OxiGene begins phase I novel anticancer trial

OXi4503 has been shown in animals to have potent anti-tumor activity as both a single-agent and in combination therapy. This phase I trial propels OxiGene forward into the clinical development of two distinct technology platforms, resulting in a total of ten clinical trials in oncology and ophthalmology.

OXi4503 is the lead compound in a novel class of agents OxiGene has termed ortho-quinone prodrugs (OQPs). OXi4503 is novel in that it exhibits not only vascular disrupting properties, as with the company’s lead vascular targeting agent, CA4P, but can also cause direct cytotoxicity to tumor cells.

As the compound is a first in class of this type of agent, the phase I trial will gather further information on the compound’s mechanism of action, as well as safety data.

The planned study, to be run by Cancer Research UK, will be a dose escalating trial in which the primary endpoints are safety, tolerability and pharmacokinetics. Although ostensibly a phase I safety study, the protocol design has incorporated advanced testing to monitor patients through extensive blood work, MRI and PET scans.

“This phase I trial with OXi4503 is an excellent addition to our already strong clinical development program and represents a significant step forward for the company,” said Fred Driscoll, president and CEO of OxiGene. “We believe that OXi4503 promises to complement and strengthen our clinical program by expanding upon the indications and therapeutic regimes already under investigation. We anticipate advancing the compound into phase II trials in 2006.”