Results from RECOVER-Stroke Phase 2 Trial Show No Significant Clinical Benefit; Completion of R&D Restructuring Expected to Lead to Additional Cost Savings
Continued Strategic Focus on AutoloGelTM Launch and Building Profitable Wound Care Busines
GAITHERSBURG, MD, USA I May 5, 2014 I Cytomedix, Inc. (OTCQX: CMXI), a leading developer of biologically active regenerative therapies, and its wholly owned subsidiary, Aldagen, Inc., announced today the preliminary efficacy and safety results at 90 days from the RECOVER-Stroke phase 2 study in patients with neurological damage arising from an ischemic stroke and treated with ALD-401. Observed improvements in the primary endpoint (mean modified Rankin Score or mRS) were not clinically or statistically significant. In light of this outcome, Cytomedix plans to discontinue further funding of the ALDH Bright Cell development program and close its R&D Facility in Durham, NC. The Company remains focused on its commercial launch initiative for AutoloGelTM with the goal of driving sales in the estimated $3.4 billion U.S. chronic wound market.
“Ischemic stroke is a challenging medical condition with no effective therapeutic products available to help,” said Martin Rosendale, CEO of Cytomedix. “While the observed benefit of ALD-401 in the RECOVER-Stroke trial is disappointing, the ongoing NIH-funded PACE study in patients with peripheral artery disease (PAD) is approximately 30% enrolled and is continuing at a good rate. PAD is a serious medical problem affecting approximately 8 million people in the U.S., and can lead to chronic wounds, amputation, and death.
With the NIH supporting the PACE study, we believe that the planned closure of our Durham facility is a necessary strategic decision for the Company. The elimination of the associated R&D expense will further reduce our cash burn and is in line with our previously announced goal of building a more commercially focused company.”
Results from Phase 2 RECOVER-Stroke Trial and R&D Reorganization
The study results for patients followed 90 days post treatment with ALD 401 include:
· Group mean and categorical change differences in mean modified Rankin Score (mRS) were not different between the ALD-401 and sham treatment groups
· Secondary endpoints were not different between groups
· The safety findings at 90 days are consistent with past reviews by the Data Safety Monitoring Board. There have been no serious adverse events attributable to the use of ALD-401, demonstrating good tolerability and safety.
All patients will be followed for one year, and complete efficacy and safety data will be provided to the scientific community.
In light of the foregoing, Cytomedix plans to close its R&D facility in Durham, NC in May 2014. This decision is consistent with the Company’s ongoing realignment of its commercial operations to focus on the wound care market and is expected to result in annual savings of approximately $4 million.
PACE Study with ALD-301 in Peripheral Artery Disease
The ongoing Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study investigating ALD-301 in patients with peripheral artery disease continues to enroll patients. The study is being funded entirely by NHLBI/NIH. Cytomedix retains ownership of the commercial rights to this program and will continue to seek and pursue opportunities that would potentially allow the asset to be monetized and create additional value for shareholders.
Commercialization of AutoloGel for Chronic Wound
Cytomedix continues to focus heavily on commercial activities and make progress on the launch of AutoloGel under the Coverage with Evidence Development (CED) program. AutoloGel has been cleared by the FDA for use on a variety of exuding wounds and the Company is in the process of launching it, with Medicare coverage and sufficient payment, into the estimated $3.4 billion U.S. chronic wound market. The final payment decision by the Center for Medicare and Medicaid Services (CMS) came into effect on January 1st this year, significantly expanding the coverage for AutoloGel and allowing providers in the outpatient setting to treat a broad patient population with a variety of wounds.
As part of the ongoing commercial expansion, Cytomedix recently announced a number of senior management appointments and is in the process of building out its commercial team.
“We will continue to focus our time and resources on the successful development and implementation of our reimbursement and customer support functions of the AutoloGel System for chronic wounds,” continued Mr. Rosendale. “We have assembled a talented and experienced commercial team, and continue to work with CMS to expand access to AutoloGel within our Medicare National Coverage Decision.”
About Cytomedix
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for wound care. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma (“PRP”) gel for use on a variety of exuding wounds. For additional information please visit cytomedix.com.
SOURCE: Cytomedix
Post Views: 116
Results from RECOVER-Stroke Phase 2 Trial Show No Significant Clinical Benefit; Completion of R&D Restructuring Expected to Lead to Additional Cost Savings
Continued Strategic Focus on AutoloGelTM Launch and Building Profitable Wound Care Busines
GAITHERSBURG, MD, USA I May 5, 2014 I Cytomedix, Inc. (OTCQX: CMXI), a leading developer of biologically active regenerative therapies, and its wholly owned subsidiary, Aldagen, Inc., announced today the preliminary efficacy and safety results at 90 days from the RECOVER-Stroke phase 2 study in patients with neurological damage arising from an ischemic stroke and treated with ALD-401. Observed improvements in the primary endpoint (mean modified Rankin Score or mRS) were not clinically or statistically significant. In light of this outcome, Cytomedix plans to discontinue further funding of the ALDH Bright Cell development program and close its R&D Facility in Durham, NC. The Company remains focused on its commercial launch initiative for AutoloGelTM with the goal of driving sales in the estimated $3.4 billion U.S. chronic wound market.
“Ischemic stroke is a challenging medical condition with no effective therapeutic products available to help,” said Martin Rosendale, CEO of Cytomedix. “While the observed benefit of ALD-401 in the RECOVER-Stroke trial is disappointing, the ongoing NIH-funded PACE study in patients with peripheral artery disease (PAD) is approximately 30% enrolled and is continuing at a good rate. PAD is a serious medical problem affecting approximately 8 million people in the U.S., and can lead to chronic wounds, amputation, and death.
With the NIH supporting the PACE study, we believe that the planned closure of our Durham facility is a necessary strategic decision for the Company. The elimination of the associated R&D expense will further reduce our cash burn and is in line with our previously announced goal of building a more commercially focused company.”
Results from Phase 2 RECOVER-Stroke Trial and R&D Reorganization
The study results for patients followed 90 days post treatment with ALD 401 include:
· Group mean and categorical change differences in mean modified Rankin Score (mRS) were not different between the ALD-401 and sham treatment groups
· Secondary endpoints were not different between groups
· The safety findings at 90 days are consistent with past reviews by the Data Safety Monitoring Board. There have been no serious adverse events attributable to the use of ALD-401, demonstrating good tolerability and safety.
All patients will be followed for one year, and complete efficacy and safety data will be provided to the scientific community.
In light of the foregoing, Cytomedix plans to close its R&D facility in Durham, NC in May 2014. This decision is consistent with the Company’s ongoing realignment of its commercial operations to focus on the wound care market and is expected to result in annual savings of approximately $4 million.
PACE Study with ALD-301 in Peripheral Artery Disease
The ongoing Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study investigating ALD-301 in patients with peripheral artery disease continues to enroll patients. The study is being funded entirely by NHLBI/NIH. Cytomedix retains ownership of the commercial rights to this program and will continue to seek and pursue opportunities that would potentially allow the asset to be monetized and create additional value for shareholders.
Commercialization of AutoloGel for Chronic Wound
Cytomedix continues to focus heavily on commercial activities and make progress on the launch of AutoloGel under the Coverage with Evidence Development (CED) program. AutoloGel has been cleared by the FDA for use on a variety of exuding wounds and the Company is in the process of launching it, with Medicare coverage and sufficient payment, into the estimated $3.4 billion U.S. chronic wound market. The final payment decision by the Center for Medicare and Medicaid Services (CMS) came into effect on January 1st this year, significantly expanding the coverage for AutoloGel and allowing providers in the outpatient setting to treat a broad patient population with a variety of wounds.
As part of the ongoing commercial expansion, Cytomedix recently announced a number of senior management appointments and is in the process of building out its commercial team.
“We will continue to focus our time and resources on the successful development and implementation of our reimbursement and customer support functions of the AutoloGel System for chronic wounds,” continued Mr. Rosendale. “We have assembled a talented and experienced commercial team, and continue to work with CMS to expand access to AutoloGel within our Medicare National Coverage Decision.”
About Cytomedix
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for wound care. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma (“PRP”) gel for use on a variety of exuding wounds. For additional information please visit cytomedix.com.
SOURCE: Cytomedix
Post Views: 116
