Medgenics Inc Positive Interim Data from Phase IIa EPODURE Study (2458D)
25 Abril 2013 - 8:15AM
UK Regulatory
TIDMMEDG TIDMMEDU
RNS Number : 2458D
Medgenics Inc
25 April 2013
Press Release 25 April 2013
Medgenics Reports Positive Interim Results from Ongoing Phase
IIa Study of EPODURE to Treat Anemia in Dialysis Patients
Data will be used to support Phase II trial in U.S.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the
"Company"), the developer of Biopump(TM), a novel technology for
the sustained production and delivery of therapeutic proteins in
patients using their own tissue, today provided an update on
results from the first four patients treated thus far in its
ongoing Phase IIa clinical trial in Israel of EPODURE(TM) Biopumps
to treat anemia in patients on dialysis with end-stage renal
disease ("ESRD").
Each of the four patients had been receiving routine EPO
injections with each dialysis session until his or her EPODURE
Biopumps were administered by subcutaneous implantation. Initial
and on-going experience to date in ESRD patients is in line with
observations from the Company's prior Phase I/II study in anemic
pre-dialysis patients with chronic kidney disease ("CKD"). To date,
there have not been any procedure or drug related serious adverse
events. Thus far in this single treatment study, each patient has
received a single administration of EPODURE Biopumps, measured to
produce between 19 to 51 IU EPO per kg per day, in place of the
serial injections of EPO or ESA the patient had been receiving with
each dialysis session. Following the administration of EPODURE
Biopumps, the hemoglobin in these patients remained in the desired
9-11 g/dl range for approximately 2-4 months, without needing any
EPO or other ESA injections. Notably, at no point following EPODURE
treatment did the concentration of EPO in the serum of the patients
exceed the typical normal range and always remained under 100
mU/ml.
As the first study with EPODURE Biopumps in ESRD patients on
dialysis, this Phase IIa study is testing administration techniques
and dosing to determine how long a single treatment using EPODURE
Biopumps can replace the periodic injections of EPO or other
erythropoietic stimulating agents ("ESAs") currently used in the
standard care of such patients, while maintaining the patient's
hemoglobin within the desired range. The current standard of care
for ESRD patients on dialysis involves EPO or ESA injections with
each dialysis session, which is typically three times per week.
Each injection is short-lived, typically causing an extreme
transient elevation of EPO in the patient's blood to levels of
several thousand milliUnits/ml, typically 10-100 times the normal
physiological levels, followed by a decline to ineffective levels
within a few days, so the patient may not have sufficient EPO or
ESA until the next injection. The high transient levels of EPO in
the blood are a source of potential safety concern to many medical
experts as well as to the U.S. Food and Drug Administration
("FDA"), and is in marked contrast with the normal EPO levels
maintained with EPODURE, as reported above.
"These preliminary data are encouraging and we believe they will
be valuable as we move forward with plans to implement a larger
Phase II trial in the U.S. in the second half of 2013. When EPODURE
reaches routine clinical use, we believe the ability to titrate the
dose to reach the most effective dosing level based on the
patient's early hemoglobin response could further extend the
duration of hemoglobin maintenance," stated Andrew L. Pearlman,
Ph.D., President and Chief Executive Officer of Medgenics.
"EPODURE Biopumps aim to provide a cost-effective way to
maintain hemoglobin within a target range in anemic patients by
providing sustained delivery of EPO within the normal physiological
range, while avoiding the extreme elevations seen with repeat
injections. We believe that EPODURE could improve the safety and
efficacy of anemia treatments while enhancing patient quality of
life by providing a more reliable treatment that reduces or
eliminates the need for frequent EPO or ESA injections, and also
could provide clear cost benefits to payers," added Dr.
Pearlman.
About Medgenics
Medgenics is developing and commercializing Biopump(TM), a
proprietary tissue-based platform technology for the sustained
production and delivery of therapeutic proteins using the patient's
own tissue for the treatment of a range of chronic diseases
including anemia, hepatitis and hemophilia, among others.
Forward-looking Statements
This release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995, which
include all statements other than statements of historical fact,
including (without limitation) those regarding the Company's
financial position, its development and business strategy, its
product candidates and the plans and objectives of management for
future operations. The Company intends that such forward-looking
statements be subject to the safe harbors created by such laws.
Forward-looking statements are sometimes identified by their use of
the terms and phrases such as "estimate," "project," "intend, "
"forecast," "anticipate," "plan," "planning, "expect," "believe,"
"will," "will likely," "should," "could," "would," "may" or the
negative of such terms and other comparable terminology. All such
forward-looking statements are based on current expectations and
are subject to risks and uncertainties. Should any of these risks
or uncertainties materialize, or should any of the Company's
assumptions prove incorrect, actual results may differ materially
from those included within these forward-looking statements.
Accordingly, no undue reliance should be placed on these
forward-looking statements, which speak only as of the date made.
The Company expressly disclaims any obligation or undertaking to
disseminate any updates or revisions to any forward-looking
statements contained herein to reflect any change in the Company's
expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
As a result of these factors, the events described in the
forward-looking statements contained in this release may not
occur.
- Ends -
For further information, contact:
Medgenics, Inc. Phone: +972 4 902 8900
Dr. Andrew L. Pearlman
Andrew.pearlman@medgenics.com
LHA Phone: +1 212-838-3777
Anne Marie Fields
afields@lhai.com
Abchurch Communications Phone: +44 207 398 7719
Adam Michael
Joanne Shears
Jamie Hooper
Jamie.hooper@abchurch-group.com
Nomura Code Securities (NOMAD & Joint Phone: +44 207 776 1200
Broker)
Jonathan Senior
Giles Balleny
SVS Securities plc (Joint Broker) Phone: +44 207 638 5600
Alex Brearley
This information is provided by RNS
The company news service from the London Stock Exchange
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