Cytomedix reorganizes R&D to cut cash burn

US biotechnology company Cytomedix (OTCQX: CMXI) will reorganize its R&D activities to reduce cash burn. As part of this initiative, the company’s ongoing financial support of the current RECOVER-Stroke trial and the underlying ALDH Bright Cell technology will be substantially concluded by the end of the year.

The company said it is exploring a range of strategic options for continuing its clinical programs beyond year end 2013, which options may include, among others, technology transfer, spinout, licensing or other similar transactions involving the underlying technology.

Cytomedix has restructured its R&D facility to bring available resources and spending in line with current and expected enrollment in the ongoing clinical programs. The RECOVER-Stroke trial with ALD-401 has now enrolled 39 patients. The company’s intention is to proceed with enrollment in the trial through 2013 with an enrollment goal of 50 patients at that time.  Depending on the success of the company’s efforts to pursue strategic options for continuing its clinical programs, the company may determine to conclude the study beyond December 31 and unblind the study data at the assessments of the primary efficacy endpoint, ie, 90 days post treatment of the last enrolled patient.

Study enrollment “slower than expected”

Martin Rosendale, chief executive of Cytomedix, said: “In line with our goal of building a more commercially focused and streamlined organization at Cytomedix, we have presently concluded to limit further investment in areas that are not part of our commercial business objectives. While we have made important progress with the RECOVER-Stroke trial and remain of the opinion that the ALDH bright cell adult stem cell population is novel and highly differentiated, we acknowledge that enrollment has been slower than expected.  We will continue to seek and pursue opportunities that would allow us to move the program forward and minimize the ongoing investment by Cytomedix beyond year end.”

Mr Rosendale added: “This decision, along with the licensing of the Angel System recently announced, is expected to substantially reduce our cash burn and allow us to focus our efforts exclusively on AutoloGel and the significant opportunity we believe exists in the chronic wound care market. We believe this is the most financially responsible action we can undertake to preserve and grow shareholder value.”

The company will continue to support third party funded studies while it enrolls the stroke study through the end of the year. For example, the ongoing Phase II PACE study, is funded by the National Heart, Lung and Blood Institute, and is looking at the safety and value of bright cells for the treatment of intermittent claudication, a form of peripheral arterial disease.