Clinical Trial - Latest Results
March 27 2009 - 2:09AM
UK Regulatory
TIDMMEDG
RNS Number : 5911P
Medgenics Inc
27 March 2009
Medgenics, Inc.
('Medgenics' or the 'Company')
MEDGENICS' PHASE I/II CLINICAL TRIAL NOW SHOWS EPODURE CONTINUOUS
ANEMIA TREATMENT LASTING 5 MONTHS IN KIDNEY DISEASE PATIENTS
* Results to be presented at Israel Society of Nephrology Conference
* EPODURE safety and efficacy now reach 5 months from single treatment
* Data continue to indicate that Biopump may offer alternative to scores of
expensive injections
March 27, 2009 - Medgenics (AIM: MEDG) is pleased to announce that the
latest, encouraging results of the Company's ongoing EPODURE Biopump Phase I/II
Clinical Trial will be presented at the 45th Conference of the Israeli Society
of Nephrology and Hypertension, in Israel on March 27, 2009.
The latest results of the trial show that in the first 2 of the patients
treated, the hemoglobin level has now remained continuously in the target range
of 10-12 g/dl for more than 5 months following a single EPODURE treatment using
the lowest dose of 20 IU/kg/day, thus effectively treating their anemia without
receiving any injections of erythropoietin (EPO) during this period. One of the
patients received his last EPO injection more than 200 days ago. This is
contrasted with the FDA approved standard regimen of thrice weekly EPO
injections, in which typical patients would expect to receive up to 85
injections in this timeframe.
A total of 7 patients have now been treated, with 6 patients receiving
treatment for more than one month. The seventh patient is the first to
receive the higher dose of 40 IU/kg/day, which is double that of the lowest
dosage, and the higher dose treatment is proceeding smoothly. There continue to
be no adverse events reported in the study. Patient recruitment continues for
the higher dose treatment.
The new data will be presented at the conference by Dr. Michal Dranitzki
Elhalel, the principal nephrologist of Medgenics' EPODURE Phase I/II clinical
trial, currently taking place at the Hadassah Hebrew University Hospital in
Jerusalem, Israel.
The trial's sponsors and Principal Investigators are now seeking approval to
broaden the study to include dialysis patients as well as pre-dialysis patients.
More information on this will be announced as developments proceed.
The Company's active discussions with major potential strategic partners have
expanded since the announcement in February, with additional companies having
expressed interest in one or more applications.
For further information, contact:
+----------------------------------------+----------------------------------------+
| Medgenics, Inc. | Phone: +972 4 902 8900 |
| Dr. Andrew L. Pearlman | |
| | |
+----------------------------------------+----------------------------------------+
| Grayling (Financial PR, UK) | Phone: +44 207 255 5406 |
| Jonathan Shillington | Jonathan.shillington@uk.grayling.com |
| Alistair Scott | |
| | |
+----------------------------------------+----------------------------------------+
| Blomfield Corporate Finance Limited | Phone: +44 207 489 4500 |
| (Nominated Adviser) | |
| James Pinner | |
| Alan MacKenzie | |
| | |
+----------------------------------------+----------------------------------------+
| SVS Securities plc (Broker) | Phone: +44 207 638 5600 |
| Ian Callaway | |
| | |
+----------------------------------------+----------------------------------------+
| United States contacts: | |
| Grayling, Investor Relations | Phone: +1 646 284 8472 |
| Leslie Wolf-Creutzfeldt | Email: lwolf-creutzfeldt@hfgcg.com |
+----------------------------------------+----------------------------------------+
| | |
| Grayling, Media Relations | Phone: +1 646 284 9455 |
| Ivette Almeida | Email: ialmeida@hfgcg.com |
| | |
+----------------------------------------+----------------------------------------+
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 anemia
* INFRADURE - producing interferon-alpha (IFN-a) to treat Hepatitis-C
The Company's ongoing Phase I/II clinical trial for EPODURE in anemic patients
continues to demonstrate proof of concept of the Biopump. Designed to produce
and deliver a therapeutic dose of EPO steadily for up to six months or more,
EPODURE Biopumps are already maintaining effective anemia treatment for more
than 5 months in earliest patients in the ongoing study, even with low dose
administered.
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.
Medgenics plans to raise the requisite funds during 2009 to enable it to follow
the current trial of EPODURE with a Phase IIb clinical trial in the US starting
in 2010, and in addition, to commence a Phase I/II trial of INFRADURE in
Hepatitis-C patients in Israel also during 2010.
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-ß), hemophilia (Factor VIII), pediatric
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 the London AIM in December 2007 (AIM:
MEDG and AIM: MEDU).
www.medgenics.com
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this release may not occur.
This information is provided by RNS
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