ISA Pharmaceuticals Initiates Phase I/II Clinical Trial With ISA101 in Women With Cervical Cancer
Leiden, The Netherlands, October 29, 2013 – ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in women with HPV16-positive advanced or recurrent cervical cancer, eligible for standard chemotherapy with carboplatin and paclitaxel (CervISA study). The first patient was vaccinated this month.
ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus (HPV) type 16, such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.
The open-label, multicenter CervISA study is designed to determine the safety and immune-modulating effects of ISA101 at different doses with or without pegylated interferon alpha in combination with carboplatin and paclitaxel.
Patients will receive up to six standard chemotherapy cycles (paclitaxel 175 mg/m2 and carboplatin AUC 6 every three weeks) and three vaccinations at different dose levels during the same period. Half the women at each dose level will also receive pegylated interferon alpha. Primary endpoints of the trial are safety and HPV-specific immune responses. The secondary endpoint is antitumor efficacy according to RECIST 1.1.
Virtually all cervical cancers are caused by HPV infections, with HPV16 being responsible for about 50-60% percent of all cases.
“This is the second trial that we have initiated with our lead product this year,” said Jan Fagerberg, Chief Medical Officer of ISA Pharmaceuticals. “In this trial, we are exploring ISA101 with or without interferon in combination with chemotherapy. We expect increased and more robust immunological responses against HPV16, hopefully leading to improved clinical efficacy as compared to chemotherapy alone. We have already seen synergies between SLP vaccinations and chemotherapy in HPV16 animal tumor survival models. Moreover, after treatment with carboplatin-paclitaxel, stronger specific T-cell responses after vaccination with ISA101 have been observed in a pilot study in women with cervical cancer.”
About ISA Pharmaceuticals
ISA Pharmaceuticals B.V. is a biopharmaceutical company developing rationally designed, fully synthetic therapeutic vaccines against cancer and persistent viral infections. The company has built a proprietary vaccine platform based on the Synthetic Long Peptide (SLP®) and AMPLIVANT technologies, which permit the generation of safe and effective vaccines with a known mechanism of action. SLP® vaccines are broadly applicable to multiple targets and ideally suited as monotherapy or as essential components in combination with conventional cancer treatments.
Two SLP® vaccines are currently in clinical development: ISA101, targeting human papillomavirus (HPV) induced diseases, and ISA102, targeting p53-overexpressing tumors. Clinical proof-of-concept has been established with ISA101 in vulvar intraepithelial neoplasia (VIN), a pre-cancerous disease caused by HPV.
The company was founded in 2004 by Aglaia Oncology Fund and is based in Leiden, The Netherlands. For more information, please visit www.isa-pharma.com
About ISA101
ISA101, the lead product of ISA Pharmaceuticals, is an SLP® vaccine for the treatment of HPV16-induced diseases, including cervical cancer, most ano-genital premalignant and malignant lesions, and head and neck cancer. Among others, it has been tested in women with vulvar intraepithelial neoplasia (VIN). In this study, ISA101 was well tolerated, and proved to be clinically effective with complete or partial regression of lesions in patients with high-grade VIN. Clinical response was strongly associated with the induction of a robust and broad HPV16-specific immune response.
ISA101 is currently being tested in combination with chemotherapy in a Phase I/II clinical trial in women with cervical cancer (CervISA study) and in a Phase I/II clinical trial in HIV-positive male patients suffering from high-grade intra-anal intraepithelial neoplasia.
The vaccine has been granted Orphan Drug Designation by the EMA (2007) and the FDA (2011) for the treatment of HPV-positive VIN.
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