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Helix BioPharma Provides Updates on Topical Interferon Alpha-2b and L-DOS47 Following Pre-IND Meetings With the U.S. FDA
Date:10/6/2009

stated strategy of conducting a well-controlled, Phase III confirmatory clinical trial in addition to its planned U.S. Phase II/III trial in order to establish the efficacy and safety of its product for marketing authorization purposes. Helix intends to continue to make preparations to conduct a European Phase III trial for this purpose. The timing of filing the regulatory submissions for this trial has not yet been established, however, it is not expected to precede the filing of its planned U.S. Phase II/III IND.

Topical Interferon Alpha-2b - Anogenital Warts Indication

Enrollment in the ongoing Phase II clinical trial of Topical Interferon Alpha-2b in patients with anogenital warts ("AGW") in Sweden and Germany is progressing on track. The Company expects the last patient to be enrolled on or around the end of the first quarter of fiscal 2010. The study has now enrolled over 85% of the required 120 patients. Future considerations for the AGW program were not part of the latest pre-IND meetings, as Helix is awaiting the results from the ongoing Phase II AGW trial prior to initiating further development plans for this indication.

L-DOS47

At the pre-IND meeting with the FDA for L-DOS47, the FDA generally agreed with Helix's proposed remaining non-clinical pharmacology and toxicology studies as well as its remaining GMP manufacturing program initiatives prior to IND filing. The FDA provided Helix with recommendations for improvements in some areas including the development of additional quality control analytical testing methods to characterize batches of L-DOS47 clinical supplies and their intermediates.

As previously stated, Helix intends to initiate its clinical testing program with L-DOS47 with studies in both North America and in Europe. In Europe, Helix has been developing relationships with key opinion leader clinicians and contract research organizations in Poland with a plan to co
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