Helix BioPharma Corp. has two on-going clinical trials for their Topical Interferon Alpha-2b:
1. IFN 001: Treatment of genital warts with Interferon alpha-2b Cream: a randomized, double blind, placebo-controlled study
| Sponsors and Collaborators: |
Helix Product Development (Ireland) Limited, a wholly-owned subsidiary of Intercon Pharma. |
| Information provided by: |
Helix Product Development (Ireland) Limited, a wholly-owned subsidiary of Intercon Pharma. |
RATIONALE: Currently, there are many treatments available for genital warts. Most rely on tissue destruction by physical ablation or cytotoxic chemicals, usually (but not exclusively) in a physician’s office. Among the various treatments, interferon alpha (like imiquimod), differs in that its action depends on immunomodulatory activities; however, the currently approved intralesional route of administration, like other therapeutic approaches, is painful and involves numerous visits to the physician’s office. Topical imiquimod is suitable for self-medication; however, due to its cytotoxic properties, it can be classified among the more painful and destructive approaches to genital wart removal.
Helix has developed a formulation of interferon alpha-2b that has been demonstrated to elicit a potent anti-viral effect. These results are encouraging from the point of view of developing a new, painless and convenient approach to the treatment of genital warts.
PURPOSE: To compare the efficacy and safety of topical Interferon alpha-2b Cream to vehicle for the treatment of condylomata accuminata in female patients.
| Condition |
Intervention |
Phase |
| Ano-Genital Warts |
Drug: Interferon Alpha-2b Cream
Procedure: Topical Application |
Phase II |
Study Type: Interventional
Study Design: Prospective, double-blind, randomised, two groups (active and vehicle) multi-centre study. Only female patient treatment groups.
Official Title: Treatment of genital warts with Interferon alpha-2b Cream: A randomised, double-blind, placebo controlled study.
Start Date: December, 2006
Clinical Sites: There are 5 sites in Sweden and 12 sites in Germany
Detailed Description:
OBJECTIVES:
Primary Endpoints:
- Proportion of patients with complete clearance of baseline warts in the ITT population.
OUTLINE (TRIAL DESIGN): This is a double blind, randomized, two groups (active and vehicle) multi-center study. Only female patient treatment groups. The study drug, Interferon alpha 2-b Cream, is a preparation of interferon alpha-2b for topical application to the external genital and perianal region based on Helix’ proprietary Biphasix™ drug formulation technology.
All patients will apply study cream to the external genital area twice daily, for 5 consecutive days, Monday through Friday. Patients will apply study cream for 8 weeks.
All the patients whose warts have resolved will be asked to attend a follow-up visit 8 weeks after their last treatment visit to evaluate the recurrence of baseline warts.
PROJECTED ACCRUAL: A total of 120 patients will be enrolled, 60 in each group.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Criteria
DISEASE CHARACTERISTICS: Human Papillomavirus (HPV) infections have reached epidemic proportions, with over 40 million people estimated to be infected in North America and Europe. HPV is the most common sexually transmitted disease in the world today, primarily affecting sexually active youth between the ages of 15-25, and is continuing to spread at a rate of over 5 million new cases each year in the US. The most common clinical manifestation of the virus is condylomata acuminate (genital warts).
Treatment options today are limited by pain and burning sensations, and are not always effective in clearing (treating) the wart or preventing wart recurrence. If opted for, these treatments include topical preparations (e.g. podophyllotoxin, Imiquimod), ablative surgical procedures (e.g. cryotherapy, excision, electrosurgery, laser surgery) and interferon alpha-2b injections on a visible wart-by-wart basis. All of these therapies are directed at the visible lesion (the words lesion and wart will be used interchangeably).
Often times, physicians will prefer to not treat a patient who presents with genital warts as the side effects of the approved treatments are worse than the manifestation of the warts. Warts can spontaneously regress if left untreated.
Investigators
Study Chair:
Pål Wälner-Hanssen, MD, Ph.D.
Department of Obstetrics and Gynecology
Univeristy Hospital of Lund, Sweden
LKP: Germany
Professor Eggart Stockfleth
More Information
Publications of Results: Not Available
Study ID Numbers:
Protocol Code Number: IFN001
EudraCT Number: 2005-000162-40
For more information or potential participation, please contact:
Encorium Sweden
Torshamnsgatan 28a
SE-146 40 Kista
Sweden
www.encorium.com
tel +46 8 5648 8270
2. IFN 005: Multiple-Dose Pharmacokinetic, Efficacy and Safety Study of Interferon alpha-2b in Women with Cytological diagnosis of Pap IIID and confirmed HPV Positive Status: a mono-centre, open-label study
| Sponsors and Collaborators: |
Helix BioPharma Corp. |
| Information provided by: |
Helix BioPharma Corp. |
RATIONALE: Interferon alpha-2b is known to be active against a variety of HPV-induced lesions, particularly cutaneous lesions, such as genital warts. A topical intravaginal application of Interferon alpha-2b representing a non-invasive therapy could eradicate HPV and reverse the abnormal cytology during the early stages of the disease. Such a treatment option would provide a significant benefit to a large group of young women being at risk of developing cervical cancer.
Helix’s Interferon alpha-2b Cream is expected to offer an effective and practical treatment option for the early stages of HPV-induced cervical lesions with the goal to avoid invasive treatment measures for precancerous conditions.
PURPOSE: To determine the multiple-dose pharmacokinetic profile of topically administered Interferon alpha-2b Cream in women presenting with a cytological diagnosis of Pap IIID and of confirmed HPV+ status when the cream is applied consecutively for 27 days.
| Condition |
Intervention |
Phase |
| Cervical Dysplasia |
Drug: Interferon Alpha-2b Cream
Procedure: Intravaginal Application |
Phase II |
Study Type: Interventional
Study Design: Phase II study in symptom bearing subjects and is designed as open-label, single-arm study in 28 women.
Official Title: Mono-centre, open-label study to investigate the multi-dose pharmacokinetics, efficacy and safety of Interferon alpha-2b Cream in women with cytological diagnosis of Pap IIID and confirmed HPV+ status.
Start Date: March 2009
Clinical Sites: There is one clinical pharmacology unit and one clinical gynaecological centre participating in this study, being conducted exclusively in Germany.
Detailed Description:
OBJECTIVES:
Primary Endpoints:
Pharmacokinetic:
- Systemic levels of interferon alpha-2b: maximum concentration (Cmax)/time point of Cmax (tmax), Area Under the Curve (AUC):
Achievement of steady-state will be assessed by linear regression of the last three predose concentrations (slope = 0)
Secondary Endpoints:
Efficacy:
- Proportion of subjects whose Pap smear resolves from Pap IIID to Pap II or I confirmed by histology after end of treatment
Safety:
- Evaluations of safety and tolerance will be performed with all subjects of the safety population and, if possible, descriptively related to PK results
OUTLINE (TRIAL DESIGN): This is a mono-centre, open-label study. Only female patient treatment groups. The study drug, Interferon alpha 2-b Cream, is a preparation of interferon alpha-2b for intravaginal application based on Helix’s proprietary Biphasix™ drug formulation technology.
All patients will apply study cream intravaginally before bed every two days except during menstruation. Patients will apply a total of 35 doses over approximately 3 menstrual cycles or 10 to 12 weeks.
PROJECTED ACCRUAL: A total of 28 patients were originally to be enrolled in the study. On February 12, 2010, Helix announced that it intended to conclude patient recruitment for this study once a total of twelve patients complete the pharmacokinetic analyses.
Eligibility
Inclusion Criteria:
Pre-menopausal, non-pregnant females, 18 Years to 45 years of age
Cytological diagnosis of Pap IIID (Munich nomenclature II)
Mild cervical dysplasia (CIN I) or moderate cervical dysplasia (CIN II) confirmed by histology
HPV+ status confirmed by Hybrid Capture® 2 HPV Deoxyribonucleic Acid (DNA)-Test (Digene®)
HPV+ status confirmed by Hybrid Capture® 2 HPV Deoxyribonucleic Acid (DNA)-Test (Digene®)
Subjects must be on stable hormonal contraception, which guarantees 29 consecutive days without menstruation
Exclusion Criteria:
Cytological diagnosis other than Pap IIID
Severe dysplasia (CIN III), carcinoma in situ or invasive carcinoma
History of abnormal Pap smears higher than Pap IIID
History of or current internal or external urogenital warts
History of frequently recurrent or current sexually-transmitted infection(s) or bacterial vaginosis
History or presence of other malignancies
History or presence of other malignancies
Any other treatment of the cervical lesion during study participation (e.g. conization, laser ablation)
DISEASE CHARACTERISTICS: In most patients cervical cancer develops from Cervical Intraepithelial Neoplasias (CIN) grade I – III over a period of at least ten years. The incidence of these preliminary stages has continuously increased in Western Europe and the USA during the last two decades. Predominantly women at reproductive age (with a peak around 35 years) are concerned (Schneider et al., 2000).
At present, there is no immediate therapy available for women presenting with Pap IIID. The general consensus is that these patients are closely monitored without treatment every three months (Pap smear and colposcopy) and if abnormal Pap IIID persists or even worsens to Pap IV invasive treatment options such as cryotherapy or laser excision, and in more advanced cases Loop Electrosurgical Excision Procedures (LEEP) or cervical conization are applied.
Investigators
Medical Advisor and Gynecological Assessor:
Professor Achim Schneider M.P.H.
Charité Universitätsmedizin Berlin,
Klinik für Gynäkologie
Principal Investigator/LKP:
Dr. med. Alla Radicke
PAREXEL International GmbH
Klinikum Westend
More Information
Publications of Results: Not Available
Study ID Numbers:
Protocol Code Number: IFN005
EudraCT Number: 2008-006208-52
For more information or potential participation, please contact:
PAREXEL International GmbH
Klinikum Westend
Spandauer Damm 130, 14050 Berlin, Germany
www.paraxel.com
tel +49 (0)30 30685 -0
fax +49 (0)30 30685 -299