BioSurface Technology Inc. (BST) announced late Tuesday thatit has put on hold clinical trials of its Acticel wound dressing indonor site wounds because an interim analysis of the resultsproved equivocal.
The Cambridge, Mass., company (NASDAQ:BSRF) said that it willcontinue its ongoing and planned clinical trials of Acticel inother major wound healing indications, such as deep partialthickness burns and pressure ulcers.
The decision follows a planned interim analysis of the donorsite trial data on 42 patients. These data showed a small butequivocal reduction in average healing time of donor sitestreated with Acticel as compared to controls. They did notcorroborate the results of previous company-sponsored pilotstudies and other academic studies that found a clinicallysignificant reduction in healing time of wounds treated withBST's "living bandage."
The term "clinically significant" in this case means "greaterthan 20 percent reduction in healing time compared to controldressings," explained David Castaldi, BST's president and chiefexecutive officer.
In the earlier trials, the cultured epidermal allografts reducedhealing time by 33 percent to 50 percent, Castaldi toldBioWorld. The results of five of the seven studies have beenpublished in scientific journals; the others have been submittedfor review or were presented last spring at the MedicalResearch Forum in Advanced Wound Care meeting in NewOrleans.
BioSurface is conducting an intensive analysis of the data todetermine how best to proceed with further studies in thedonor site indication.
"As yet we have no explanation for the difference between theresults obtained in this trial and those obtained in previouspilot trials, which produced clinically significant reductions inhealing times, nor have we had time to fully evaluate theimplications of these results for our other clinical trials,"Castaldi said.
But he emphasized that "we continue to have confidence in theproduct. ... There's nothing to indicate that we should changeour plans" to continue with the deep partial thickness burntrial, to recruit investigators for the trial on pressure ulcers orto continue with preparations for the trials on venous anddiabetic ulcers.
BioSurface completed its initial public offering just six weeksago, on Jan. 27. BST not only closed the IPO at the top of itsasking range of $12 a share, but offered 500,000 more sharesthan it had anticipated, for a total of 2.5 million shares. Thestock closed unchanged Tuesday at $8.38 a share.
-- Jennifer Van Brunt Senior Editor
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