ISA Pharmaceuticals announces NEJM publication on VIN phase II data

November 11, 2009

New England Journal of Medicine Publishes a highly Successful Clinical Study by Leiden University Medical Center and ISA Pharmaceuticals B.V. with a therapeutic HPV vaccine in patients with premalignant vulvar lesions

SLP®-based therapeutic HPV vaccine to enter phase III clinical trials

ISA Pharmaceuticals B.V., the Dutch clinical stage biopharmaceutical company focusing on the development of therapeutic vaccines, and Leiden University Medical Center (LUMC), announced today that the New England Journal of Medicine has published positive results from a clinical phase II study with the Synthetic Long Peptide (SLP®)-based therapeutic vaccine to treat patients with Human Papilloma Virus induced neoplasia (SLP-HPV-01). Vaccination of patients with high-grade Vulvar Intraepithelial Neoplasia (VIN3) with SLP®-HPV-01 resulted in an 75% objective clinical response rate.

VIN3, a high grade precursor stage of vulvar cancer, is caused by the Human Papilloma Virus (HPV). In this study, patients were injected subcutaneously with SLP®-HPV-01. By inducing a robust HPV specific immune response, ISA’s SLP®-HPV-01 vaccine was shown to induce an unprecedented high number of objective complete clinical responses, persisting for at least 24 months after treatment. The breakthrough is the use of synthetic long peptides. This ‘synthetic long peptide concept (SLP®)’ enables the activation of both cytotoxic T-cells (‘killer cells’) and T-helper cells, as a result of superior activation of the immune system. This phase II study is the first to document robust therapeutic activity with a vaccine for HPV and is an important step towards treatment of this devastating disease, for which as yet no successful standard therapy is available. Following this clinical proof-of-mechanism, ISA has started preparations for a phase III clinical study. In addition to its’ lead VIN program for which ISA obtained the orphan drug designation, the HPV-SLP® vaccine is under clinical evaluation in three additional HPV-induced disease indications among which is cervical cancer.



Gerard Platenburg, Chief Executive Officer of ISA, commented: "This first clinical phase II study successfully demonstrates that the therapeutic HPV-SLP®-vaccine, based on ISA’s proprietary SLP® technology, was able to induce a good clinical response in VIN3 patients. We are excited to have demonstrated clinical proof-of-mechanism and are progressing SLP®-HPV01 into Phase III trials in order to assess the broader benefits available to patients. SLP®-based vaccines hold great promise as an approach to create a novel class of exciting synthetic medicines and we are well positioned to exploit this opportunity.”



Professor dr. Gemma Kenter, together with her colleagues Prof.dr. Cornelis Melief and Dr. Sjoerd van der Burg, of the LUMC commented: “After more than 10 years of preparatory work we were greatly rewarded by this clinical effect. The statistically significant correlation between the immunological response and the clinical effect is unique in therapeutic vaccination strategies and it creates an excellent starting point for further expansion of activities. Not only with respect to the treatment of HPV-induced diseases but also with similar type of vaccines for other types malignancies or chronic infections”



Professor Olivera Finn, one of the pioneers of cancer immunology and president of the American Association of Immunologists, remarked in a commenting editorial that “the paper by Kenter et al. might herald the dawn of effective therapeutic vaccines”.



Contact details: Gerard Platenburg, CEO, platenburg@isa-pharma.com

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