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Helix Receives Approval to Open Sites in Germany for its Ongoing Clinical Trial With Topical Interferon Alpha-2b in Patients With Ano-Genital Warts
Date:9/22/2008

AURORA, Ontario, Sept. 22 /PRNewswire/ -- Helix BioPharma announced today that it has received the necessary regulatory approvals to open clinical sites in Germany to expand upon its clinical trial with Topical Interferon Alpha-2b in patients with ano-genital warts, which is presently underway in Sweden.

"We are pleased to have received approval to open these additional clinical sites," said John Docherty, President of Helix BioPharma. "The opening of sites in Germany will grant us access to expanded clinical resources and a larger patient pool in order to enhance the recruitment rate of our trial."

The opening of additional sites in Germany is intended to compensate for a lower than expected patient enrollment rate thus far in Sweden. These sites have been added in order to speed the pace of enrollment to support Helix BioPharma's objective of completing patient enrollment by the end of the Company's fiscal fourth quarter, ending July 31, 2009.

About the Clinical Trial

The trial is designed to assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double blind, randomized design over an examination period of four months per patient. One hundred twenty patients are to be enrolled in the trial. Half will receive a placebo and half will receive Topical Interferon Alpha-2b. Only female subjects are to be enrolled in the trial in order to avoid inter-sex treatment variations. Trial subjects will self-administer Topical Interferon Alpha-2b twice daily for five consecutive days per week over a treatment period of eight weeks, with a follow-up visit at 16 weeks. The primary endpoint for the trial will be comparison of the proportion of patients with complete clearance of their baseline lesions during the eight week treatment period.

Dr. Pal Wolner-Hanssen of the University hospital in Malmo MAS, Sweden will remain the overall coordinating investigator for the trial, and Professor Dr. med. Eggert
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SOURCE Helix BioPharma Corp.
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