AlloCure Presents Safety and Preliminary Efficacy of AC607 for the Treatment of Acute Kidney Injury at ASN
Phase 1 Trial Results Presented at “Kidney Week 2011”
BURLINGTON, MA (November 14, 2011): New clinical data suggest that a novel therapy
under development by AlloCure may offer the first effective treatment for patients suffering from
acute kidney injury (AKI). In a 16 subject, Phase 1 clinical trial, the AlloCure therapy, AC607,
appeared safe and well tolerated. Furthermore, treated subjects experienced a lower incidence
of AKI, reduced length of hospital stay, and reduced hospital readmission rates compared to a
cohort of historical controls. The study was presented on November 12 at the American Society
of Nephrology annual meeting held in Philadelphia, PA.
“AKI represents a significant unmet medical need and is experienced by approximately 1 million
patients each year in the United States, with profound consequences including extended
hospitalization, the need for dialysis, and death,” said David Warnock, M.D., the Hilda B.
Anderson Endowed Chair in Nephrology at the University of Alabama at Birmingham. “At
present, there are no effective therapies to treat AKI other than supportive measures.”
Robert M. Brenner, M.D., AlloCure President and Chief Executive Officer said, “We are very
encouraged with these initial clinical trial results for AC607 in patients who were at high risk of
AKI, and we look forward to expanding on these results with a Phase 2 trial that is scheduled to
begin in 2012.”
Study Design and Results
The Phase 1 trial of AC607 treated 16 subjects who underwent coronary artery bypass grafting
(CABG) and/or heart valve surgery and who were at high risk for developing AKI. At baseline,
15 subjects had chronic kidney disease, 13 were hypertensive, and 6 had diabetes. The primary
endpoint for the study was safety; none of the study subjects experienced severe adverse
events attributable to AC607 treatment.
To enable a preliminary assessment of efficacy, trial subjects were matched to a cohort of
historical controls from the same institution where the Phase 1 study was conducted. Subjects
were matched according to sex, race/ethnicity, co-morbid conditions, and other risk factors for
AKI. Just 2 of 16 (12.5%) AC607-treated subjects developed AKI (using the Acute Kidney Injury
Network [AKIN] criteria) compared to 19 of 64 (29.7%) of the historical controls. Hospital length
of stay was significantly reduced in the AC607-treated subjects compared to historical controls
[6.5 ± 3.1 days vs. 9.3 ± 5.4 days, respectively (p =0.049)]. Hospital readmission rates were
6.3% vs. 12.5% for AC607-treated subjects and historical controls, respectively. One subject
died within 30 days of surgery in the treated group (unrelated to AC607) vs. 2 in the historical
control group. No subjects in either group received dialysis.
Epidemiological Study of AKI
On November 10 at the ASN annual meeting, AlloCure and OutcomesInsights presented an
epidemiological study of cardiac surgery patients which evaluated different definitions of AKI
and determined the risk of death, dialysis, time to kidney recovery, and duration of hospital stay.
The study analyzed data from 33,249 patients collected from 53 U.S. hospitals. The study found
that patients who developed AKI within 24 hours after surgery were at greater risk of in-hospital
death and dialysis (10.3% and 3.5% respectively), than those who developed AKI between 25 –
48 hours after surgery (5.3% and 2.2% respectively). Across the 24-hour definitions, patients
with a 100% rise in serum creatinine were at the greatest risk for death and dialysis (31.5% and
5.0%, respectively); the number of patients who met this threshold was 1% of the population.
Patients with a 0.5 mg/dL rise (approximately 5% of the total study population) in serum
creatinine within 24 hours of surgery had worse outcomes compared to patients with a 0.3
mg/dL rise within the same timeframe (16.0% death and 6.2% dialysis vs. 10.3% death and
3.5% dialysis, respectively).
Glenn Chertow, M.D., the Norman S. Coplon/Satellite Healthcare Professor of Medicine and
Chief, Division of Nephrology at Stanford University School of Medicine commented that,
”These findings provide new insights regarding the association of clinical outcomes in patients
meeting different definitions of AKI following cardiac surgery. Importantly, these findings can
help to inform the design of prospective clinical trials for the treatment of AKI in this population.”
About AC607
AC607 is a novel biologic therapy under development for AKI and with potential applications in
other grievous illnesses. AC607 is comprised of adult bone marrow-derived mesenchymal stem
cells. AC607 homes to the injured kidney where it mediates an anti-inflammatory, organ repair
process. Importantly, AC607 is not recognized by the immune system, enabling its use in an “off-the-shelf” paradigm without the need for blood or tissue typing.
About AlloCure
AlloCure is a privately held company focused on the treatment of kidney disease. The company
is a leader in the AKI field and is pioneering the development of the first effective therapy for the
treatment of AKI. The company’s headquarters is located in Burlington, MA. For more
information about AlloCure, please visit the company’s web site at http://www.allocure.com.
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© 2013 AlloCure
