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Helix BioPharma Announces Q3 2009 Financial Results and Provides Product Development Update
Date:6/15/2009

on of such activities, the Company now expects its IND filing to occur within approximately six months of the previously anticipated date of July 31, 2009. The success of upcoming program efforts, including the remaining GMP scale-up production activities, the outcome of its upcoming pre-IND meeting and the outcome of the remaining non-clinical pharmacology and toxicology studies will ultimately determine the timing of Helix's Phase I/II IND/CTA filings.

Topical Interferon Alpha-2b Product Development Update - Cervical Displasia Indication ("LSIL")

During the quarter, Helix received regulatory approval to conduct its European Phase II pharmacokinetic study in human subjects prior to initiating its planned Phase IIb/III trials, and enrollment in the study is actively underway.

In parallel with its clinical progress, Helix has continued to advance its GMP production activities in anticipation of the Phase IIb and III trials in the United States and Europe respectively. Although all activities in preparation for the planned Phase IIb/III trials are progressing, the Company has experienced some delays associated with the GMP manufacturing scale-up program and in initiating the human pharmacokinetic study.

Helix is preparing to conduct a pre-IND meeting with the FDA to confirm its pivotal efficacy trial plans. Helix has submitted its formal meeting request, and is awaiting a reply from the authority confirming their timing availability. The outcome of this meeting along with the success of Helix's remaining GMP manufacturing scale-up and human pharmacokinetic study activities, will determine the timing of Helix's U.S. IND filing which was previously anticipated by July 31, 2009 but is now not expected before the end of Helix's fiscal 2010 first quarter ending October 31, 2009. The new expected timing of filing the confirmatory European Phase III Clinical Trial Application has not yet been establish
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SOURCE Helix BioPharma Corp.
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