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Helix BioPharma Corp. Announces Positive Phase II Pharmacokinetic Findings for Topical Interferon Alpha-2b in Patients With Low-Grade Cervical Lesions
Helix BioPharma Corp. Announces Positive Phase II Pharmacokinetic Findings for Topical Interferon...
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\n Jun. 23, 2010 (Canada NewsWire Group) -- \n >\n\n Helix BioPharma Corp. (TSX, FSE: "HBP" / OTCQX: HXBPF) today announced positive Phase II pharmacokinetic ("PK") findings for Topical Interferon Alpha-2b in patients with low-grade cervical lesions.\n\nAll 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. These findings confirm that Topical Interferon Alpha-2b causes no significant systemic interferon Alpha-2b exposure in patients following cervical application using the dose and regimen in this study.\n\n"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," said John Docherty, president of Helix BioPharma. "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 U.S. Phase II/III IND and European Phase III CTA filings for this important therapeutic indication."\n\nHelix also announced that it 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.\n\n >\n\nThe clinical study employed an open-label, single-arm design and enrolled a total of 14 female patients. Eligible women were between 18 and 45 years of age, presented with mild to moderate CIN (CIN1 or CIN2 respectively) confirmed by biopsy/histology, had a cytological diagnosis of Pap IIID not older than 12 months and were human papillomavirus (HPV)-positive confirmed by the Hybrid Capture® 2 HPV-DNA test. The primary objective of the study was to determine the multiple-dose pharmacokinetic profile of Topical Interferon Alpha-2b following intravaginal application every other day of a total of 14 doses of the cream. Following the pharmacokinetic portion of the trial, assessment of the secondary efficacy and safety parameters continued until 35 doses of the cream ...