Medgenics Granted Approval to Commence Its Landmark Phase I/II Clinical Study of EPODURE to Treat Anaemia
July 30 2008 - 6:55AM
Business Wire
Medgenics (AIM:MEDG) announces that it has received approval from
Israel�s Ministry of Health (MOH) to commence its landmark Phase
I/II safety and efficacy trial of its EPODURE Biopump for providing
sustained treatment of anaemia in patients with chronic kidney
disease. Patient recruitment has now commenced for the trial, with
the first patients expected to receive their Biopumps within six
weeks. The trial is taking place at the Hadassah University Medical
Center in Jerusalem, Israel and will aim to treat up to 30
patients. This study aims to assess the safety and efficacy of
EPODURE at increasing, controlled dose ranges, in providing
sustained, elevated levels of the deficient protein erythropoietin
(EPO) and, thereby, in elevating the red blood cell count and
hemoglobin levels for up to 4�6 months in those patients receiving
appropriate doses. The first patients are scheduled to receive the
lowest dose range of up to 20 Units of EPO per kilogram per day.
Once an interim review has confirmed initial safety in at least 6
patients, higher doses of 40 and 60 Units are planned. Commenting
on the approval Dr. Andrew Pearlman, Chief Executive Officer of
Medgenics, said: �This is clearly the most important milestone for
Medgenics since its admission to AIM, as our primary focus this
past year has been to prepare for this key clinical trial. This
study aims to demonstrate not only the basic safety and efficacy of
EPODURE for treating anaemic patients but, more broadly, to prove
the concept of our Biopump platform technology as an innovative
approach for treating chronic diseases. We are very pleased to have
received this important approval from the MOH and look forward to
recruiting the first patients and to reporting initial results
within 3�5 months after they receive their own EPODURE implants.
This key approval moves Medgenics closer to proving the proprietary
platform technology to enable patients to produce their own natural
human protein therapy for treatment of a range of chronic diseases,
and should strengthen Medgenics� position for strategic
partnering.� 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 anaemic patients. A long-acting version of
EPODURE, designed to produce and deliver a therapeutic dose of EPO
steadily for six months or more, entered a Phase I/II trial in
mid-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
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