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2 Interim Trial Results Cytori Therapeutics (NASDAQ:CYTX)


Cytori Therapeutics is developing treatments of cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, liver and renal disease, and pelvic health conditions. CYTX engages in the development, manufacture, and sale of medical technologies to enable the practice of regenerative medicine. (http://www.cytoritx.com )

Interim RESTORE 2 results presented (12/12/09) demonstrate that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients. These results were based on 6 month follow up from the first 32 women enrolled and treated.   Highlights for the interim results included:

  • A high rate of patient satisfaction (73%) and physician satisfaction (82%) with the overall outcome after a single treatment was reported in difficult to treat breast cancer patients,
  • Mean patient and physician satisfaction scores dramatically – improved – for breast symmetry, scarring and deformity from baseline to 6 month follow-up,
  • Qualitative analysis of imaging data confirmed clinical – improvement – in both breast defect and overall breast shape.

Cytori also reported (12/12/09) results from a preclinical cell-enriched fat grafting study supporting the safety and efficacy of CYTX’s method for enriching fat grafts with ADRCs. The results were presented today at the 32nd Annual CTRC‐AACR San Antonio Breast Cancer Symposium (Poster #4124):

  • The study tracked the expression of important growth factors within the cell-enriched fat grafts and examined the time course of the effect of ADRCs in a transplanted graft and the temporal role of growth factor expression,
  • Results from the pre-clinical cell enriched fat grafting study supporting the safety and efficacy of Cytori’s method for enriching fat grafts with adipose‐derived regenerative cells (ADRCs),
  • The study tracked the expression of important growth factors within the cell‐enriched fat grafts and examined the time course of the effect of ADRCs in a transplanted graft and the temporal role of growth factor expression,
  • The study results demonstrate that the ADRCs used to enrich the fat grafts were active for several days after implantation and secreted several growth factors within the fat grafts. Gene expression for the specific growth factors associated with the restoration and repair of blood vessels was initially very high but subsided to undetectable levels after 3 weeks,
  • The results suggest that the efficacy of the ADRCs may be due in part to their ability to secrete multiple important growth factors locally within the graft. In addition, the subsequent down regulation of these growth factors has positive long‐term safety implications since continued, high level expression of these growth factors may not be desirable,

Bottom Line:  Interim results from a European clinical trial, RESTORE 2, demonstrated that cell-enriched breast reconstruction achieved a high rate of patient and physician satisfaction and improvements in overall breast deformity in lumpectomy patients.

  • RESTORE 2 is a post‐marketing study primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® 800/CRS System. The goal is to support hospital and physician reimbursement and adoption of the Celution® 800/CRS System throughout the EU,

Results from a preclinical cell-enriched fat grafting study supported the safety and efficacy of CYTX’s method for enriching fat grafts with ADRCs.

  • The results suggest that the efficacy of the ADRCs may be due in part to their ability to secrete multiple  growth factors locally within the graft. In addition, the subsequent down regulation of these growth factors has positive long‐term safety implications since continued, high level expression of these growth factors may not be desirable,
  • The initial local secretion of growth factors by ADRCs, followed by the rapid reduction in growth factor levels supports CYTX’s proposed mechanism of action, i.e. the transplanted cells swiftly impart regenerative benefit and then become quiescent.