Higher Dose EPO Biopumps Working in Patients
22 June 2010 - 4:30PM
UK Regulatory
TIDMMEDG
RNS Number : 9877N
Medgenics Inc
22 June 2010
Medgenics, Inc.
('Medgenics' or the 'Company')
Higher Dose EPO Biopumps Working in Patients
Misgav, Israel and London, UK -22 June 2010 - Medgenics, Inc. (AIM: MEDG, MEDU),
the company that has developed a novel technology for the manufacture and
delivery of therapeutic proteins continuously in patients using their own
tissue, is pleased to announce that the first new patients have now successfully
commenced their treatment using biopumps producing middle dose levels of EPO in
the Company's ongoing Phase I/II clinical trials with EPODURE. The new patients
were also the first to have their Biopumps prepared at a remote site (the GMP
processing center in Jerusalem), transported in a sealed chamber and
subsequently administered locally at a major teaching hospital in Tel Aviv -
thus successfully demonstrating the concept of a regional Biopump processing
center serving a local treatment center, which is important for the wider
implementation planned in the future.
In the first part of the Company's Phase I/II clinical trial, completed in 2009
at the Hadassah Medical Center in Jerusalem, the equivalent of the lowest
recommended dose for EPO (20 IU/kg/day) was prepared at the local GMP center and
administered in 6 of the patients treated and one patient was treated with the
middle recommended dose (40 IU/kg/day). The biopumps produced EPO continuously
in all the patients, elevating or maintaining the haemoglobin levels in many,
even with the lowest EPO dose, with most continuing for the 6 month duration of
the trial and one for more than 20 months.
This second part of the trial is being conducted at the Tel Aviv Medical Center,
and is aimed at treating new patients with the medium and higher continuous
doses to confirm that haemoglobin will be maintained or elevated over the period
of the trial at higher dosage levels of EPO delivery. Demonstrating elevation
of the haemoglobin level and its maintenance within the normal therapeutic range
are primary objectives of this trial.
In this new stage of the continuing Phase I/II clinical trial, sufficient
EPODURE biopumps will be administered to each patient to provide 40 IU/kg/day.
Two weeks ago, the team conducting the trial at Tel Aviv Medical Center
successfully harvested micro-organs from the first two new patients entering the
study and processed them to become EPODURE biopumps. These biopumps produced
sufficient EPO per day that only 3 or 4 biopumps were necessary in each patient,
and these were administered to them on June 17.
The treatment of these new patients is possible as a result of the recently
announced, successful fundraising rounds. The Company is now delivering on its
plan to move forward with these trials, which have already demonstrated safety
and proof of concept of the EPODURE biopump, and now aim to show a trend of
greater haemoglobin responses with the higher doses administered. Following the
implantation, the EPO measurements from the post-implant blood samples have
confirmed a significant rise in serum EPO levels, demonstrating that the
biopumps are efficiently delivering the protein in these patients. In the
previous part of this trial, confirmed EPO production in situ was followed by an
elevation of haemoglobin levels within the ensuing months and the Company is
confident that this will also happen in this higher dose stage of the trial.
Dr. Andrew Pearlman, CEO of Medgenics commented: "We are very pleased that the
first patients in the new part of our study have now commenced their treatment.
We are particularly impressed with the potency of the EPODURE biopumps from
these patients, which has enabled them to receive the medium dose using only a
few biopump units, and with their successful preparation at a remote site
Biopump processing center, establishing a model for wider future implementation.
We now look forward to monitoring the haemoglobin response in these patients,
while recruiting additional patients to the trial in the coming months. We are
optimistic that this higher dose will confirm that the middle dose biopumps work
well and that the therapeutic response is dose dependent and without adverse
effects. As this is an open trial, we look forward to keeping investors updated
as we treat additional patients and review the ongoing trial data."
For further information, contact:
Andrew Pearlman +972 4 902 8900
CEO
Medgenics, Inc
Mike Wort / Anna Dunphy +44 207 861 3838
De Facto Communications (PR)
James Pinner / Derek Crowhurst +44 207 444 0800
Religare Capital Markets (Nomad)
Ian Callaway / Alex Mattey +44 207 638 5600
SVS Securities plc (Joint Broker)
Jonathan Senior +44 207 776 1219
Nomura Code (Joint Broker)
Notes to Editors:
Medgenics is a commercial-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. The first revenue
generating commercial deal with a well known multinational pharmaceutical
company was negotiated in late 2009.
Biopumps are made using needle biopsies taken from the lower layer of the
patient's skin under local anaesthetic, and processed during 10-14 days to
become 30 mm long tissue "biofactories" producing the required protein. The
requisite number of Biopumps are injected under the patient's skin to provide
sustained protein production and delivery for many months. The Company is
developing the Biopump to provide substantially greater safety and reliability
in protein treatment in a more cost effective manner than experienced with the
existing injected protein therapies. Medgenics currently has three products in
development based on this technology, addressing the indications of:
- Anaemia - using EPODURE, a Biopump producing erythropoietin (EPO)
- Hepatitis-C - using INFRADURE - a Biopump producing interferon-alpha (IFN-a)
- Haemophilia - using a Biopump to produce clotting Factor VIII
The Company's Phase I/II clinical trial using EPODURE to treat anaemia in
patients with chronic kidney disease, has demonstrated proof of concept of the
Biopump. Designed to produce and deliver a therapeutic dose of EPO steadily for
six months or more, EPODURE Biopumps have already provided effective anaemia
treatment in most of the longest participating patients for 6-12 months, even at
the low administered dose.
Medgenics intends to develop its innovative products and bring them to market
via multiple strategic partnerships with major pharmaceutical and/or medical
device companies. In addition to treatments for Anaemia, Hepatitis-C and
Haemophilia, 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 the end of 2010. Other
potential applications of Biopumps producing various proteins include multiple
sclerosis, arthritis, pediatric growth hormone deficiency, obesity, and
diabetes.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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