Date: 2013-09-16
Type of information:
phase: 1-2
Announcement: initiation of the trial
Company: ISA Pharmaceuticals (The Netherlands)
Product: ISA101
Action mechanism: ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus type 16 (HPV16), such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.
Disease: anal intraepithelial neoplasia (AIN)
Therapeutic area: Cancer - Oncology - Infectious diseases
Country: The Netherlands
Trial details: The open-label, dose-response study will be conducted in 30 HIV-positive male patients suffering from HPV16-positive high-grade AIN, who failed previous treatment. In the first dose escalation part of the trial, patients will be vaccinated with ISA101 in three dosing cohorts three times at three-week intervals, either with or without administration of peg-interferon-? on the day of vaccination. An additional group of 15 patients will be treated with the optimal ISA101 schedule. Primary clinical endpoints will be toxicity and safety as well as regression of lesions at 3, 6 and 12 months. Secondary endpoints are regression of lesions at 18 months and HPV16-specific immunity in the blood.
Latest
news: * On September 16, 2013, ISA Pharmaceuticals, a clinical-stage biopharmaceutical company focusing on rationally designed, fully synthetic therapeutic vaccines against cancer and persistent viral infections, has announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in HIV-positive men suffering from anal intraepithelial neoplasia (AIN). The study is supported by ZonMw, the Dutch Organisation for Health Research and Development, and is being conducted in The Netherlands.“It is the first of two clinical trials of our lead product that we are initiating this year. The current trial will also specifically assess a novel, standardized intradermal injection route together with interferon-? administration, said Jan Fagerberg, CMO of ISA Pharmaceuticals. We expect first results from this trial in 2014.” Another SLP® vaccines is currently in clinical development: ISA102, targeting p53-overexpressing tumors.
