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news.Helix BioPharma has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) seeking approval to perform its planned Phase II/III efficacy trial of Topical Interferon Alpha-2b in patients with low-grade cervical lesions.
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Topical Interferon Alpha-2b incorporates Helix BioPharma’s proprietary Biphasix drug delivery technology, designed to offer a superior means of delivering interferon-alpha-2b therapeutically to HPV-infected tissues.
Helix BioPharma said that the proposed Phase II/III trial is planned to be a randomised, double-blind, vehicle-controlled study of Topical Interferon Alpha-2b in patients with cervical intraepithelial neoplasia grade 1 or 2 lesions (CIN 1 or CIN 2 respectively).
The proposed primary study endpoint will be the resolution of CIN 1 or CIN 2 at month 12, determined by colposcopic directed cervical biopsy together with Pap smear cytology free of ASC-H (atypical squamous cells that cannot exclude high-grade squamous status), AGUS (atypical glandular cells of undetermined significance), LSIL (low-grade squamous intraepithelial lesions), HSIL (high-grade intraepithelial lesions), and adenocarcinoma in situ (AIS) or adenocarcinoma.
Helix BioPharma president John Docherty said that it was a significant milestone achievement for Helix.
"We are seeking approval to commence what we intend to be, in conjunction with our planned European Phase III trial, the final pivotal efficacy trial stage of development for Topical Interferon Alpha-2b addressing this important therapeutic indication," Docherty said.
"We are hoping that the FDA review and approval process will proceed successfully, since we previously completed a pre-IND meeting with the agency to identify its requirements for this IND filing."