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Vericel Corporation

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Nick Colangelo, President & CEO, maintained guidance for data from the phase-IIb trial of Ixmyelocel-T for DCM. He stated, "In January, we also announce the completion of patient enrollment in our phase-IIb ixCELL-DCM clinical trial that is evaluating the efficacy in safety of Ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy. By completing enrollment on schedule, we remain on track to report top line results from the study in early 2016."
Source: Q1 2015 earnings conference call, 5/14/15.

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Jan 29, 2015

Vericel Completes Patient Enrollment in Phase 2b ixCELL-DCM Clinical Study of Ixmyelocel-T

CAMBRIDGE, Mass., Jan. 29, 2015 (GLOBE NEWSWIRE) -- Vericel Corporation (Nasdaq:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the completion of patient enrollment in the company's Phase 2b ixCELL-DCM clinical trial evaluating ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM). Top-line results from this study are expected around the end of the first quarter of 2016.

"The ixCELL-DCM study is progressing on schedule and should generate valuable new information about the clinical potential of ixmyelocel-T to treat patients who suffer from advanced heart failure due to ischemic DCM," said David Recker, MD, Vericel's chief medical officer. "We congratulate our clinical investigators on reaching this milestone and thank our study participants, the ixCELL-DCM study steering committee and the independent data and safety monitoring board for their support and commitment to this important research program."
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Source: press release, 1/29/15. http://investors.aastrom.com/releasedetail.cfm?ReleaseID=893593

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April 9, 2014
Aastrom Reports Data and Safety Monitoring Board Recommendation to Continue ixCELL-DCM Clinical Trial

ANN ARBOR, Mich., April 9, 2014 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that the independent Data and Safety Monitoring Board (DSMB) for the company's ixCELL-DCM Phase 2b clinical trial has recommended continuing the study without modification as planned following an interim review of unblinded safety data from the trial.

The ixCELL-DCM clinical trial is a randomized, double-blind, placebo-controlled phase 2b study evaluating ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. More than 30 clinical trial sites are active in the U.S. and Canada and enrollment is expected to be completed in the second half of 2014. The DSMB, which reviews unblinded safety data from the trial on a periodic basis, is comprised of independent third-party experts in cardiovascular medicine, stem cell research and biostatistics.

"We are very pleased with the DSMB's recommendation to continue the ixCELL-DCM clinical trial as planned and appreciate the DSMB's ongoing efforts in overseeing the safety aspects of the study," said David Recker, MD, FACR, FACP, chief medical officer of Aastrom. "We also appreciate the strong commitment of our expert interventional cardiology investigators to this important clinical trial and their continued efforts to complete enrollment of the trial this year."
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Source: press release, 4/09/14. http://investors.aastrom.com/releasedetail.cfm?ReleaseID=839139

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Nick Colangelo, President & CEO, gave guidance for data from the phase-IIb study of ixmyelocel-T in DCM. He stated, "As previously communicated, we expect to enroll the study by the end of Q1 2014 and to have top-line efficacy results from the study in Q2 2015."
Source: Q1 2013 earnings conference call, 5/09/13.

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April 19, 2013

Aastrom Biosciences Announces First Patients Treated in ixCELL-DCM Clinical Study of ixmyelocel-T

ANN ARBOR, Mich., April 19, 2013 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that the first patients were treated in the ixCELL-DCM Phase 2b clinical trial. This study is evaluating the safety and efficacy of ixmyelocel-T compared to placebo in patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM). Aastrom has received U.S. orphan drug designation for the use of ixmyelocel-T in patients with DCM.

"There is an unmet need for additional treatment options for DCM as this condition significantly reduces quality of life and places patients at high risk of multiple hospitalizations and increased mortality. The survival rate for DCM drops to just 30% after five years. Ixmyelocel-T has been shown to promote tissue repair in the heart, which can potentially improve outcomes for the hundreds of thousands of people who suffer from advanced heart failure," said Dr. Safwan Kassas, interventional cardiologist, director of the stem cell and regenerative medicine program at the Michigan CardioVascular Institute/Covenant Medical Center and principal investigator in the ixCELL-DCM trial.

The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure over 12 months.

"We are very enthusiastic about evaluating the therapeutic potential of ixmyelocel-T to treat patients with DCM, and grateful to our study coordinators and investigators for their progress in moving this important clinical program forward," said Nick Colangelo, president and chief executive officer at Aastrom Biosciences.
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Source: press release, 4/19/13. http://investors.aastrom.com/releasedetail.cfm?ReleaseID=757729

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April 4, 2013
Aastrom Biosciences Announces First Patients Enrolled in ixCELL-DCM Phase 2b Clinical Trial of Ixmyelocel-T

ANN ARBOR, Mich., April 4, 2013 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that the first patients have been enrolled in the ixCELL-DCM clinical trial. This Phase 2b study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).

"Enrolling the first patients in the ixCELL-DCM trial is an important milestone in our effort to bring this potential new treatment for advanced heart failure to thousands of people who might benefit from it," said David Recker, M.D., acting chief medical officer at Aastrom Biosciences.

The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months.

"We recently refocused our clinical program on the development of ixmyelocel-T for the treatment of dilated cardiomyopathy and other rare disease indications and are delighted to enroll our first patients in the ixCELL-DCM study," said Nick Colangelo, president and chief executive officer at Aastrom Biosciences. "We have increased the number of sites participating in this study which will help us build momentum in patient enrollment and complete the trial on schedule."

For more information on ischemic DCM and ixmyelocel-T, visit http://www.aastrom.com/cardiovascular-disease-patients/living-with-dcm-v...
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Source: press release, 4/04/13. http://investors.aastrom.com/releasedetail.cfm?ReleaseID=754283

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Timothy M. Mayleben President and CEO, gave guidance for the start and first data from the Ixmyelocel-T for dilated cardiomyopathy program. He stated, "On the DCM program, we are starting a phase IIb, a definitive phase IIb study this quarter. We will have interim data in the third quarter of 2013, so, first data, key inflection point. Second, we will have the 12 month data from the DCM phase IIb study in the first quarter of 2014. Finally, the phase III, the final phase III data from the CLI program in the second half of 2014."
Source: Needham & Company 11th Annual Healthcare Conference, 4/03/12.

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ixCELL DCM - MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TRANSENDOCARDIAL INJECTION OF IXMYELOCEL-T IN SUBJECTS WITH HEART FAILURE DUE TO ISCHEMIC DILATED CARDIOMYOPATHY (IDCM).
Estimated Enrollment: 108
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01670981?term=Ixmyelocel-T&rank=2

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Ixmyelocel-T (2) DCMCardiovascularDilated Cardiomyopathy (DCM)Stem cell placementIschemic cardiac muscle

Mechanism of action: Ixmyelocel-T is a patient-specific, expanded multicellular therapy, manufactured using Aastrom’s proprietary, highly automated, fully closed cell-processing system. The Ixmyelocel-T product consists primarily of autologous CD90+ mesenchymal cells and CD14+ monocytes. These cells are harvested from the patients bone-marrow, expanded in number and then replaced into the patient's damaged tissue.

Phase of Development: IIb

Event Type: Data: Phase IIb trial results

Dates: 2016-01-01 - 2016-03-31

Results:

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Additional Pre-Specified Secondary Results on the Reduction of Ventricular Arrhythmias Presented at AHA from Vericel's Positive Phase 2b ixCELL‑DCM Clinical Trial of Ixmyelocel-T

CAMBRIDGE, Mass., Nov. 14, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of autologous expanded cellular therapies for the treatment of severe diseases and conditions, today announced the presentation of additional pre‑specified secondary endpoint results from the ixCELL-DCM trial at the American Heart Association (AHA) Annual Meeting Scientific Sessions. As previously presented in a late-breaking clinical trial session at the American College of Cardiology's (ACC) 65th Annual Scientific Session, the ixCELL-DCM trial met its primary endpoint with a 37% reduction in the composite endpoint, primarily driven by a reduction in all cause deaths and cardiovascular hospitalizations in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). As previously reported, the composite endpoint was all-cause deaths, cardiovascular hospitalizations, or unplanned outpatient and emergency department visits to treat acute decompensated heart failure. The overall incidence of adverse events, including serious adverse events, was comparable or lower in the ixmyelocel-T than in the placebo group.

In a poster session today at the AHA Scientific Sessions (Abstract 19491), Dr. Tim Henry, director of cardiology at Cedars‑Sinai Heart Institute, presented supportive secondary endpoint data for the ixCELL‑DCM study, a Phase 2b, randomized, double‑blind, placebo‑controlled study in 114 treated patients with advanced heart failure. A pre-specified secondary endpoint included the measurement of ventricular arrhythmia episodes resulting in appropriate shocks or ATP (anti-tachycardia pacing). Ventricular arrhythmias, a form of abnormal heart rhythm that originates in the ventricles of the heart, are associated with sudden death and are common in patients with heart failure and cardiomyopathy (Koplan 2009) At 12 months follow‑up, patients who received ixmyelocel‑T had a 24% reduction in ventricular arrhythmia episodes compared with the placebo group [rate ratio = 0.76; P=0.0502)]. In addition, 8 patients in the placebo group had serious adverse events of ventricular fibrillation compared with 0 patients in the ixmyelocel‑T group. These data suggest that reduction in ventricular arrhythmias may play a role in the clinical benefit observed with ixmyelocel-T multicellular therapy.
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Source: press release, 11/14/16. http://investors.vcel.com/releasedetail.cfm?ReleaseID=999312

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Vericel Announces Positive Top-Line Results From Phase 2b ixCELL-DCM Clinical Trial of Ixmyelocel-T in Patients With Heart Failure Due to Ischemic Dilated Cardiomyopathy
Study Meets Primary Endpoint of Reduction in Clinical Cardiac Events
CAMBRIDGE, Mass., March 10, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced top-line results from the company's Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM). The trial met its primary endpoint of demonstrating a reduction in the total number of deaths, cardiovascular hospitalizations or unplanned outpatient and emergency department visits to treat acute decompensated heart failure during the 12 months following treatment with ixmyelocel-T compared to placebo. All clinical events in the primary and secondary endpoints were adjudicated in a blinded fashion by an independent adjudication committee. The incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to patients in the placebo group. Ixmyelocel-T has been granted orphan product designation by the U.S. Food and Drug Administration for use in the treatment of DCM.

"The results of the ixCELL-DCM study, which we believe is the largest randomized cell therapy trial to treat congestive heart failure completed to date, demonstrated a statistically significant and clinically meaningful reduction in cardiac events in patients who received treatment with ixmyelocel-T compared to placebo," said Dr. David Recker, Vericel's chief medical officer. "We are very excited about these study results given the lack of treatment options for end-stage heart failure patients."

The Phase 2b ixCELL-DCM clinical trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo when administered via transendocardial catheter-based injections to subjects with end-stage heart failure due to ischemic DCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. The trial was designed to provide approximately 80% power to show a 46% difference in cardiac events for ischemic DCM patients treated with ixmyelocel-T compared to placebo. A total of 114 patients were treated in the ixCELL-DCM clinical trial at 28 sites in the United States.

The full data results from the ixCELL-DCM trial are scheduled to be presented at the upcoming Late-Breaking Clinical Trial Sessions of the American College of Cardiology 65th Annual Scientific Session & Expo on April 4, 2016, and also will be submitted for publication.
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Source: press release, 3/10/16. http://investors.vcel.com/releasedetail.cfm?releaseid=959878

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