Helix BioPharma Corp. (TSX, FSE: HBP; Pink Sheets: HXBPF) today announced that the first ten patients that have been enrolled in its Phase II pharmacokinetic study of Topical Interferon Alpha-2b in patients with low-grade cervical lesions have completed the pharmacokinetic primary endpoint analyses with positive findings.
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. These findings are consistent with the primary purpose of the study: to verify that Topical Interferon Alpha-2b causes no significant systemic interferon alpha-2b exposure in patients following cervical application.
"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," said John Docherty, president of Helix BioPharma. "We look forward to concluding enrollment and analyzing the complete data set from this important study."
Helix also announced preliminary interim findings for the secondary efficacy and safety endpoints from those patients who have completed the full study procedures to-date. Of the ten patients reported above who have completed the fourteen dose pharmacokinetic portion of the study, five have also completed the full thirty-five dose safety and efficacy evaluations. Three of these 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 significant local intolerance or have experienced any serious adverse events. Helix also noted that all of the data reported here will require complete analysis at the conclusion of the study to verify these preliminary findings and draw final conclusions on the findings.
Additional patients are presently in screening or scheduled to be enrolled into the study in the coming weeks. Any patients who are confirmed eligible for enrollment will continue to be enrolled into the study, up to the time Helix concludes patient recruitment. Based on the foregoing, Helix expects that the study will over-enroll several patients beyond the minimum of twelve required for the primary study endpoint, and that it will take until the middle of its fourth quarter of fiscal 2010 for all enrolled patients to complete the study. Assuming the full study findings are positive, and the success of Helix's ongoing GMP manufacturing scale-up program, Helix intends to proceed with filing its planned U.S. Phase II/III IND for this indication around the end of its fourth quarter of fiscal 2010 and its planned European Phase III CTA filing thereafter.
In light of its success in enhancing the patient recruitment rate in this study over recent months, Helix has concluded that it is no longer necessary to open the additional clinical sites it was considering in order to complete this study.
SOURCE Helix BioPharma Corp.