Medgenics on Target to Start Phase I/II Clinical Trials With EPODURE Protein Therapy for Anaemia Mid-2008 as Planned
April 14 2008 - 2:15AM
Business Wire
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
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