Cytomedix says audit, trial complete with positive results for AutoloGel to treat diabetic foot ulcers

By E. Janene Geiss

Philadelphia, Dec. 14 - Cytomedix, Inc. said Wednesday that the audit of its clinical investigational sites and trial results for diabetic foot ulcers has been completed.

The company undertook this audit with the assistance of an independent consultant, a former Food and Drug Administration branch chief responsible for Bio-Research Monitoring, according to a company news release.

During the audit, Cytomedix discovered that some investigational centers had enrolled patients who did not meet the inclusion criteria or had not provided treatment according to the study protocol. After correcting for these types of deviations, the trial yielded 40 patients, officials said.

Analysis of the size of wounds in the study shows that 35 out of the 40 patients, or 88%, had wounds that were less than or equal to 7 square centimeters in area and 2 cubic centimeters in volume.

For these most common wound sizes in the study, the healing rate for the AutoloGel group was 81.3% and the control group was 42.1%.

The company said the difference of 39.2% between these rates "is clearly statistically significant."

Within the full cohort of the 40 patients, 68.4% of the patients treated with AutoloGel healed with full wound closures and 42.9% of patients treated in the control group achieved full wound closures. The difference of 25.5% between the healing rates of the AutoloGel group versus the Control group is very close to statistical significance with a p-value of 0.125, officials said.

The healing rates of AutoloGel at 81.3% for the most common wound sizes in the study and 68.4% for all wound sizes are very competitive with, or better than, most other wound care products cleared by the FDA and covered by Medicare reimbursement, officials said.

The control group patients were not on placebo, rather they were treated using a saline gel cleared by the FDA for wound treatment. It is important to point out that if the control group patients healed at the originally anticipated rate of 20% to 30% (which was based on published literature), the difference between the healing rates in the AutoloGel group versus the control group would have been even more strongly statistically significant, officials said.

"We are very pleased that our product achieved such high healing rates for diabetic foot ulcers for all wound sizes, particularly as compared to other products on the market. It should be noted that for 88% of the wounds in the study, the healing rate was an outstanding 81% for AutoloGel," said Kshitij Mohan, chairman and chief executive officer, in the release.

"Despite a smaller than anticipated number of patients who were treated in compliance with the complex clinical protocol and a much higher than anticipated healing rate in the control group, the difference in healing rates between the two groups was clearly statistically significant for the most common wound sizes and very close to statistical significance for all wound sizes," Mohan added.

The company said in the first quarter of 2006 it planned to submit an application requesting FDA clearance based on these clinical trial results.

Cytomedix is a Rockville, Md., biotechnology company specializing in research, development, licensing and systems for treating non-healing chronic wounds including diabetic ulcers.

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