First Subjects Enrolled in Phase IIa Clinical Trial of EPODURE Biopumps to Treat Anemia in Patients with End-Stage Renal Dise...
July 17 2012 - 9:30AM
Business Wire
Medgenics, Inc. (NYSE MKT: MDGN and AIM: MEDU, MEDG), the
developer of Biopump™, a novel technology for the sustained
production and delivery of therapeutic proteins in patients using
their own tissue, announces the launch of its Phase IIa clinical
trial in Israel of EPODURE™ Biopumps to treat anemia in patients
with end-stage renal disease (“ESRD” or “kidney failure”) on
dialysis, through the sustained delivery of erythropoietin (“EPO”).
Following the Israeli Ministry of Health’s recent approval of the
trial, Medgenics has enrolled and begun to treat the first two
dialysis patients ever to receive EPODURE Biopumps.
Enrollment is expected to continue in the coming months, with up
to 20 patients being treated with EPODURE Biopumps. The study will
evaluate the ability of EPODURE Biopumps to replace most or all of
the injections of EPO or other erythropoietic stimulating agents
(“ESAs”) currently used in standard care, while maintaining the
patient’s blood hemoglobin level within the desired range. The
current standard of care involves years of frequent EPO or ESA
injections, which require patient compliance to reliably administer
the drug during that time. Each injection is short-lived, typically
causing extreme transient elevation of EPO in the patients’ blood,
followed by decline to ineffective levels within a few days, so the
patient is not receiving sufficient drug until the next injection.
The high transient levels of EPO in the blood are a source of
safety concern to the U.S. Food and Drug Administration (“FDA”) as
well as to many medical experts.
Medgenics’ EPODURE Biopumps aim to provide a cost effective way
to maintain hemoglobin within a target physiological range for
these patients through the sustained delivery of EPO, which avoid
the extreme elevations seen with injection. Medgenics believes that
this steady delivery could improve the safety and efficacy of
anemia treatments while enhancing patient quality of life by
providing a more reliable treatment that reduces or eliminates the
need for frequent EPO or ESA injections, while also providing
significant cost benefits to payers.
In a prior Phase I/Phase II study with EPODURE Biopumps,
Medgenics treated pre-dialysis patients with chronic kidney
disease. That study, which only allowed for a single fixed dose to
each patient, showed that a single administration of EPODURE
Biopumps successfully raised or maintained hemoglobin in the
therapeutic range for six to 36 months without the need for EPO or
ESA injections, while serum EPO levels remained within normal
range. This latest Phase IIa study allows for an adjustment of the
initial dose based on the patient’s response to the prior EPO
injections, which the administration of EPODURE Biopumps aims to
replace for many months at a time.
For the first two patients in the current study, the EPODURE
procedure has gone well, as in the previous study, and EPO
concentrations were confirmed to be elevated within normal range in
the patients’ blood in the days following EPODURE administration.
This is consistent with the Phase I/Phase II findings, which
indicated that EPODURE Biopumps were delivering EPO in the
patients. Moving forward, patients will be followed to determine
how long their hemoglobin levels remain in the desired range while
EPO levels remain within normal range.
“Our planned Phase II studies will provide valuable insight into
extending the use of EPODURE from treating anemia in pre-dialysis
patients to treating the anemia of dialysis patients – the largest
segment of the anemia market. Although it is very early, we are
pleased to see that EPODURE is performing similarly in dialysis
patients as it did in pre-dialysis patients, providing us further
confidence in EPODURE and in the Biopump platform. While we
continue our Phase IIa study in Israel, we are preparing for the
launch of the larger, Phase IIb study in dialysis patients in the
U.S. before the end of this year. Once completed, we believe that
these studies will provide data to support the use of EPODURE in
the treatment of anemia from chronic kidney disease,” stated Andrew
L. Pearlman, Ph.D., President and Chief Executive Officer of
Medgenics.
About Medgenics
Medgenics is developing and commercializing Biopump™, a
proprietary tissue-based platform technology for the sustained
production and delivery of therapeutic proteins using the patient's
own skin biopsy for the treatment of a range of chronic diseases
including anemia, hepatitis, and hemophilia, among others.
Medgenics believes this approach has multiple benefits compared
with current treatments, which include regular and costly
injections of therapeutic proteins.
Medgenics has three long-acting protein therapy products in
development based on this technology:
- EPODURE™ to produce and deliver
erythropoietin for many months from a single administration, which
has demonstrated elevation and stabilization of hemoglobin levels
in anemic patients for periods of six months to more than 36 months
in a Phase I/II dose-ranging trial in Israel and has launched a
Phase IIa trial in dialysis patients in Israel. An Investigational
New Drug application has been cleared by the FDA to initiate a
Phase IIb study to evaluate the safety and efficacy of EPODURE in
the treatment of anemia in dialysis patients in the U.S.
- INFRADURE™ for sustained production and
delivery of interferon-alpha for use in the treatment of hepatitis
is awaiting final approval of the Israeli Ministry of Health of two
Phase I/II trials in Israel in hepatitis C, slated to commence Q3
2012; and which received Orphan Drug Designation from the FDA for
the treatment of hepatitis D.
- HEMODURE™ for sustained production and
delivery of clotting Factor VIII therapy for the sustained
prophylactic treatment of hemophilia is now in development.
Medgenics is focused on the development and manufacturing of its
innovative Biopumps, aiming to bring them to market via strategic
partnerships with major pharmaceutical and/or medical device
companies.
In addition to treatments for anemia, hepatitis and hemophilia,
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 $132 billion in
2013. Other potential applications for Biopumps include multiple
sclerosis, arthritis, pediatric growth hormone deficiency, obesity
and diabetes.
Forward-looking Statements
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of the Securities Exchange Act of 1934 and as that term is defined
in the Private Securities Litigation Reform Act of 1995, which
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including (without limitation) those regarding the Company's
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product candidates and the plans and objectives of management for
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forward-looking statements contained in this release may not
occur.
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