MEDG Medgenics(Regs)

 

TIDMMEDG 
 
 
Medgenics Inc 
15 April 2010 
 
 
For release: 15 April 2010 
 
 
SUSTAINED INTERFERON ALFA-2b (IFNa) PRODUCTION IN VITRO AND DELIVERY IN VIVO BY 
   MEDGENICS DERMAL MICROORGAN BIOPUMPS SHOWCASED AT THE MAJOR EUROPEAN LIVER 
                                MEETING IN VIENNA 
 
Interferons have been shown to be effective treatment for chronic hepatitis C 
but their use has been associated with frequent side effects.  Current treatment 
involves administration of peginterferon alpha injections weekly for 6 to 12 
months. These injections generate high peak levels of interferon alpha (IFNa), 
which give rise to side effects, cause patient discomfort and lead some patients 
to discontinue treatment. The provision of consistent therapeutic levels of IFNa 
over a prolonged period of time could substantially reduce the side effect 
profile and improve the treatment of chronic hepatitis C, a disease that affects 
approximately 170 million people around the world. 
 
Medgenics, Inc. has a unique platform technology that creates dermis-based 
micro-organs, called Biopumps, capable of producing therapeutic proteins.  A 
needle biopsy taken from a patient's own skin is used to prepare the Biopump. 
Medgenics has produced more than 5000 Biopumps, all of which have shown the 
capability for the sustained production of therapeutic proteins such as 
erythropoietin (EPO), IFNa, and others.  In previous clinical studies, the 
Company has reported that a single administration of a few Biopumps producing 
the protein EPO has provided effective sustained treatment of anemia for more 
than a year.  Patients with chronic kidney disease have been treated for periods 
of 6 to 16 months, without the need for additional EPO injections. 
 
On April 15th at the 2010 European Association for the Study of Liver Diseases 
(EASL) conference, Medgenics is presenting findings from key preclinical studies 
of Biopumps that produce IFNa intended for use in the treatment of chronic 
hepatitis C.  In the two posters being presented, Medgenics reports (1) the 
reliable sustained production by Biopumps of potent human IFNain vitro, and (2) 
the in vivo production and delivery of human IFNa in SCID mice following the 
implantation of such Biopumps, called INFRADURE.  In anticipated clinical use, 
as with the anemia clinical trial, each patient would receive the requisite 
number of INFRADURE Biopumps intended to provide their recommended daily IFNa 
dose.  Dose levels can be increased by administering additional Biopumps, or 
reduced at any time by ablating one or more of Biopumps already administered. 
 
Key points arising from these posters are: 
 
To be commercially viable, IFNa Biopumps should each produce a target of > 1 
µg/day of IFNa in vitro.  The data presented in these posters showed that 
INFRADURE Biopumps provide sustained IFNa production at or exceeding 1-2 µg/day 
for at least 129 days in vitro. 
 
INFRADURE Biopumps produced from the skin of 7 patients, tested in vitro, all 
met the target potency criteria, despite moderate variability in the levels 
reached between patients' skin samples. 
 
Data are presented that show Biopumps manufactured from skin samples of the same 
patient producing different proteins: EPO and IFNa.  This demonstrates the 
concept that the Biopump is a platform technology that has the potential for 
administration of a wide range of therapeutic proteins. 
 
Dose-dependent delivery and non-toxicity were demonstrated by in vivo studies in 
mice using INFRADURE Biopumps producing an IFNa dose appropriate for 70 kg 
humans. Two doses were administered: (1.3 µg/day and  4,0 µg/day,  the "lower" 
and "higher" doses respectively were implanted into 20 g SCID mice. 
 
Dose response was seen on day 10 post-implantation: the "lower" group averaged 
1700 pg/ml, and the "higher" group averaged 8,900 pg/ml.   During the 3-4 months 
thereafter, the initially high levels of IFNa in mice were reduced to normal 
therapeutic levels in the10 pg/ml range.  Serum levels of the "higher" dose 
animals were always greater than those of "lower" dose animals, and were well 
tolerated even though both doses greatly exceeded those that are used 
clinically.  Necropsy revealed no abnormalities, indicating that even these 
large doses of IFNa from INFRADURE Biopumps were well tolerated. 
 
These findings parallel those found with EPODURE Biopumps tested under similar 
circumstances in vitro and in SCID mice. 
 
Based on the data reported at the EASL 2010 conference, Medgenics believes 
sustained IFNa treatment for chronic hepatitis C should be achievable by 
administering INFRADURE Biopumps to typical hepatitis C patients, in like manner 
to the results reported for EPODURE in treatment of anemia.  Medgenics hopes to 
bring INFRADURE to clinical trials in the near future. 
 
Medgenics believes Biopumps will provide a potentially improved approach to 
therapy with fewer side effects and is likely to provide a more cost-effective 
treatment for hepatitis C and other chronic diseases.  Biopumps represent an 
example of personalized medicine as the treatment is unique to the patient. 
 
Commenting on the data being presented, Professor Bruce R. Bacon, past president 
of the American Association for the Study of Liver Diseases said "The 
development of this novel Biopump technology provides the potential for an 
improved method for safe, effective interferon delivery that is cost-effective 
and efficacious." 
 
If you would like a copy of the posters and comparative data for EPODURE, please 
contact: Anna Dunphy (a.dunphy@defacto.com) or Mike Wort (m.wort@defacto.com). 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
 NRASFUSAIFSSELL 
 

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