ANN ARBOR, MI , a specialty pharmaceutical company developing
innovative late-stage drug candidates for the treatment of
neurologic and autoimmune diseases, today announced its clinical
update and results for its first quarter of 2008.
A conference call has been scheduled for 4:30pm EDT today. In
order to participate in the conference call, please call toll free:
800-355-4959 and international dial-in: 416-695-6622. A replay of
the conference call will be archived for at least 15 days on
Pipex's website at www.pipexinc.com.
Recent achievements and accomplishments included:
-- Completion of submission, peer review and acceptance of manuscript
describing results of the Z-Monocys (oral zinc-monocysteine) 80-patient,
double-masked, placebo-controlled clinical trial in the treatment of Dry
Age Related Macular Degeneration (AMD).
-- Received FDA approval of clinical investigator's IND application to
initiate a Phase II clinical trial with oral flupirtine (EFFIRMA) for the
treatment of fibromyalgia.
-- Received FDA and IRB approvals to expand enrollment criteria for Phase
II/III clinical trial of TRIMESTA for multiple sclerosis to now include
patients that may have been previously treated with other agents.
-- Entered into preliminary supply agreement with a cGMP medical device
manufacturer and improved the commercial manufacturing process of the
disposable assay component of our FreeBound investigational medical device
for the direct measurement of free copper levels in serum and whole blood.
-- Implemented significant cost reduction measures including a 54%
reduction in headcount and additional reductions in outside consultants and
consulting expenses.
-- Recently, we received "Orphan Drug" designation from the US FDA for
Oral TTM for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
-- We received a notice of allowance for broad claims for a U.S. Patent
for Oral TTM for Alzheimer's disease.
Steve H. Kanzer, CPA, Esq., Chairman and Chief Executive Officer
of Pipex, commented, "We are looking forward to communicating the
full breadth of our product pipeline to the investment community,
potential pharmaceutical partners and acquirers. In the near term,
we anticipate the full publication of our 80-patient clinical trial
results for Z-Monocys for AMD in a peer-reviewed ophthalmology
journal. This composition-of-matter protected conjugated
zinc-cysteine complex with improved properties may have wide
application in significant disease indications beyond AMD also
involving metal dyshomeostasis. We hope to initiate a Phase II
clinical trial using oral flupirtine for the treatment of
fibromyalgia by the end of this quarter. We are pleased with the
increased enrollment rate of the Phase II/III trial of our oral
bioidentical estriol candidate TRIMESTA for MS patients, the
largest clinical trial study sponsored by the National Multiple
Sclerosis Society for any clinical candidate."
Below is a summary of our product candidates and their stages of
development:
TRIMESTA (oral, once-daily estriol)
TRIMESTA, our oral, once-daily bioidentical hormone estriol is
currently in a seven U.S. center, placebo-controlled Phase II/III
clinical trial which is expected to enroll up to 150
relapsing-remitting Multiple Sclerosis (MS) patients. TRIMESTA is
being supported under a $5 million grant from the Southern
California Chapter of the National Multiple Sclerosis Society and
NIH. Oral estriol, the active ingredient in TRIMESTA, has been
approved throughout Europe and Asia for approximately 40 years but
is not available in the U.S.
This Phase II/III clinical trial builds upon our encouraging
results from an earlier single agent Phase IIa clinical trial in
female MS patients whereby TRIMESTA demonstrated a 79 percent
decrease in MS brain lesions in 3 months (p=0.02) and a 14 percent
improvement in cognitive function as measured by the PASAT scoring
system at 6 months (p=0.04). This dataset is also supplemented by a
definitive study of the effect of pregnancy on MS, known as the
PRIMS (Rate of Pregnancy-related Relapse in Multiple Sclerosis)
which was published in the New England Journal of Medicine (NEJM)
by Confavreux et al. In that study, relapse rates were determined
in 254 women with MS during pregnancy and for up to one year after
delivery. Relapse rates were shown to be significantly reduced
during the third trimester of pregnancy, by 71 percent (p <
0.001). The relapse rates then increased to 58 percent (p <
0.001) during the first three months post-partum before returning
to prepregnancy rates. Together, these data clearly demonstrated
that the latter part of pregnancy is associated with a significant
reduction in relapses, while there is a rebound increase in
relapses post-partum. Researchers have demonstrated the estriol
levels increase to their highest levels during the third trimester,
then drop-off to nearly zero during the post-partum period.
Z-Monocys (oral zinc-monocysteine)
We are developing oral Z-monocys as a treatment for dry
age-related macular degeneration ("dry AMD"), a disease for which
there is no FDA-approved therapy. Z-monocys has completed a six
month, double-masked randomized placebo-controlled trial in 80 dry
AMD patients, with statistically significant improvements shown in
visual acuity, contrast sensitivity and photorecovery times. A
manuscript describing these results has been submitted to a leading
peer-reviewed ophthalmic journal, and on May 1, 2008 we were
notified that this manuscript has been accepted for publication. We
expect this manuscript describing these clinical trial results to
be published shortly.
EFFIRMA? (oral flupirtine)
We are developing EFFIRMA, an oral, non-opiate NMDA receptor
antagonist with potassium channel modulatory activity for the
treatment of fibromyalgia and various pain-related diseases.
Flupirtine, the active ingredient in EFFIRMA, has been commercially
approved for over 20 years in various countries in Europe for the
treatment of pain and has been used by over 1.5 million patients.
Additionally, flupirtine has been tested in 2,775 patients in
controlled clinical trial studies.
Oral flupirtine has recently received an IND with the FDA to
conduct a Phase II clinical trial with EFFIRMA in fibromyalgia
patients. We plan to fund this double-blind placebo-controlled
Phase II clinical study which is designed to enroll up to 90
patients with fibromyalgia.
Oral TTM (oral tetrathiomolybdate)
We are developing oral tetrathiomolybdate (oral TTM), an
anti-copper therapeutic compound, for the treatment of various
diseases in which there is an elevated level of "free" copper. We
continue to consider the potential use of oral TTM in the treatment
of Alzheimer's disease, Idiopathic Pulmonary Fibrosis (IPF) and
Huntington's disease, all diseases of copper dyshomeostatis. We
recently received an "Orphan Drug" designation from the FDA for the
treatment of IPF with oral TTM. We continue to make progress with
evaluating the chemistry, manufacturing and controls issues (CMC)
relating to identity, strength and purity of oral TTM.
Financial Results for First Quarter 2008:
At March 31, 2008, Pipex had cash of approximately $8.8 million,
compared to approximately $11.5 million at December 31, 2007. The
decrease of approximately $2.7 million during the first quarter of
2008 is attributable to net cash used in operations of
approximately $1.8 million, and $900,000 that we elected to use to
repay our outstanding equipment notes payable in full in order to
eliminate further monthly interest payments as well as the security
interest on our $2.0 million in equipment and leasehold
improvements primarily relating to our cGMP pharmaceutical
production facility in Ann Arbor, Michigan.
The net loss applicable to common shareholders for the quarter
ended March 31, 2008 was $3,089,456, or $0.15 per share, compared
to a net loss applicable to common shareholders of $15,259,257, or
$0.90 per share, for the comparable quarter in 2007, representing a
decrease in net loss of $12,169,801. The decrease is primarily
attributable to a non-cash charge of $12,409,722 taken during the
first quarter of 2007 related to the acquisition of Effective
Pharmaceuticals, Inc. The total of the non-cash charge was
reflected through equal and offsetting adjustments to additional
paid-in-capital with no net impact on stockholders' equity.
Research and development expenses increased by $707,497 for the
quarter ended March 31, 2008 as compared to the same period last
year. The increase primarily related to Pipex's oral TTM(TM) NDA
directed activities, as well as the further development of Pipex's
other product candidates, TRIMESTA(TM), anti-CD4 802-2,
CORRECTA(TM), SOLOVAX, Z-monocys and EFFIRMA(TM). General and
administrative expenses decreased by $501,299 for the three months
ended March 31, 2008 as compared to the first quarter of 2007 which
is primarily due to a decreased in stock-based compensation
expense.
Guidance on Current Cash Resources and Expenditures
We implemented significant downsizing and cost saving measures
announced March 11, 2008 in order to preserve our capital. Given
the severance and other trailing expenses associated with such
downsizing or discontinued oral TTM NDA activities, the full
benefit of our cost reduction measures are being fully realized now
in this mid-second quarter of 2008. Given our current cash balance
of approximately $8.2 million as of today May 15, 2008, we expect
our cash reserves to be sufficient to fund currently planned
business operations for the next 15-18 months. This guidance does
not include any potential other major transactions, including
corporate partnerships, and, should such an event or events occur
this year, financial expectations could change significantly.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. 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 to complete the further clinical testing,
manufacturing and regulatory requirements and seek marketing
authorizations. Pipex is focused on treating Dry Age Related
Macular Degeneration (AMD), multiple sclerosis, fibromyalgia,
Alzheimer's disease, Huntington's disease, and neurologic Wilson'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 and statements regarding the full publication of
an 80 patient, double-blind, placebo controlled clinical trial
results for Z-Monocys, and initiating a phase II clinical trial
using oral flupirtine for the treatment of fibromyalgia. 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, JD
Chairman and Chief Executive Officer (734) 332-7800 Charles
Bisgaier, Ph.D. President (734) 332-7800 Redington, Inc. (Investor
Relations) Thomas Redington 203-222-7399 www.redingtoninc.com
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