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news.Helix BioPharma has released Phase II pharmacokinetic (PK) findings for Topical Interferon Alpha-2b in patients with low-grade cervical lesions.
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In the trial, all 14 patients were found to have circulating interferon Alpha-2b levels below the bioassay’s lower limit of detection (6.25 pg/mL) at all sampling time points.
The findings confirm that Topical Interferon Alpha-2b causes no systemic interferon Alpha-2b exposure in patients following cervical application using the dose and regimen in this study.
Helix has achieved last-patient-out with respect to the study’s secondary safety and efficacy endpoints. All patients enrolled in the study have completed the prescribed study procedures beyond the PK primary endpoint portion of the study. Helix will now proceed to closing of the database, secondary endpoint analyses, and final reporting.
John Docherty, president of Helix BioPharma, said: “An important design feature of Topical Interferon Alpha-2b is to remain localized at the application site in order to optimize efficacy and minimize side effects.
“The positive outcome of the PK portion of this Phase II study confirmed that Topical Interferon Alpha-2b did not enter the systemic circulation in significant quantities. We expect this data to provide strong support for our planned US Phase II/III IND and European Phase III CTA filings for this important therapeutic indication.”