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news.Helix BioPharma has filed IND clinical hold response with FDA for its planned topical interferon Alpha-2b phase II/III efficacy trial.
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Alpha-2b incorporates the company’s Biphasix drug delivery technology and provides a better means of delivering interferon-alpha-2b therapeutically to human papillomavirus (HPV) infected tissues.
FDA will take 30 days to review the process and make a decision if an applicant can proceed with its proposed clinical trial.
Following FDA approval, the company said it will require additional funding as well as strategic partner support to commence the pending US Phase II/III trial.