Helix receives approval to conduct a clinical trial of Topical Interferon Alpha-2b in Sweden

Sep 12 2005

Helix BioPharma today announced that it has received approval from Sweden's drug regulatory authority, the Medical Products Agency (MPA), to conduct a Phase II clinical trial of Topical Interferon Alpha-2b in patients with ano-genital warts (condylomata acuminata), who are positive for infection with the human papilloma virus (HPV).

The trial is intended to assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double-blind, randomized design. The trial will be conducted at multiple centers in Sweden, under the direction of Dr. Pal Wolner-Hanssen, the coordinating investigator who is located at the University Hospital of Lund.

"We are very pleased to receive this approval from MPA after months of preparations," said Mr. John Docherty, Vice President of Corporate Development for Helix BioPharma Corp. "This is a critical step towards commencing the clinical program for the second major indication to be sought for Topical Interferon Alpha-2b."

Based on having received this approval, the Company intends to commence preparations to conduct the trial, with a view to beginning the trial in concert with raising additional required capital.

Helix's Topical Interferon Alpha-2b is currently being assessed clinically in a multi-center Phase II study in Germany for the treatment of Low-Grade Squamous Intraepithelial Lesions (LSIL), a form of cervical dysplasia, in women who are positive for HPV infection. The Company is developing Topical Interferon Alpha-2b for two indications, LSIL and ano-genital warts.

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