FRAZER, Pennsylvania and
MELBOURNE, Australia, January 10, 2011 /PRNewswire/ -- Cephalon, Inc.
(Nasdaq: CEPH) and Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY)
today announced positive interim results from Mesoblast's ongoing
multi-center Phase 2 trial of its "off-the-shelf" proprietary adult
stem cell product Revascor(TM) for patients with congestive heart
failure. Patients who received a single injection of Revascor(TM)
into damaged heart muscle have had less cardiac events, deaths, and
hospitalizations during the follow-up period to date than control
patients.
Cephalon and Mesoblast have entered into a strategic alliance to
develop and commercialize Mesoblast's Mesenchymal Precursor Cell
(MPC) therapeutics for hematopoietic stem cell transplantation in
cancer patients, as well as degenerative conditions of the central
nervous and cardiovascular systems, including congestive heart
failure.
Mesoblast is evaluating the safety and efficacy of Revascor(TM)
in a randomized, placebo-controlled Phase 2 trial in 60 patients
with moderate-severe congestive heart failure. A single injection
of Revascor(TM) at one of three progressively increasing doses has
been administered to 45 patients randomized to receive cell therapy
in addition to standard-of-care, while 15 control patients have
been concomitantly randomized to receive standard-of-care alone.
The trial will be completed when all available patients have been
followed-up for 12 months.
A scheduled interim analysis of safety and of time-dependent
hard efficacy endpoints was performed when the last of the 60
enrolled patients had completed six months of follow-up in
December 2010. At this time point,
the 45 patients who received Revascor(TM) had been followed for a
mean of 18.5 months/patient and the 15 controls had been followed
for a mean of 18 months/patient.
There have been no cell-related adverse events in any of the 45
patients treated with Revascor(TM), demonstrating that all three
doses of the cell therapy product are safe over both the short and
medium term.
Analyses of time-dependent hard efficacy endpoints showed that a
single injection of Revascor(TM) significantly reduced the number
of patients who developed any severe adverse cardiac events over
the follow-up period from 93.3% in the control group to 44.4% in
the treated patients (p=0.001). Revascor(TM) also significantly
reduced the number of patients who developed any major adverse
cardiac events (MACE, defined as the composite of cardiac death,
heart attack, or coronary revascularization procedures) from 40% to
6.7% (p=0.005). A single injection of Revascor(TM) reduced the
overall monthly event rate of a MACE by 84% compared with controls
(p=0.01), and every dose tested demonstrated a similar protective
effect. Death from cardiac causes was reduced from 13.3% to 0% over
this period (p=0.059) and the overall monthly rate of
cardiac-related hospitalizations was reduced by 48% (p=0.07).
Mesoblast CEO Professor Silviu
Itescu said: "We are very pleased with these interim results
that show for the first time that our proprietary technology can
impact both quality of life and survival. If these long-term
beneficial outcomes from a single dose of our adult stem cells are
sustained they will translate into significant improvements to the
quality of life and longevity of patients who are struggling with
debilitating congestive heart failure".
Cephalon CEO J. Kevin Buchi said:
"These results underscore Cephalon's strong belief in the value of
our strategic investment in Mesoblast's innovative adult stem cell
technology platform. We shall now look to progress clinical
development of Revascor(TM) for the treatment of congestive heart
failure towards a Phase 3/pivotal trial."
Mesoblast plans to present the complete trial results at an
appropriate cardiology conference.
About Heart Failure
Congestive heart failure remains a leading cause of hospital
admissions, morbidity and mortality in the Western world. The
American Heart Association and the National Heart, Lung, and Blood
Institute have estimated that cardiovascular disease and stroke
cost the United States at least
US$448.5 billion annually, and the
burden continues to grow as the population ages. In the United States alone, congestive heart
failure has an annual incidence of 670,000 patients, a prevalence
of 6.2 million patients, and causes over 1.1 million
hospitalizations and 300,000 deaths per year. Heart failure affects
around 10 million in Europe and as
many as 20 million worldwide.
About Revascor
Revascor(TM) is an allogeneic cell therapy product being
developed to reverse congestive heart failure by rebuilding both
blood vessels and heart muscle. Revascor(TM) is delivered to
damaged areas of the heart by a minimally invasive cardiac
catheterization procedure performed under local anaesthesia while
the patient is awake. Patients undergoing the procedure are usually
released from the hospital within 24 hours.
About Mesoblast Limited
Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) is a world leader
in the development, manufacture, and commercialization of biologic
products for the broad field of regenerative medicine. Mesoblast
has the worldwide exclusive rights to a series of patents and
technologies developed over more than 10 years relating to the
identification, extraction, culture and uses of adult Mesenchymal
Precursor Cells (MPCs). More information -
http://www.mesoblast.com
About Cephalon, Inc.
Cephalon is a global biopharmaceutical company dedicated to
discovering, developing and bringing to market medications to
improve the quality of life of individuals around the world. Since
its inception in 1987, Cephalon has brought first-in-class and
best-in-class medicines to patients in several therapeutic areas.
Cephalon has the distinction of being one of the world's
fastest-growing biopharmaceutical companies, now among the Fortune
1000 and a member of the S&P 500 Index, employing approximately
4,000 people worldwide. The company sells numerous branded and
generic products around the world. In total, Cephalon sells more
than 150 products in nearly 100 countries. More information on
Cephalon and its products is available at
http://www.cephalon.com/
Media contacts
Cephalon:
Fritz Bittenbender
Vice President, Public Affairs
T: +1-610-883-5855
C: +1-610-457-7041
Fbittenb@cephalon.com
Natalie de Vane
Sr. Director, Corporate Communications & Public Affairs
T: +1-610-727-6536
C: 48-319-3722
ndevane@cephalon.com
Mesoblast:
Julie Meldrum
Vice President, Corporate Communications
T: +61-(3)-9639-6036
C: +61-(419)-228-128
julie.meldrum@mesoblast.com
