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news.Helix BioPharma (Helix) has received verbal notice from the US Food and Drug Administration (FDA) that its pending Topical Interferon Alpha-2b Phase II/III investigational new drug (IND) application has been placed on clinical hold.
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An IND application clinical hold is an order that the FDA issues to a clinical trial sponsor to postpone approval to conduct a proposed trial pending resolution of issues raised during IND application review.
Helix claimed that the clinical hold was issued only because the FDA requires additional product analytical information and not because of any problems relating to the planned Phase II/III trial design or Helix’s clinical/preclinical findings to-date.
Helix president John Docherty said that they welcome the FDA’s comments which will further aid them in preparing their Topical Interferon Alpha-2b product to meet commercial standards of biopharmaceutical analytical characterisation, and thereby facilitate the market authorisation process assuming successful completion of Helix’s planned pivotal trials.
Topical Interferon Alpha-2b is a prospective non-invasive treatment for women with potentially precancerous, low-grade cervical lesions.
Helix is in the process of defining a work plan to address the FDA’s requirements as quickly as possible.
One of the requirements is to extend the duration of product stability data, which the company estimates will take a minimum of three months to generate.