Helix BioPharma Corp. (奧羅拉，Aurora)宣布己完成外用型Alpha-2B幹撓素(Topical Interferon Alpha-2B )的第二期臨床測試，包括病人的登錄及處理治療作業。
對象是具有子宮頸低度鱗狀表皮病變(low-grade squamous intraepithelial lesions ，LSIL)，而且人類乳突病毒(HPV，Human Papilloma Virus)檢測是陽性的婦女。
這項測試研究主要是用來評估外用型Alpha-2B幹撓素的安全性和有效性，針對在細胞學方面己確定的LSIL病人，以及用聚合酵素鏈鎖反應(polymerase chain reaction，PCR)技術已確認的人類乳突病毒感染患者。
病人在陰道內每周用藥三次，連續六周，接著後續追蹤連續六周。主要的臨床測試最終要求項目是要能決定出病人在這十二周療程中，在不正常抹片採樣(Pap smear)結果方面，能夠得到改善的比例值。其它的評估值包括安全性和耐受性、測試前後組織學檢陰道鏡檢結果、人類乳突病毒的聚合酵素鏈鎖反應(polymerase chain reaction，PCR)定性測試等。
此外，公司也研究了作為對照組的第二組病患族群，這些病患沒有得到任何治療。這次共有40位參加第二期臨床測試，每一組各有20位，測試中沒有觀察到任何嚴重的副作用。公司正在進行臨床測試的數據收集及最後分析工作，預定在2007年第一季完成分析並提出數據整合報告。
英文原文：
Helix Biopharma Corp. Completes Phase 2 Clinical Study With Topical Interferon Alpha-2b In Patients With Low-Grade Squamous Intraepithelial Lesions
Helix BioPharma Corp. (TSX, FSE: 「HBP」) announced today completion of enrollment andThe study was designed to evaluate the safety and effectiveness of Topical Interferon Alpha-2b in patients with cytologically confirmed LSIL and polymerase chain reaction (「PCR」) confirmed HPV. Patients received Topical Interferon Alpha-2b therapy applied intravaginally three times a week for a period of six weeks, followed by a six week follow-up period. The primary study endpoint is to determine the proportion of patients with resolution of their abnormal Pap smear during the twelve week study duration.
Other study assessments include safety and tolerability, pre- and post-study histological examinations by way of colposcopy and qualitative assessment of HPV-positive status using PCR. In addition, the Company studied a second patient population that received no treatment whatsoever as a comparator to the treatment population.
As planned, 40 patients were enrolled across the two patient groups, divided into 20 patients in each group. No serious adverse drug reactions were reported in the study. The Company is completing analytical work on patient samples collected over the duration of the patient testing and will be gathering and analyzing the final data. The Company expects to complete all data analyses and report the final integrated study findings during the first quarter of calendar-2007.
The Phase 2 study was conducted at four clinical sites in Germany under the guidance of Prof. Achim Schneider, MD, MPH, a world expert in the field of cervical cancer. Prof. Schneider is the Director of the Department of Gynecology at one of the largest university hospitals in Europe, The Charité-Universitätsmedizin Berlin.
About Topical Interferon Alpha-2b
Interferon alpha-2b is an immune system modulator that is active against a variety of HPV-induced lesions. Interferon alpha-2b is thought to function by triggering an antiviral response within infected cells, by activating certain intracellular enzymes which cause degradation of viral RNA, and by mobilizing the body's natural immune system to destroy the infected cells. Interferon alpha-2b has been widely used 3-305 Industrial Parkway South Aurora, Ontario, Canada, L4G 6X7 Phone: (905) 841-300
Fax: (905) 841-2244 commercially as a treatment for certain HPV induced lesions, but is not generally favoured due to the fact that conventional administration requires painful intradermal injection by a medical professional. Furthermore, intradermal injection is restricted to visible lesion administration, while HPV infection is often characterized by both visible and non-visible (i.e. sub-clinical) lesions. Helix's Topical Interferon Alpha-2b is expected to offer a safe, discreet, self-administered, pain-free therapy that can be broadly applied across the entire affected tissue area. Helix anticipates that this will prove highly advantageous not only from a patient compliance perspective, but also from an efficacy standpoint, by offering a new means of targeting both visible and sub-clinical lesions and treating cervical infection that was previously impractical to treat via injection.
About Helix BioPharma Corp.
Helix BioPharma Corp. is a biopharmaceutical company specializing in the field of cancer therapy. The Company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. Helix’s product development initiatives include its Topical Interferon Alpha-2b and its novel L-DOS47 new drug candidate. Helix is listed on the TSX under the symbol 「HBP」.
treatment in its Phase 2 clinical study of Topical Interferon Alpha-2b in women with lowgrade squamous intraepithelial lesions (「LSIL」) that are positive for human papilloma virus (「HPV」) infection.