AlloCure’s Investigational Treatment for Acute Kidney Injury Receives Fast
Track Designation by FDA
BURLINGTON, MA (January 5,
2012):
AlloCure, Inc., a clinical stage biotechnology company
focused on the treatment of kidney disease, today announced that the U.S. Food
and Drug Administration (FDA) has granted Fast Track designation to AC607, the
company’s investigational treatment for acute kidney injury (AKI).
The FDA’s Fast Track program is designed to facilitate development and expedite
the review of new therapeutics that are intended to treat serious or
life-threatening conditions and that demonstrate the potential to address unmet
medical needs.
“The positive results from our Phase 1 trial of AC607, which showed an excellent
safety profile and suggested an ability to reduce both the incidence of AKI and
hospital length of stay in cardiac surgery patients, demonstrate the potential
of this novel therapy to offer the first effective treatment for AKI,” said
Robert M. Brenner, M.D., AlloCure President and Chief Executive Officer. “The
Fast Track designation recognizes the unmet and high therapeutic need in AKI,
which can result in extended hospitalization, the need for dialysis, and death.”
About AC607
AC607 is a novel biologic therapy under development for
the treatment of AKI that also possesses potential applications in other
grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal
stem cells that are harvested from healthy adult donors and then expanded via a
mature and state-of-the art manufacturing process. AC607 homes to the site of
injury where it mediates anti-inflammatory and organ repair processes via the
secretion of beneficial paracrine factors, without differentiation and
repopulation of the injured kidney. Importantly, AC607 avoids recognition by the
immune system, enabling administration in an “off-the-shelf” paradigm without
the need for blood or tissue typing. Following the completion of a successful
Phase 1 trial, which was presented in November 2011 at the annual meeting of the
American Society of Nephrology, AlloCure plans to initiate a Phase 2 study of
AC607 in the first half of 2012.
About AlloCure
AlloCure, Inc. 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
company’s web site at http://www.allocure.com.
Contacts:
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.
Contacts:
AlloCure Appoints Kevin J. Heyeck as Chief Business Officer
Burlington, Massachusetts (February 14, 2011): AlloCure Inc., a biotechnology company developing innovative therapies for the treatment of kidney disease, today announced the appointment of Kevin J. Heyeck as Chief Business Officer. Mr. Heyeck, who brings more than twenty years of experience in business development leadership and corporate partnering for emerging pharmaceutical companies, previously led business development efforts at Vitae Pharmaceuticals, and before that, Pharmacopeia.
“Kevin Heyeck has a very impressive track record in business development, and he has been responsible for many major partnerships with large pharmaceutical and biotechnology companies worldwide,” said Robert M. Brenner, M.D., AlloCure’s President and Chief Executive Officer. “We are delighted to welcome Kevin to the AlloCure management team. Kevin’s arrival marks an important milestone in AlloCure’s evolution as we advance into later stage clinical development and chart the course for future commercialization of our novel treatment for acute kidney injury.”
“Kidney disease is a significant social and economic societal burden. Approximately 2-3 million people in the United States experience acute kidney injury (AKI) each year, which contributes to chronic kidney disease, end-stage renal disease (ESRD), and too often, death,” said Mr. Heyeck. “The lack of therapies to prevent and treat AKI makes this condition a critical area of unmet medical need. AlloCure has made great strides in advancing its investigational treatment for AKI towards clinical proof-of-concept, and I look forward to working with the talented team at AlloCure to realize the promise of this new therapeutic approach for patients in need.”
Prior to joining AlloCure, Kevin Heyeck was Vice President, Business Development at Vitae Pharmaceuticals where he was responsible for securing multiple major partnerships in areas of Alzheimer’s disease, diabetes and hypertension. Prior to Vitae, Mr. Heyeck headed business development for Pharmacopeia, a pioneer in the use of combinatorial chemistry in drug discovery, where he was responsible for over 20 partnerships with pharmaceutical and biotechnology companies worldwide. Prior to Pharmacopeia, Mr. Heyeck was Technology Transfer Officer at Harvard University. He received his B.A. degree at the University of California, Santa Cruz.
About Acute Kidney Injury and Chronic Kidney Disease
Acute kidney injury (AKI) is a serious medical condition and is associated with considerable morbidity, mortality and healthcare costs. There are currently no effective treatment options to prevent or treat AKI, other than supportive measures, including dialysis. Acute kidney injury can lead to a progression of chronic kidney disease, ESRD, and death. Twenty-three million Americans suffer from chronic kidney disease, 500 thousand of whom have ESRD. Kidney disease and its complications account for approximately 20% of the annual Medicare budget.
About AlloCure
AlloCure is a privately held, venture-funded company focused on the treatment of kidney disease. The company has made great progress in the development of the first effective cell therapy for the treatment of kidney diseases as well as other unmet medical needs. The company’s headquarters is located in Burlington, MA, and the company maintains facilities in Salt Lake City, UT. For more information about AlloCure, please visit the company’s web site at http://www.allocure.com.
Contacts:
AlloCure Names Robert M. Brenner, M.D. Chief Executive Officer
- AlloCure in clinical development with allogeneic mesenchymal stem cell therapy for kidney disease
- Establishing new corporate headquarters in Burlington, MA
Burlington, Massachusetts (July 6, 2010): AlloCure Inc., a biotechnology company pioneering the use of cell therapies for the treatment of kidney diseases, today announced the appointment of Robert M. Brenner, M.D., as President and Chief Executive Officer. Dr. Brenner, who brings extensive clinical development and medical affairs expertise in the field of nephrology, was previously Senior Vice President of Medical Affairs at AMAG Pharmaceuticals and for nine years made leading contributions to Amgen’s global development efforts in nephrology and renal anemia. John Wirthlin, AlloCure’s prior CEO, assumes the position of Chief Operating Officer and remains a member of the company’s management team.
"Robert Brenner’s extensive medical background, relationships with the nephrology community, and experience with the strategic development and commercialization of important renal therapeutics will be a major asset for AlloCure as the company advances its novel cell therapy through the clinic and towards commercialization," said Lutz Giebel, Ph.D., AlloCure board member and Managing Partner, SV Life Sciences.
"With the expansion of the company’s activities in preparation for Phase 2 clinical trials, we are pleased that John Wirthlin will serve as COO, working closely with Rob on the company’s management team," said Thomas Dyrberg, Senior Partner, Novo Ventures, Novo A/S.
"AlloCure has made great strides in advancing the promise of cell therapy for the preservation of kidney health,” said Robert M. Brenner, M.D." I am excited to join the company in this dynamic period and am eager to contribute to fully developing this therapy for the benefit of patients so greatly in need."
Preparing for Phase 2 Trials in Acute Kidney Injury
"AlloCure has reached an important milestone in the company’s evolution, with the completion of enrollment in our Phase 1 trial in acute kidney injury," said John Wirthlin. "We look forward to completing this study soon and presenting the results in an appropriate scientific forum. We are now preparing for a Phase 2 study aimed at providing clinical proof-of-concept for our technology."
Robert M. Brenner, M.D. Biography
Robert M. Brenner, M.D. joins AlloCure from AMAG Pharmaceuticals, where he was Senior Vice President of Medical Affairs and responsible for the company’s nephrology clinical development activities. Previously, Dr. Brenner was at Amgen for nine years where he served in a variety of nephrology leadership roles both in clinical development and medical affairs, ultimately holding the title of Executive Director and Renal Anemia Global Program Area Leader. During his career, Dr. Brenner contributed to the approval of new products, led the design of clinical trials, and was a key liaison to the nephrology community, professional societies and regulatory agencies.
Dr. Brenner received his B.A. from Johns Hopkins University and his M.D. from Albert Einstein College of Medicine. He completed his medical residency in internal medicine at Brigham and Women's Hospital in Boston and his fellowship in nephrology at Stanford University Medical Center.
About Acute Kidney Injury
Acute kidney injury (AKI) is a serious medical condition and is associated with considerable morbidity, mortality and healthcare costs. There are currently no effective treatment options to prevent or treat AKI, other than supportive measures, including dialysis. AlloCure’s innovative cell therapy offers the promise of improving outcomes in patients afflicted with this serious condition.
About AlloCure
The scientists of AlloCure, founded in 2008 and previously known as NephroGen, have made great progress in the development of the first effective cell therapy for the treatment of kidney diseases as well as other unmet medical needs. AlloCure has developed proprietary and highly efficient protocols for the harvesting, expansion, and functional characterization of bone marrow-derived human Mesenchymal Stem Cells (MSC), also termed Multipotent Stromal Cells. These AlloCure protocols were used to prepare the allogeneic MSCs (no matching of donor and recipient tissues required, permitting off-the-shelf use) that were tested in the phase I clinical trial for acute kidney injury. The design of the trial was based on extensive pre-clinical studies conducted at AlloCure's laboratory in Salt Lake City, Utah. This work established the protective activity of MSCs in experimental acute kidney injury, and identified the critical mechanisms whereby these cells both protect and stimulate the repair and return of function of an injured kidney or other organ. The Salt Lake City laboratory continues to pursue important investigations in support of the therapeutic application of these unique MSCs.
AlloCure, a privately held, venture-funded company, raised a $14.5 million Series A financing from SV Life sciences and Novo A/S in July 2008. The company's headquarters is located in Burlington, MA, with another location in Salt Lake City, UT.
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© 2012 AlloCure
