Helix BioPharma Corp., a biopharmaceutical company developing drug candidates for the prevention and treatment of cancer, has filed a clinical trial application (CTA) in both Germany and the United Kingdom, with the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and the Medicines and Healthcare Regulatory Authority (MHRA) respectively. The company is seeking approval to perform its planned European phase III efficacy trial of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.
Topical Interferon Alpha-2b is the company’s most advanced product in development. By incorporating Helix’s proprietary Biphasix™ drug delivery technology, Topical Interferon Alpha-2b is designed to offer a superior method of delivering interferon alpha-2b therapeutically to HPV-infected tissues. The product is designed for patients with low-grade cervical lesions for which there is no available pharmaceutical therapy in the current 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,” John Docherty, president of Helix stated in the press release. “Together, these two pivotal efficacy trials, if successful, are intended to support U.S. and European marketing authorizations for the product for this indication.”
Helix selected Germany 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. In addition, both Germany and the UK have a large population from which to recruit prospective patients.
The CTA process is preceded by a two-week initial screening process followed by a 30-day CTA review for each jurisdiction. The proposed 12-month phase III trial is planned to be a randomized, double-blind study of Topical Interferon Alpha-2b. The company will enroll approximately 492 female patients who will receive a dose regimen identical to the recently completed phase II pharmacokinetic study of Topical Interferon Alpha-2b.
Helix said that contingent on their success, results of its U.S. phase II/III trial and European phase III trial will be submitted together in order to seek U.S. and European marketing authorizations for the product for this indication.
However, Helix needs additional funding and a strategic partner support before commencing this trial, and as such, the company cannot offer an estimated timeline for start or completion of this trial.
For more information visit www.helixbiopharma.com
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