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

15-Sep-2005

Helix BioPharma 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.

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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