OXIGENE ANNOUNCES POSITIVE RESULTS FROM TUMOR TREATMENT STUDY

OxiGene announced it has completed a Phase II study in patients with advanced malignancies. This was a randomized, open-label study of intravenous combretastatin A-4 phosphate (CA4P) administered at 45 or 63 mg/m2 followed by paclitaxel and carboplatin in 13 patients. The objectives of the trial were to identify optimal dose of CA4P for blood-flow shutdown and to demonstrate safety and efficacy of CA4P in combination with paclitaxel and carboplatin. All patient data have been collected and analyzed, with the exception of one patient who is still continuing in the optional extension phase of the protocol due to continued good clinical response.

Top-line data from the study indicate that the objectives of the study were met. The imaging confirmed blood-flow shutdown in a wide variety of advanced malignancies, and safety data is in line with expectations and tumor responses were seen in multiple patients.

Despite advances in the management of cancer with radiotherapy, chemotherapy and surgery, there is an unmet medical need for treatments with new mechanisms of action, which may act synergistically with chemotherapy and radiotherapy, according to the company. Tumor vasculature has become a relatively recent target in the development of new cancer therapies, with the focus aimed primarily on compounds that prevent the formation and growth of new blood vessels (i.e., anti-angiogenesis therapy).

CA4P is a novel anticancer agent that has displayed potent and selective toxicity toward tumor vasculature in clinical studies to date, the company said. The rationale for combining CA4P with other cytotoxic regimens stems from the hypothesis that agents with different and potentially complimentary mechanisms of action and with a non-overlapping toxicity profile may achieve synergistic antitumor activity when administered concurrently. CA4P has been shown to enhance and the antitumor effects of several chemotherapeutic agents and radiation in animal studies, according to OxiGene.