The company said that all ten of these patients, at all sampling time points, were found to have systemic interferon alpha-2b levels below the lower limit of detection (6.25 pg/ml) of the validated bioassay used in the study. The findings are consistent with the primary purpose of the study to verify that Topical Interferon Alpha-2b causes no systemic interferon alpha-2b exposure in patients following cervical application.
The company has also reported the preliminary interim findings for the secondary efficacy and safety endpoints from those patients who have completed the full study procedures. Of the ten patients reported above who have completed the 14 dose pharmacokinetic portion of the study, five have completed the full 35 dose safety and efficacy evaluations.
Three patients of the five showed resolution of their cervical intraepithelial neoplasia (CIN) upon colposcopic biopsy/histology at the conclusion of the study. Three also showed improvement of their Pap IIID squamous intraepithelial lesions upon cytological assessment at the conclusion of the study. None of the patients enrolled in the study to date have shown any local intolerance or have experienced any serious adverse events.
The company also noted that all of the data reported will require complete analysis at the conclusion of the study to verify these preliminary findings and draw final conclusions on the findings.
John Docherty, president of Helix BioPharma, said: “Given the uniformity of the primary endpoint findings to-date, we intend to conclude patient recruitment for this study once a total of twelve patients complete the pharmacokinetic analyses. We look forward to concluding enrollment and analyzing the complete data set from this important study.”