San Diego - Cytori Therapeutics (NASDAQ: CYTX) announced today the publication of previously reported six-month outcomes from APOLLO, the Company's European clinical trial evaluating adipose-derived stem and regenerative cells (ADRCs) in patients with acute myocardial infarction (heart attack or AMI), as Research Correspondence in the Journal of the American College of Cardiology. The APOLLO trial was a 14-patient, prospective, randomized, double-blind, placebo-controlled, feasibility trial (Phase I/IIA) evaluating autologous ADRCs extracted with the Company's proprietary Celution® System for the treatment of patients suffering from acute myocardial infarction.
In the APOLLO trial all patients were treated with standard-of-care and subsequently underwent an abdominal liposuction. Each patient's adipose tissue was processed by the Celution® System where ADRCs were extracted, washed and concentrated into a syringe of clinical grade cells. Within 36 hours of the myocardial infarction and no longer than 24 hours after undergoing percutaneous coronary intervention, patients received an injection of either 20 million ADRCs (n=10) or a placebo (n=4).
The publication reported:
- The procedure could be safely performed in an acute setting
- No side effects from ADRC delivery, processed using Celution®
- No increase in arrhythmias
- Improvement in cardiac function by SPECT
- Improvement in blood flow into the heart muscle (perfusion defect)
- Reduction in scar formation (infarct size)
"Based on both the six and 18-month outcomes, which showed continued safety and sustained long-term benefits, we initiated ADVANCE, a pivotal, prospective, randomized, double-blind, European heart attack trial in up to 360 patients," said Christopher J. Calhoun, CEO for Cytori. "The goal of our ADRC therapy is to reduce scarring, preserve heart muscle beyond what can be salvaged with current treatments, minimize harmful remodeling, and ultimately protect patients from advancing into heart failure."
The publication, co-authored by trial investigators Drs. Henricus J. Duckers, Patrick W. Serruys, Jaco H. Houtgraaf at Thoraxcenter, Erasmus University Hospital and others, reported the following:
- The percentage of left ventricle (LV) infarcted was reduced by 52% (31.6 ± 5.3% to 15.3 ± 2.6% at six-month follow-up, p=0.002) in the ADRC-treated patients, as opposed to no change in the placebo-treated AMI patients (24.7 ± 9.2 % vs. 24.7 ± 4.1%). The difference between the groups was not statistically significant.
- There was a significant improvement of the perfusion defect in ADRC-treated patients from 16.9 ± 2.1% to 10.9 ± 2.4% at six-month follow-up (change of 6.0%, p=0.004) as compared to a deterioration in the placebo group by 1.8% (15.0 ± 4.9% to 16.8 ± 4.3%).
- Left ventricular ejection fraction (LVEF), measured by SPECT, improved with an absolute difference of +5.7% (p=0.114). In ADRC treated patients, LVEF improved by 4% (52.1% to 56.1%), as compared to a deterioration of 1.7% in the placebo group (52.0% to 50.3%).
"The advantage of adipose tissue as a cell source is that it allows physicians to get a meaningful dose of a patient's own cells at the point-of-care when using the Celution® System without cell culture or use of donor cells," said Dr. Duckers, lead author of the paper. "We believe delivering cells within the first 24 to 36 hours takes advantage of the body's signaling and initiates the repair process before irreparable damage occurs."
Cytori is currently preparing the full 18 month data set for publication.
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications. Our PureGraft® products are available in North America and Europe for fat grafting procedures. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends, business prospects and particularly relating to mechanisms and effectiveness of our ADRC therapy and our APOLLO and ADVANCE clinical trial, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding improvements in patient outcomes, the significance of the physiological and functional effects from the pilot APOLLO trial, and the mechanisms and effectiveness of the design of the ADVANCE trial, are all subject to risks and uncertainties that could cause the results of the more comprehensive ADVANCE trial to differ materially from those presented above. Some of these risks and uncertainties include, but are not limited to, risks related to the statistical power of the APOLLO trial, the inherent risk and uncertainty in the costs and potential variability of outcomes of a pivotal heart attack trial, uncertainties regarding the collection and results of clinical data, and dependence on third party performance, as well as other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.