Medgenics(Regs) (LSE:MEDG)
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Medgenics (AIM:MEDG), the US-incorporated biopharmaceutical company, is
pleased to provide an update on progress towards the start of its Phase
I/II clinical trials with EPODURE, its lead sustained-action protein
therapy for producing and delivering erythropoietin (EPO) to treat
anaemia.
The Company continues to make excellent progress with its preparations
to commence Phase I/II trials of EPODURE and remains confident it will
begin these trials by mid-2008 as planned. In addition, Medgenics
expects to obtain the key initial safety and proof of efficacy data for
EPODURE within 3–5 months after the trial
commences.
Medgenics submitted its application for approval of the Phase I/II
trials of its EPODURE protein therapy to the Israel Ministry of Health
(MoH) in February 2008. The application is currently in active review by
MoH and Medgenics anticipates that approval will be obtained in good
time to enable the trials to commence mid-year. EPODURE is Medgenics’
lead product in development, designed to provide a sustained-action
protein therapy for producing and delivering EPO continuously for a
period of 4–6 months or longer to treat
anaemia in patients with chronic kidney disease.
The Phase I/II clinical trials are designed to generate key initial
safety and proof of efficacy data for EPODURE, and are planned to take
place at the Hadassah Hospital in Jerusalem, Israel. In September 2007,
Medgenics received initial approval of its trial protocol from the
Ethics Committee of Hadassah Hospital, conditional upon final approval
from MoH.
Medgenics’ application for approval of the
trials parallels the Company’s achievement of
several important milestones in recent months, which are crucial to
allow the trial to begin:
1. The successful manufacture of the key “gutless”
adenoviral vector in a GMP (“Good
Manufacturing Practice”) vector production
facility. This vector, now in the last phases of external testing, has
passed the Company’s internal tests, in which
it was used to prepare EPODURE biopumps from human dermis “micro-organs”
to produce sufficient daily amounts of EPO to meet the Company’s
requirements for use in the trial.
2. Completion of the design, fabrication and evaluation of the key
proprietary devices it will use for harvesting patient micro-organs and
implanting biopumps, including EPODURE, back into patients.
3. The recruitment of key additional scientific and engineering
personnel, increasing the staff complement from four at Admission to ten
now, in accordance with its plan and preparations for the Phase I/II
clinical trial for EPODURE.
4. The relocation of the Group’s operations
to a new facility on the Teradion Business Park in Misgav, thereby
bringing all operations under one roof.
Dr. Andrew Pearlman, Medgenics’ CEO, said:
“Since Admission to AIM in December 2007,
preparations for the Phase I/II clinical trials of our EPODURE biopump
technology for treating anaemia have gone very well. The successful
results we hope and believe we will achieve in these trials will be a
transforming event for Medgenics and we are confident that, subject to
timely approval by the Israel Ministry of Health, they will start as
planned in the middle of the year.”
NOTES TO EDITORS:
About Medgenics
Medgenics, Inc. is a 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
anaemic patients. A long-acting version of EPODURE, designed to produce
and deliver a therapeutic dose of EPO steadily for six months or more,
is scheduled to enter Phase I/II trials in mid-2008. The Company plans
to follow with clinical trials 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
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phrases such as “estimate,”
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“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.