MISGAV, Israel and SAN FRANCISCO–(BUSINESS WIRE)–Medgenics, Inc., the developer of a novel technology for the
sustained production and delivery of therapeutic proteins in patients using
their own tissue, today announced receipt of clearance from the Israeli
Ministry of Health to initiate a Phase IIa clinical study evaluating the safety
and efficacy of sustained erythropoietin (“EPO”) therapy produced and delivered
by the Companys EPODURE™ Biopumps™. The study will assess EPODUREs ability to
replace months of routine EPO injections for the treatment of anemia in
patients with end-stage renal disease (“ESRD” or “kidney failure”) who are on
dialysis.
EPODURE is an autologous dermal Biopump, a small tissue
implant made from the patients own dermal (skin) tissue, processed to enable
it to continuously produce EPO. EPODURE Biopumps are subsequently implanted
subcutaneously into the patient to provide continuous delivery of EPO.
“Our EPODURE Biopump technology offers potential advantage
over current therapy because it enables patients to continuously produce and
deliver their own EPO within the normal physiological range. Sustained delivery
of EPO is expected to help keep hemoglobin within the target range to reduce
the risks of hemoglobin variability, while avoiding the possible risks posed by
EPO concentrations many times the normal physiological range, as observed with
EPO administrations. EPODURE could potentially be a safer anemia management
tool. Additionally, the cost benefits for the management of anemia could be
highly significant,” said Andrew L. Pearlman, Ph.D., President and Chief
Executive Officer of Medgenics.
This open-label Phase IIa study will enroll up to 20
dialysis patients with anemia due to ESRD who have been receiving routine EPO
injections three times per week. Each patient will receive an individually
targeted initial dose of EPODURE Biopumps designed to produce levels of EPO
that would replace the routine EPO injections over a period of 4-12 months. The
EPODURE dose may be adjusted if needed by adding or removing Biopumps,
emulating the standard care, dose adjustments, currently made with injected
EPO. The studys objective is to maintain hemoglobin levels within the desired
therapeutic range without the need for EPO injections. The study will be
conducted at the Tel
Aviv Sourasky
Medical Center
by principal investigator Doron Schwartz, M.D., Head of the Centers Nephrology
Department. The Ministry of Health has approved the Companys commencement of
the recruitment and treatment of patients, subject to a follow-up safety review
on June 19, 2012, similar to the protocol followed in the Phase I/II
pre-dialysis study.
Dr. Pearlman continued, “We are pleased to have been cleared
to initiate this Phase IIa study in dialysis patients, which we expect will
build on the positive clinical results from our earlier Phase I/II study of
EPODURE to treat pre-dialysis patients with chronic kidney disease. This is the
first clinical study that will permit adjustment of the EPODURE dose based on
patients needs as is currently done in standard EPO treatment, and will be
standard in future EPODURE use. This represents a significant change from the
fixed-dose study we previously conducted in pre-dialysis patients.
“This is the second EPODURE study to be approved by Israels
regulatory agency and will be conducted at the same medical center, with the
same principal investigator as our previous study. We believe this indicates
growing confidence with the EPODURE Biopump in the treatment of anemia, and
supports our clinical strategy. As ESRD patients represent the largest market
segment in renal anemia, we look forward to initiating our first clinical trial
in dialysis patients and are confident that the Phase IIa study results will
affirm the positive data from our study of EPODURE in pre-dialysis patients
demonstrated that a single administration can raise and maintain hemoglobin
levels for many months without any injections of EPO or other erythropoietin
stimulating agents (“ESAs”). In parallel with this new Phase IIa trial in
Israel, we are on track to file an Investigational New Drug application for a
larger Phase IIb trial in the U.S. and, subject to U.S. Food and Drug
Administration approval, look forward to obtaining clearance for that trial
later this year,” concluded Dr. Pearlman.
About Anemia
Anemia is a common complication of renal failure resulting
primarily from insufficient production of the hormone EPO by the damaged
kidneys, which leads to a decrease in production of red blood cells. Treatment
with EPO typically involves intravenous or subcutaneous administration by
injection at regular intervals followed by frequent laboratory tests to monitor
hemoglobin concentration. Due to the short half-life of the protein, it is
usually administered at doses that result in super physiological levels, which
then decline into a more physiologic range. This variability in levels, and in
particular the peak levels, has been hypothesized to potentially increase the
risk of adverse cardiovascular effects and may make maintenance of steady
hemoglobin levels more challenging. The need for frequent injections and
laboratory tests, medication compliance and lifestyle adjustment are potential
barriers to achieving the desired hemoglobin goal. These barriers,
together with the high costs of the currently available recombinant EPO
products, provide an incentive to improve care with a sustained therapy approach.
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 C and
hemophilia. 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™ (now completing a Phase I/II dose-ranging trial) to
produce and deliver erythropoietin for many months from a single
administration, has demonstrated elevation and stabilization of hemoglobin
levels in anemic patients for six to more than 36 months; - INFRADURE™ (planning to commence a Phase I/II trial in Israel in 1H12
in hepatitis C) to produce a sustained therapeutic dose of interferon-alpha for
use in the treatment of hepatitis; - HEMODURE™ is a sustained Factor VIII therapy for the
prophylactic treatment of hemophilia, now in development.
Medgenics intends to develop its innovative products and
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.