Symbollon Pharmaceuticals says its pain therapy IoGen flunked a late stage trial for moderate to severe cyclic pain associated with fibrocystic breast disease. And the results could well threaten the biotech's continued operations.
Researchers said there was no statistically significant difference between the therapy and a placebo on the primary endpoint of pain reduction. Nor was there a significant difference in fibrosis reduction, a secondary endpoint.
"We are extremely surprised and disappointed by the high placebo results in this study," said Paul Desjourdy, president and CEO of Symbollon Pharmaceuticals. "While we will continue to evaluate the data, the results of this study will severely limit our ability to proceed with the clinical development of IoGen. Based on the company's limited resources, management and the board of directors will be evaluating the company's ability to continue operations. We have adequate resources to continue operations through June. In light of these clinical results, it may be difficult for us to raise additional resources. Our focus will be to maximize shareholder value by leveraging the company's proprietary technology."
The Framingham, MA-based biotech lost slightly more than $3 million in the first nine months of 2007, citing increased costs for advancing IoGen.Â
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