Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jul 2019 to Jul 2024
Medgenics (AIM:MEDG), is pleased to announce encouraging preliminary
data for its Phase I/II clinical trial.
The landmark Phase I/II clinical trial of Medgenics’
EPODURE Biopump, for providing sustained treatment of anemia in subjects
with chronic kidney disease, is underway. The current trial is designed
to assess the safety and efficacy of the EPODURE Biopump in providing
sustained elevation of hemoglobin by delivering sufficient supplemental
amounts of the protein erythropoietin (EPO) for 3–6
months. Each subject will be monitored for 6 months after the EPODURE
implantation. Further applications of the Biopump platform technology
will be developed and tested from 2009 onwards.
The first month’s data from the on-going Phase
I/II trial has now been collected from the initial two anemic, chronic
kidney disease subjects receiving the lowest dose in this dose
escalating study. One subject received 2 and the other 3 Biopumps,
reflecting the respective number needed to provide the intended low
daily EPO dose of 18-25 IU/kg/day in each subject. The hemoglobin levels
of each of these subjects have risen and remain within the target range
of between 10 and 12 grams per deciliter for a month, with no adverse
effects reported or observed, other than minor localized bruising
typically associated with skin biopsy and implant. The 10-12 grams per
decilitre range is what is recommended for such patients to treat their
anemia. As the trial progresses these subjects will continue to be
monitored, additional subjects will be enrolled and further data will be
reported as key milestones are achieved. The Directors expect to
commence testing on further subjects before the end of 2008.
The Directors are encouraged by the fact that, although the trials are
at an early stage, the elevated hemoglobin levels seen in the 2 subjects
currently participating in the trial suggest that immunogenicity issues
have not been encountered thus far. Immunogenicity is the triggering of
a natural immune response by the human body which could halt the protein
production of the Biopump and which is thought to have curtailed the
duration of EPO delivery in the Company’s
previous Phase I Clinical Trials, in 2003. In the previous trial,
elevated hemoglobin levels were not seen despite dosage levels at least
three times higher than those used thus far in the current trial. The
Directors believe that the elevated hemoglobin levels and the apparent
immune acceptance of the implanted EPODURE Biopumps, should be viewed
positively, although more definitive conclusions can only be drawn once
more subjects have been tested for a longer period.
Medgenics’ Biopump is a unique tissue-based
platform technology that processes a toothpick sized sliver of the inner
layer of the subject’s skin and is designed to
provide sustained-action protein therapy for the treatment of a range of
chronic diseases. As stated in the Company’s
Admission Document London AIM Exchange, the Directors believes that the
Biopump platform technology will provide a wide range of advantages over
existing protein therapies that will appeal and offer benefits to
doctors, patients and third party payers (e.g. medical insurers). These
advantages include:
Increased efficacy
Improved safety
Reversible treatment
Reduced side effects
Lower costs
Elimination of frequent injections
Extended treatment to undertreated populations
Additional subjects are being actively recruited for this study taking
place at Hadassah Hebrew University Hospital in Jerusalem, Israel, which
aims to test the technology on up to 30 subjects by the end of 2009.
These initial results will be presented at Renal Week 2008, the American
Society of Nephrologists annual meeting and scientific exposition, in
Philadelphia, Pennsylvania, USA on November 4-9, 2008. Dr. Michal
Dranitzki Elhalel, principal nephrologist in the study will present on
Thursday, November 6, 2008 at 4:45 p.m. at the Clinical Nephrology
Conference and Medgenics Senior Scientists will present Medgenics’
GMP vector and Toxicity Study in the Poster Session on Saturday,
November 8, beginning at 10:00 am, at the Pennsylvania Convention Center.
Commenting on the preliminary results, Dr. Andrew Pearlman, Chief
Executive Officer of Medgenics, said:
“While early data from the first two subjects
is only a first indicator from this 30 subject study, we are encouraged
that this study will show that Medgenics’
EPODURE Biopump can be used to safely elevate hemoglobin levels in
subjects with chronic kidney disease for three to six months (or more)
from a single implant of one or more Biopumps. We look forward to
reporting further as the study proceeds but, given the data collected
and the apparent lack of an adverse immune response to the technology so
far, we are cautiously optimistic that the trial will support the
Directors’ belief in this breakthrough
platform technology.”
NOTES TO EDITORS:
Medgenics, Inc. is a clinical-stage biopharmaceutical company developing
its unique tissue-based Biopump platform technology to provide
sustained-action protein therapy for the treatment of a range of chronic
diseases.
Medgenics currently has two products in development based on this
technology:
EPODURE – producing erythropoietin (EPO) to
treat anaemia
INFRADURE – producing interferon-alpha (IFN-?)
to treat hepatitis C
The Company has demonstrated proof of principle of the Biopump treatment
procedure in a clinical trial using a short-acting version of EPODURE in
anemic subjects. The Company commenced a Phase I/II clinical trial for
its long-acting version of EPODURE, designed to produce and deliver a
therapeutic dose of EPO steadily for three to six months or more, in
August 2008. The Company plans to follow with a clinical trial of
INFRADURE in 2009.
Medgenics intends to develop its innovative products and bring them to
market via multiple strategic partnerships with major pharmaceutical
and/or medical device companies, starting with EPODURE and INFRADURE.
Beyond these, Medgenics plans to develop and/or out-license a pipeline
of future Biopump products targeting the large and rapidly growing
global protein therapy market, which is forecast to reach US $87 billion
by 2010. Other potential areas include multiple sclerosis (interferon-?),
haemophilia (Factor XIII), paediatric growth hormone deficiency (human
growth hormone) and diabetes (insulin).
Founded in 2000, Medgenics is a US-incorporated company with major
operations in Misgav, Israel. Medgenics was admitted to AIM in December
2007 (AIM:MEDG).
www.medgenics.com
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, which include all
statements other than statements of historical fact, including (without
limitation) those regarding the Company’s
financial position, business strategy, plans and objectives of
management for future operations. These statements relate to future
events, prospects, developments and strategies. 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.