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Accentia Biopharmaceuticals Announces Favorable Interim Blinded,Data on SinuNase in Its Fast-Tracked Pivotal Phase 3 Clinical Trial,for Chronic Sinusitis

TAMPA, Fla.--(BUSINESS WIRE)--Jun 28, 2007 - Accentia Biopharmaceuticals, Inc. (NASDAQ: ABPI) announced on Wednesday, June 27 at the Jefferies Healthcare Conference that its interim analysis of the blinded data on the first fifty patients in the Fast-Tracked Phase 3 clinical study of SinuNase(TM), at 8 weeks post-randomization, has demonstrated substantial improvement in resolution of one or both of the cardinal symptoms of chronic sinusitis, and substantial improvement in intranasal polyposis. Resolution of both cardinal symptoms at the end of 16 weeks is the primary endpoint of the ongoing Phase 3 study. Based on this interim blinded data, approximately 42% of patients randomized reported resolution of one or both cardinal symptoms. In addition, approximately 47% of patients were evaluated as having improved endoscopy scores. It should be noted, prior to randomization, potential trial participants were required to irrigate with saline twice daily for two weeks and only those who showed no placebo effect were randomized. The randomization between SinuNase and placebo control is 1:1, meaning that 50% of the patients in the blinded interim analysis should be on SinuNase, and 50% on placebo control.

"The data reported is very encouraging," said Dr. Frank E. O'Donnell Jr., Chairman and Chief Executive Officer of Accentia Biopharmaceuticals. "While we cannot determine which patients are receiving SinuNase and which are receiving placebo control until the study is completed and unblinded, the fact that there are resolution of symptoms and improvement in endoscopy in a substantial percentage of patients suggests to me that we are on track to reach our anticipated outcome for SinuNase in the Phase 3 study. It seems unlikely to me that patients receiving placebo would have a substantial improvement in polyps. In fact, in patients who experienced no resolution of symptoms, the endoscopy scores improved by just 2%. In pa
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