The US Department of Defense, Army Medical Research and Materiel Command has awarded the University of Chicago School of Medicine a $1.1 million grant for the first clinical trial of squalamine in the treatment of prostate cancer.
The grant, entitled "Neoadjuvant Anti-Angiogenesis Therapy for Prostate Cancer," will support a phase II clinical trial. The trial is designed as an open-label randomized study to evaluate the activity and tolerability of squalamine in conjunction with anti-androgen therapy in patients undergoing radical prostatectomy.
Up to 132 patients will receive weekly dosing of squalamine (100mg/m2) for either 6 or 12 weeks. The trial is expected to commence in the near-term after required clinical administrative initiation procedures are completed.
"The study design was suggested by our preclinical results with squalamine. The use of medications prior to prostate cancer surgery has not been fully explored, and squalamine anti-angiogenic therapy combined with androgen ablation is a promising approach. We are targeting a population of men with prostate cancer who are at increased risk of recurrence after either surgery or radiation," commented Dr Mitchell H Sokoloff, lead investigator for the trial, in a media release.
Squalamine is the first clinical drug candidate in a class of naturally occurring, pharmacologically active, small molecules known as aminosterols. Squalamine is a potent anti-angiogenic molecule with a unique multi-faceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor (VEGF).