Medgenics Announces Encouraging Preliminary Data for Phase I/II Clinical Trial of EPODURE in Renal Anemia
03 November 2008 - 8:34PM
Business Wire
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.
Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Medgenics(Regs) (LSE:MEDG)
Historical Stock Chart
From Jul 2023 to Jul 2024