viewHelix BioPharma Corp.

Helix BioPharma's "clinical hold" status removed for Interferon Aplpha-2b trial


Helix BioPharma (TSE:HBP)(AMEX:HBP) said Friday that the US FDA removed the 'clinical hold' on its investigation new drug application for its topical Interferon Alpha-2b, intended for the treatment of low-grade cervical lesions, allowing the company to move forward with its clinical trials.

However, the company said it requires additional funding and a strategic partner in order to commence the study, but said it expects the news to accelerate that process.

As such, it has no estimated timeline for the start or completion of the trial.

The proposed phase II/III study will be a randomized, double-blind, vehicle-controlled study of topically-applied Interferon Alpha-2b in 492 female subjects with cervical intraepithelial neoplasia (CIN) lesions.

The study will be 12 months long, including treatment and follow-up. Each patient will self-administer the topical treatment every second day, excluding menstruation days, until 35 doses have been completed.

The proposed primary endpoint of the study is the resolution of CIN lesions at month 12 of the study, determined by a cervical biopsy, together with the results of a pap smear.

CIN is a growth or mutation of the body's cervical cells. The disease is not cancerous, though it is potentially pre-malignant. However, it is often stable, curable, and is often cured by the body's own immune system.

About 1.3 million women are diagnosed with CIN each year in the U.S. alone, and there are no pharmaceutical or non-surgical treatments available.

Helix said its goal in the development of Interferon Alpha-2b is providing a safe and effective treatment for CIN at the time of diagnosis, as a proactive alternative to traditional surgical treatments.

The topical drug works to induce the immune system through the use of cytokines, small cell-signaling proteins that have chemotherapeutic properties.

On the Amex Exchange, Helix shares were down 4.08 percent to $1.88, as of 9:53 am EDT.

Quick facts: Helix BioPharma Corp.

Price: 1 CAD

Market: TSX
Market Cap: $132.93 m

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