ANN ARBOR, MI , a specialty pharmaceutical company developing
innovative late-stage drug candidates for the treatment of central
nervous system and autoimmune diseases, today announced results and
publication of positive double-blind, placebo-controlled clinical
trial results in the treatment of dry age-related macular
degeneration (AMD) with oral Zinthionein(TM) (formerly Z-Monocys,
zinc-monocysteine), meeting all global central retinal function
measurements of the clinical trial. Dry AMD is the leading cause of
blindness in the U.S., affecting approximately 10 million Americans
and has no FDA approved therapy.
In order to participate in the webcast/conference call, please
call toll free: (US): 800-952-4972; international dial-in:
416-641-2140, conference ID: Pipex. A visual presentation will be
available at: http://www.visualwebcaster.com/event.asp?id=49757.
The audio recording and visual presentation will be available for
replay at http://www.pipexinc.com for a period of at least 15 days
after the call.
After six (6) months, compared to placebo treated patients,
Zinthionein treated patients demonstrated a highly statistically
significant improvement in visual acuity (p < 0.0001), contrast
sensitivity (p <
0.0001) as well as photorecovery time (p=0.0001), each of which
represent carefully measured endpoints of global central retinal
function that is compromised in AMD.
The following table represents the results of the visual acuity
endpoint as measured by ETDRS on a per eye basis at month 6:
Change from Baseline 6 month
at 6 months (Placebo vs.
Eye (Mean +/- SEM) Zinthionein therapy)
Right (Zinthionein group) 4.405 +/- 0.712 p < 0.0001
Right (Placebo) -1.054 +/- 0.489
Left (Zinthionein group) 3.057 +/- 0.639 p < 0.0001
Left (Placebo ) -0.703 +/- 0.642
The following table represents the results of the contrast
sensitivity endpoint of the study on a per eye basis at month
6:
Change from Baseline 6 month
at 6 months (Placebo vs.
Eye (Mean +/- SEM) Zinthionein therapy)
Right (Zinthionein group) 0.199 +/- 0.045 p < 0.0001
Right (Placebo) -0.039 +/- 0.029
Left (Zinthionein group) 0.159 +/- 0.029 p < 0.0001
Left (Placebo ) -0.035 +/- 0.025
The following table represents the results of the photo recovery
time endpoint of the study on a per eye basis at month 6:
Change from Baseline 6 month
at 6 months (Placebo vs.
Eye (Mean +/- SEM) Zinthionein therapy)
Right (Zinthionein group) -7.351 +/- 0.911 p < 0.0001
Right (Placebo) 0.189 +/- 0.673
Left (Zinthionein group) -7.171 +/- 1.149 p < 0.0001
Left (Placebo ) 0.541 +/- 0.597
Zinthionein appeared to be well tolerated in the study, with
only a two percent (2%) gastrointestinal irritation rate as
compared to placebo.
David A. Newsome, M.D., a board certified ophthalmologist,
former Head of the Retinal Disease Section of the National Eye
Institute (NEI), co-inventor of Zinthionein, primary investigator
of the clinical trial, and a scientific advisor to Pipex commented,
"I believe these results are striking in that significant dry AMD
improvement can be achieved rapidly with Zinthionein. It is very
rare for a phase II Dry AMD study to demonstrate significance on
all of the measurements of global retina function with strong
statistical significance. I look forward to continued collaboration
with the Pipex team to further develop Zinthionein as a potential
new therapy for Dry AMD."
Nicholas Stergis, Chief Executive Officer of Pipex, commented,
"We are pleased to report these results and we believe this is a
significant step forward for the 10 million Americans affected with
Dry AMD whose therapeutic options are limited. Zinthionein builds
upon Dr. Newsome's original hypothesis of zinc deficiency in AMD,
which formed the basis for the National Eye Institute's successful
Age-Related Eye Disease Study (AREDS), the largest study ever
conducted in AMD and which confirmed a protective role for zinc in
AMD. In addition to providing zinc, Zinthionein incorporates Dr.
Newsome's more recent hypothesis of supplying the retina with a
metabolically active form of cysteine as a necessary precursor to
boost the potent retinal antioxidant system, glutathione (GSH),
considered by Dr. Newsome to be the second most important
protective system against oxidative free radicals present in the
retinal pigment epithelium (RPE) and other retinal tissues. The
combination of these important features may make Zinthionein an
important new treatment option for Dry AMD patients as well as
additional important indications which also may involve metal
dyshomeostasis that we are currently exploring."
Mr. Stergis continued, "We look forward to reporting additional
data from studies conducted with Zinthionein, along with our
commercialization plans for this compound."
Zinthionein Capsules
Zinthionein Capsules (oral zinc-monocysteine) is a novel
composition-of-matter patent protected complex of zinc and
cysteine, ingredients which are currently generally regarded as
safe (GRAS). Zinthionein is covered by issued U.S. patents
7,164,035 and 6,586,611 which provide composition-of-matter
protection through the year 2020 (or 2025 with patent term
extension, if available) as well as additional pending U.S. and
international patent applications. For further information on
Zinthionein, please review the below references (1),(2).
About the Clinical Trial Design
Zinthionein capsules (25mg capsules twice daily) were compared
to placebo capsules twice daily on a 1:1 randomization scheme in a
prospective, randomized, double-blind, placebo-controlled trial
involving a total of 80 Dry AMD patients for period of six (6)
months at a single site. All patients had drusen, including medium
size drusen. Patients displaying signs of choroidal neovascular
activity (i.e. the wet form of AMD) were excluded. The average age
of participants 73.3 years of age in Group 1 (placebo) and 72.1
years of age in Group 2 (Zinthionein). Functional assessment
included best-corrected visual acuity determined by blinded trained
examiners using an internally lighted ETDRS logMar chart and ETDRS
procedures. Visual acuity was recorded as number letters correctly
identified with best correction. Contrast sensitivity was
determined at 1 meter using a calibrated Pelli Robson chart in 85
cd/m2 lighting also with best correction using standard
methodology. Results were recorded as the log contrast sensitivity
from the Pelli Robson alogorithm. Photorecovery times were
determined using a device invented by Dr. Newsome (U.S. Patent
6,863,399) that delivered a reproducible bleaching flash to the
macula with built-in verification to assure that the subject
correctly identified the endpoint stimulus. Results were recorded
as seconds (time) required to recover from a flash-induced glare
sufficiently to identify new stimuli presented by the device.
Reprints of the complete study details, demographics and clinical
macular characteristics of subjects and detailed results are
available in the publication are available online for immediate
download from the publisher in the July issue of the peer-reviewed
ophthalmology journal, Current Eye Research (1).
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 Dry
Age-Related Macular Degeneration (AMD), multiple sclerosis (MS),
and fibromyalgia. For further information, please visit
www.pipexinc.com.
(1) Newsome DA, A Randomized, Prospective, Placebo-Controlled
Clinical Trial of a Novel Zinc-Monocysteine Compound in Age-Related
Macular Degeneration, Current Eye Research, Vol. 33, Iss. 7 July
2008 pp. 591:598.
(2) Tate DJ, Newsome DA, A novel zinc compound
(zinc-monocysteine) enhances the antioxidant capacity of human
retinal pigment epithelial cells. Curr Eye Res. 2006
Jul-Aug;31(7-8):675-83.
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 March 31, 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 Redington, Inc. (Investor
Relations) Thomas Redington 203-222-7399 www.redingtoninc.com
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