Trade Resources Industry Views German Regulatory Authority Approved Helix BioPharma's Clinical Trial Application

German Regulatory Authority Approved Helix BioPharma's Clinical Trial Application

The Federal Institute for Drugs and Medical Devices, the German regulatory authority, has approved Helix BioPharma's clinical trial application for a European Phase III efficacy trial of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.

The company requires a strategic partner, additional funding, and interferon alpha-2b raw material support so as to begin any such trial.

Helix, a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer, at present do not have an estimated timeline for initiation of such trial.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/german-regulatory-authority-approves-helix-trial-of-topical-interferon-alpha-2b-210512
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German regulatory authority approves Helix trial of topical Interferon Alpha-2b