Helix BioPharma Files Clinical Trial Application in Both Germany and UK
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Helix BioPharma Corp. has announced that it has filed a clinical trial application in both Germany and the United Kingdom, with the Bundesinstitut für Arzneimittel und Medizinprodukte and the Medicines and Healthcare Regulatory Authority respectively, seeking approval to perform its planned European Phase III efficacy trial of Topical Interferon Alpha-2b in patients with low-grade cervical lesions in one or both jurisdictions.
Topical Interferon Alpha-2b is the Company's most advanced product in development and incorporates its proprietary Biphasix™ drug delivery technology, designed to offer a superior means of delivering interferon alpha-2b therapeutically to HPV-infected tissues.
Topical Interferon Alpha-2b is designed to address the large, untapped pharmaceutical marketplace for patients with low-grade cervical lesions, with approximately 1.3 million new cases diagnosed annually in the US alone and no available pharmaceutical therapies on the market.
"This is a significant step for Helix. We are seeking approval to conduct what we intend to be a second, confirmatory efficacy trial of Topical Interferon Alpha-2b in patients with low-grade cervical lesions, to complement and parallel our recently approved U.S. Phase II/III efficacy trial," said John Docherty, president of Helix BioPharma Corp.
Docherty continued, "Together, these two pivotal efficacy trials, if successful, are intended to support U.S. and European marketing authorizations for the product for this indication."
The Company selected Germany as one jurisdiction for filing its CTA due to the fact that it has a history of conducting clinical studies with the product in Germany in the past, and because Germany has a large population from which to recruit prospective patients.
The United Kingdom was selected as a second jurisdiction for filing as it also offers a large prospective patient population within the European community.
The CTA review process is preceded by an initial screening process that typically requires two weeks, which may be extended if additional information is required.
Once that process is complete, the CTA review process typically requires 30 days in each jurisdiction, during which the BfArM and MHRA will decide if Helix is permitted to proceed with its proposed clinical trial, or if additional information is required prior to making that decision, in which case the time period for the CTA review process would be extended.
Beyond the regulatory authorizations Helix is now seeking, it 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.
