FDA Lifts Clinical Hold on Helix BioPharma (HBP) Topical Interferon Alpha-2b, Phase II/III IND
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Helix BioPharma Corp. (AMEX: HBP) reports that the "clinical hold" on its investigational new drug application for its Topical Interferon Alpha-2b, Phase II/III, low-grade cervical lesion efficacy trial has been removed by the United States Food and Drug Administration. The FDA completed its review of Helix's "clinical hold" complete response submission, which Helix filed as announced in its news release of October 12, 2011, and granted Helix approval to perform the planned clinical trial.
The Company is still in need of additional funding as well as strategic partner support before commencing this trial. As such, it does not currently have an estimated timeline for commencement or completion of this trial. The Company hopes, however, that this FDA approval will be helpful in generating the support it requires.
The Company is still in need of additional funding as well as strategic partner support before commencing this trial. As such, it does not currently have an estimated timeline for commencement or completion of this trial. The Company hopes, however, that this FDA approval will be helpful in generating the support it requires.
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