Pharma

Two stem cell therapies from Cytomedix to start trials; stroke study expands

When regenerative medicine firm Cytomedix (OTC:CMXI) acquired biotechnology company Aldagen, the stem cell-based stroke treatment in clinical trials was the centerpiece of the all stock deal. Cytomedix is now making moves to develop other stem cell treatments from its Aldagen acquisition. Two more clinical trials will start later this year, CEO Martin Rosendale told analysts […]

When regenerative medicine firm Cytomedix (OTC:CMXI) acquired biotechnology company Aldagen, the stem cell-based stroke treatment in clinical trials was the centerpiece of the all stock deal.

Cytomedix is now making moves to develop other stem cell treatments from its Aldagen acquisition. Two more clinical trials will start later this year, CEO Martin Rosendale told analysts on a conference call to discuss first-quarter financial results. Rosendale wouldn’t identify the indications that will be studied, and said only that they will be announced this summer: one for an arterial disease and the other a neurological condition.

Cytomedix’s goal is to ultimately find large pharmaceutical partners to commercialize these treatments. These additional clinical studies don’t represent those kinds of partnerships. Rosendale said there are two facilities that will conduct investigator-led clinical trials. But those trials will be funded by outside sources, not by Cytomedix.

The pipeline progress comes as Gaithersburg, Maryland-based Cytomedix gets the green light to proceed in phase 2 clinical trials for experimental ischemic stroke treatment ALD-401 following a positive recommendation from an independent data safety monitoring board. ALD-401 is an experimental stem cell treatment derived from a patient’s own bone marrow. Aldagen’s “bright cell” technology isolates stem cells that express high levels of the ALDH enzyme, which have the potential to promote healing and cell and tissue regeneration.

Cytomedix already has a portfolio of commercialized wound-healing and regenerative therapies. The Aldagen acquisition was intended to build up the company’s pipeline. But even as part of Cytomedix, Aldagen is shouldering most of ALD-401’s development risk. While the deal is valued at up to $40 million, Aldagen and its shareholders will see that full amount only if the experimental stroke treatment hits development milestones. Aldagen, which continues to operate in Durham, North Carolina as a Cytomedix subsidiary, received just $16 million up front in Cytomedix preferred stock.

The ALD-401 trial is designed to study 100 patients. Rosendale said the study is now up and running in five sites and will reach eight sites by the end of May. The study will cover 12 to 15 sites in the United States.

Cytomedix also reported positive data for another Aldagen stem cell therapy candidate. ALD-201 has completed a phase 1 study as a treatment for end-stage heart failure. Rosendale said that study showed ALD-201 was well tolerated and showed evidence of improving blood flow and improved clinical status. Findings were published in the American Heart Journal.

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