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
About MissionIR:
MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html
