Datapharm has conducted a number of first-in-man (Phase 0) studies from the first gene therapy study referred to GTRAP in the mid 90s, targeted intra-arterial and delivery vehicle studies and most recently intratumoural injections of a DNAzyme. These new and innovative treatment strategies needed careful planning and implementation to see each project to successful completion.
Datapharm has experience in Phase 1/II studies of prostate cancer therapies, melanoma treatments, haematological malignancies and glioblastoma multiforme. These are typically dose finding studies often requiring a PK component. Datapharm has assisted with Phase II clinical studies of breast and ovarian cancer, cancers of bowel and blood and a large international Phase III clinical trial using antisense material in the treatment of CLL. This was an important and successful study allowing our client to proceed to final registration of the product.
Datapharm also has Phase IV (post-marketing) oncology experience, having conducted a long-running study into the use of isoflavones to treat prostate cancer.
Currently Datapharm is building its clinical trial network of Melanoma specialists for both early and late phase clinical trials in Australia and New Zealand.