- Separate Studies Distinguish Safety and Viability of Cytori’s Cell Therapy from Alternate Approaches -
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ:CYTX) announced that three oral presentations related to its cell therapy are being presented today at the 10th annual International Federation for Adipose Therapeutics and Sciences meeting. The findings provide insights into the mechanisms-of-action for Cytori’s cell therapy. One study identified high levels of micro-RNA (miRNA) markers in human tissue thought to play a role in the repair of tissue injury resulting from ischemia, or lack of blood flow. Two additional characterization and comparative analysis studies on human tissue reaffirmed cellular characteristics of Cytori’s cell therapy and distinguished the safety, viability and cell make-up as compared to cell outputs derived from alternate approaches.
“Results from all three studies have important implications for how the cells repair injured tissue and on the safety and viability of cell-based treatments derived from adipose tissue,” said John Fraser, Ph.D., Chief Scientist of Cytori Therapeutics. “Mechanisms identified in our miRNA analysis are consistent with our prior clinical and preclinical data, which suggest these mechanisms include angiogenesis, immune-modulation, and remodeling and wound repair. The miRNA study provides baseline data, which we can apply to our U.S. ATHENA clinical trial in refractory heart failure patients and other activities including our recently announced contract with BARDA for thermal burns.”
In one study, miRNA profiles were assessed in adipose-derived stem and regenerative cells (ADRCs) derived from human tissue samples. The purpose was to determine which miRNA markers are expressed, miRNA variability from patient to patient, cellular functions of miRNA, and to establish a baseline miRNA population on healthy patients to compare against patients with a specific disease. Specifically, miRNA markers associated with angiogenesis, tissue remodeling and wound repair, and modulation of the immune response were found to be highly represented in ADRCs.
“Our two additional characterization and comparative analysis studies evaluated alternate processing techniques and reaffirmed our proprietary enzyme-based process using Celution® is the clear gold standard,” added Dr. Fraser. “If the composition of a cell population extracted from adipose tissue by an alternative process is not equivalent to Cytori’s ADRC population, one cannot claim equivalence to ADRCs in terms of safety or efficacy in preclinical or clinical outcomes.”
The characterization and comparative analysis studies reaffirmed the high cell yield and viability as well as the heterogeneity in Cytori’s cell therapy approach. Cytori’s cells are derived with a proprietary formulation of clinical grade enzymes which break up the connective tissue and which are removed at the end of the process. Cytori’s cell mixture includes adipose-derived stem cells, based on the measure of colony forming units, and a high yield of CD34+ cells. By contrast, data in these studies showed that alternate approaches such as ultrasound or emulsification, contained little to no adipose-derived stem cells, a high concentration of red and white blood cells, and did not meet the key criteria for safe clinical use.
Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution® system product family. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements including our ability to apply this data to our ATHENA study and other projects are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2011. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.
The Celution® System is available in the United States for investigational use only.
Source: Cytori Therapeutics