlled clinical trial in
combination with Copaxone for treatment of multiple sclerosis that
is being funded by a $5 million grant from the National Multiple
Sclerosis Society, its largest single grant ever for a clinical
trial.
Once issued, this US Patent No. 10/275,833 entitled "Method of
treating immune pathologies with low-dose estrogen" will cover the
use of estrogens and their derivatives at serum concentrations
above basal and below pregnancy levels in combination with various
immunotherapeutic agents, such as Avonex�, Betaseron�, Copaxone�,
Rebif�, and Enbrel�, for the treatment of Th1-mediated autoimmune
diseases including multiple sclerosis (MS), psoriasis, and
rheumatoid arthritis (RA). The corresponding US and Japanese
patents are currently pending.
Estriol, the active ingredient of TRIMESTA, a low potency
bioidentical estrogen used by millions of women in Europe and Asia
for over 30 years has been shown in large case controlled studies
conducted in Europe to have a substantially reduced risk of breast
cancer compared to the limited FDA-approved estrogens available to
American women. On January 9th of this year, in response to a
citizen's petition filed by Wyeth, a large pharmaceutical company
that markets potent horse derived estrogens, the FDA took action to
limit the availability of low potency estrogens as a treatment
option available to American women.
"This notice of allowance supplements our intellectual property
estate which already includes US Patent No. 6,936,599 covering the
use of TRIMESTA (oral, once daily estriol) at pregnancy levels for
the treatment of multiple sclerosis as well as our European patent
which issued last year. It will be an important addition to our
leadership position in the use of bioidentical estrogens for
women's health. We hope that the notice of allowance from this
important patent estate will be followed by further allowances
covering uses of estriol at physiologic levels to treat autoimmune
diseases of women," said Steve H. Kanzer, Pipex's chairman and
CEO.
Through a wholly owned subsidiary, Pipex has obtained exclusive
licenses to these patents from the University of California, Los
Angeles (UCLA) and Oregon Health & Sciences University
(OHSU).
About Oral TRIMESTA
TRIMESTA (oral estriol) is an orally active immunomodulatory and
anti-inflammatory molecule that has been approved and marketed
throughout Europe and Asia for the past 30 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 by women in the
placenta during pregnancy. Estriol is considered to play an
important role in the immunologic privilege offered to the fetus
during pregnancy, and it is also thought to be responsible for the
spontaneous remission of Th1-mediated autoimmune diseases, such as
multiple sclerosis and psoriasis, in women during pregnancy,
especially during the third trimester. TRIMESTA has completed a
22-month crossover Phase II clinical trial for the treatment of MS
and recently entered a Phase II/III clinical trial under a $5
million grant from the National MS Society.
About the Phase II/III Clinical Trial
The clinical study is a double-blind placebo-controlled trial
that is currently taking place at six sites in the US, enrolling up
to 150 female MS subjects. Investigators are administering TRIMESTA
to women between the ages of 18-50 who have been recently diagnosed
with relapsing-remitting MS. TRIMESTA is given in combination with
subcutaneously injected Copaxone�, a standard of care treatment for
MS. The team is evaluating effects of the treatment combination on
relapse rates by using several clinical and magnetic resonance
imaging measures of disability progression.
The current study sites include the University of California,
Los Angeles (UCLA), Ohio State University (OSU), Rutgers University
(UMDNJ), Washington University, St. Louis, University of Chicago,
and University of Utah. For further information on this Phase
II/III clinical trial, please visit www.clinicaltrials.gov.
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 with the disease. 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 $5.0 billion.
For most people with MS, the disease slowly progresses with a
series of unpredictable flare-ups, also called relapses or
exacerbations. But for some, the progression of the disease is
rapid. Relapses often lead to increasing disabilities such as
walking impairment, muscle weakness or speech or vision
impairments.
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 neurologic and fibrotic
diseases. Pipex's strategy is to exclusively in-license
proprietary, clinical-stage drug candidates and complete the
further clinical testing, manufacturing and regulatory requirements
sufficient to seek marketing authorizations via the filing of New
Drug Applications (NDAs) with the FDA in the US and Marketing
Application Authorizations (MAAs) with the European Medicines
Evaluation Agency (EMEA). For further information, please visit
www.pipexpharma.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. and subsidiaries ("we" or
"our") current expectations about its future results, performance,
prospects and opportunities, including statements regarding the our
intellectual property for TRIMESTA and potential use of COPREXA as
well as the resolution of any of the deficiencies raised by the FDA
in our New Drug Application (NDA) filing for the treatment of
initially presenting neurologic Wilson's disease, including the
potential delay in potential approval as well as the cost and
expense of conducting any additional testing, development and/or
clinical trials required by the FDA, the prospects for any
regulatory filings in the treatment of neurologic Wilson's disease,
including and/or that the FDA will agree with our analysis of data
supporting the safety, clinical efficacy, manufacturing, stability
and other regulatory requirements necessary for COPREXA to be
approved for use in neurologically presenting Wilson's disease or
that even if approved for initial indication, that we will be able
to conduct and complete necessary initial and registration clinical
trials required to support and receive FDA approval for a
Supplemental New Drug Application to market COPREXA for the
treatment of other disease indications, such as, idiopathic
pulmonary fibrosis, Alzheimer's disease and Huntington's disease,
for example. 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 risks set forth in our 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 COPREXA(TM), TRIMESTA(TM),
zincmonocysteine, SOLOVAX(TM), EFFIRMA(TM) or Anti-CD4 802-2,
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, other than as required by law. Avonex�,
Betaseron�, Copaxone�, Rebif� and Enbrel� are registered trademarks
of Biogen-Idec, Teva, Serono and Wyeth/Amgen.
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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