Clinical Trial Information
April 27 2010 - 4:30AM
UK Regulatory
TIDMMEDG
RNS Number : 8434K
Medgenics Inc
27 April 2010
Medgenics, Inc.
('Medgenics' or the 'Company')
MEDGENICS GRANTED APPROVAL FOR EXTENSION OF ANAEMIA TRIAL TO MAJOR NEW MEDICAL
CENTRE
Misgav, Israel and London, UK -27 April 2010 - Medgenics (AIM: MEDG, MEDU) is
pleased to announce that it has received approval from Israel's Ministry of
Health (MOH) to proceed with higher dose groups in the phase I-II clinical trial
of its novel sustained anaemia treatment, EPODURE, at an additional new site,
the Tel Aviv Sourasky Medical Centre, one of the largest teaching hospitals in
Israel. Following the first closing of the Company's interim fund raising, as
announced on 5 March 2010, patient recruitment will commence shortly for the new
centre, with the first patients expected to receive their Biopumps within a few
weeks of enrollment. Medgenics has already reported sustained anaemia treatment
of unprecedented duration from a single treatment in most patients in the low
dose group in this study and hopes to prove the efficacy of EPODURE further in
this higher dose study.
The new higher dose study groups aim to assess the safety and efficacy of
EPODURE at increased, controlled dose ranges, noting that among the seven
patients already treated in the Company's clinical trial to date, no signs of
adverse reactions have been noted, and all patients tolerated all study
procedures very well. From the clinical efficacy perspective, the six patients
in the low dose group received sufficient EPODURE Biopumps to provide the lowest
recommended dosage of erythropoietin (EPO) on a continuous basis: 20 EPO units
or IU/kg/day. All patients showed delivery of active EPO, with most showing
sustained elevation of haemoglobin levels (the primary endpoint) in the target
range of 10-12 g/dl for 6-12 months, without receiving any further injections of
EPO. One of these patients maintained haemaglobin levels in the normal range
for more than 18 months without any EPO injections. The seventh patient has
already received the midrange dose of 40 IU/kg/day and also maintained
haemoglobin levels for six months without adverse events.
Medgenics' unique platform approach to providing safer, more effective and lower
cost protein therapy uses the patient's own tissue to act as a biological pump
or "Biopump" to continuously produce their own therapeutic proteins. Needle
biopsies are taken from the lower layer of the patient's skin under local
anesthetic, and processed during 10-14 days to become tissue biofactories
producing the required protein. The requisite number of Biopumps are then
injected under the patient's skin to provide sustained protein production and
delivery for many months.
In the next dose group of the study, sufficient EPODURE Biopumps will be
administered to each patient to provide 40 IU/kg/per day or 60 IU/kg per day,
which may enable more of the patients to maintain haemaglobin in the target
range for extended periods of time. Dr. Doron Schwartz, Head of the Nephrology
department at the centre, as the new Principal Investigator, has already
recruited the active support of his department for the study.
Commenting on the approval, Dr. Andrew Pearlman, Chief Executive Officer of
Medgenics, said:
"The extension of our study to one of Israel's largest and most prestigious
medical centres is an important milestone for EPODURE and the Medgenics Biopump
platform technology for the continuous production and delivery of therapeutic
proteins in the patient. This important step has been made possible by the
encouraging results achieved to date, together with the first closing of our
current round of fundraising, and we look forward to moving ahead on this and
other steps in our program as additional funds are raised in the coming months.
The enthusiastic involvement of Dr. Schwartz and his department is particularly
welcomed as we proceed towards completion of this trial in a timely manner, and
we hope that we will now have more rapid patient recruitment than we have had to
date.
Given the very encouraging results at low dose levels, we are looking much
forward to seeing the results from the higher doses in this trial."
For further information, contact:
+----------------------------------+--------------------------+
| Medgenics, Inc. | Phone: +972 4 902 8900 |
| Dr. Andrew L. Pearlman | |
| | |
+----------------------------------+--------------------------+
| De Facto Communications | Phone: +44 207 861 3838 |
| Mike Wort | |
| Anna Dunphy | |
| | |
+----------------------------------+--------------------------+
| Religare Capital Markets (Nomad) | Phone: +44 207 444 0800 |
| James Pinner | |
| Derek Crowhurst | |
| | |
+----------------------------------+--------------------------+
+----------------------------------+--------------------------+
| SVS Securities plc (Broker) | Phone: +44 207 638 5600 |
| Alex Mattey | |
| Ian Callaway | |
| | |
+----------------------------------+--------------------------+
NOTES TO EDITORS:
Medgenics is a pre-revenue, commercialization stage biopharmaceutical company
developing its unique tissue-based Biopump platform technology capable of
producing and delivering months of sustained protein therapy. A single
administration of Biopump has already been shown to provide at least 6-12 months
of safe, effective, treatment in its first application in patients. Biopumps
could potentially provide safer, more effective and lower cost treatment for a
wide range of chronic diseases. The Company, which has signed its first
commercial development agreement with a major Pharmaceutical company which is
now in progress, currently has three products in development based on this
technology and addressing the indications of:
- Anaemia - using EPODURE, a Biopump producing erythropoietin (EPO) - Has proven
concept in clinical trials.
- Hepatitis-C - using INFRADURE - a Biopump producing interferon-alpha (IFN-a)
- Proven in the lab, in preclinical preparations.
- Haemophilia - using a Biopump to produce clotting Factor VIII - under
development with a major Pharmaceutical company that is a leader in the
haemophilia market.
In the Company's Phase I/II clinical trial using EPODURE to treat anaemia in
patients with chronic kidney disease, 6-12 months of effective anaemia treatment
from a single treatment of a few Biopumps has already been shown in most of the
patients treated, even at the lowest administered dose. Taken together with the
EPODURE results, the production of IFN-a by INFRADURE demonstrates that the
Biopump is a platform for sustained protein therapy in a range of applications.
While developing its innovative products, Medgenics has already reached its
first commercial development agreement in its strategy of forging multiple
strategic partnerships with major pharmaceutical and/or medical device companies
to bring products thru final approval and sales. Medgenics is developing its
core technology to implement automated Biopump processing stations employing
single use cassettes, to enable practical and cost-effective scale-up for
commercial implementation. In addition to treatments for Anaemia, Hepatitis-C,
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, forecast to exceed US $80 billion in 2010. Other pipeline Biopump
applications include multiple sclerosis, obesity, diabetes, arthritis, and
paediatric growth hormone deficiency, among others.
www.medgenics.com
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