Cesca Therapeutics Announces Promising Results From 40-Month Follow-Up of Patients Enrolled in Critical Limb Ischemia Feasibility Study
Rancho Cordova, Calif. / CRWE PRESS RELEASE / August 03, 2016 - Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced 40-month follow-up results for a number of patients that participated in the Company’s earlier feasibility study using Cesca’s proprietary SurgWerks™ system for the treatment of late stage, “no option” critical limb ischemia (CLI).
The feasibility study was conducted in 2011 at Fortis Escorts Heart Institute in New Delhi, India, where seventeen patients with late stage CLI, all of whom had exhausted available surgical options short of a major limb amputation, were treated with autologous bone marrow derived stem cells. The 40-month follow-up was approved as a protocol amendment by the local Institutional Ethics Committee, specifically to measure longer-term safety and efficacy end-points related to limb salvage, disease progression, and quality of life improvement.
Results from the original study reported successful limb salvage for twelve of the seventeen patients after twelve months. In the 40-month follow-up, three of the 12 patients that were amputation-free at 12 months could not be contacted, but the remaining nine were clinically assessed. The results reported favorable clinical outcomes, including a significant overall reduction in rest pain and improvements in quality of life. All nine patients still had their limbs and exhibited no sign of disease progression, though two of the nine had in the interim undergone additional SurgWerks treatments to relieve mild to moderate rest pain. There were no adverse or serious adverse events reported at the 40 month follow-up, and there were no safety concerns attributed to the treatment procedure.
"These longer-term, post-study follow-up results not only reinforce our belief that autologous bone marrow derived stem cell therapy using our SurgWerks-CLI system is effective, they also suggest that it is durable”, said Dr. Venkatesh Ponemone, Study Director and Executive Director of TotipotentRX, a subsidiary of Cesca Therapeutics Inc. “We look forward to starting the Phase III pivotal clinical trial recently approved by the FDA and to ultimately making the SurgWerks-CLI procedure available to patients,” he added.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. These include:
- The SurgWerks™ System (in development) - a proprietary system comprised of the SurgWerks Processing Platform, including devices and analytics, and indication-specific SurgWerks Procedure Kits for use in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.
- The CellWerks™ System (in development) - a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
- The AutoXpress® System (AXP®) - a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
- The MarrowXpress™ System (MXP™) - a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
- The BioArchive® System - an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
- Manual bag sets for use in the processing and cryogenic storage of cord blood.
Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release includes statements of future expectations and other forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change. Forward-looking statements can often be identified by words such as “may,” “could,” “potential,” “continue,” “belief,” “suggest,” “look forward to” and similar expressions and include, but are not limited to, statements regarding research and product commercialization, our belief concerning the efficacy and durability of our SurgWerks-CLI procedure, the start, if at all, of the Phase III pivotal clinical trial for SurgWerks-CLI, and the ultimate commercial availability of the procedure to patients. These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption "Risk Factors" in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.
Cesca Therapeutics Inc.
Source: Cesca Therapeutics Inc.