In addition to the 10-year market exclusivity, incentives relating to the designation include assistance from the European Medicines Evaluation Agency in developing a protocol to maximize the chance of success in achieving market authorization.
Protox is on target to initiate a pre-pivotal Phase IIb clinical trial of PRX321 in the second half of 2008, for the treatment of recurrent glioblastoma multiforme, a fatal form of brain cancer.
PRX321 is a novel targeted protein in which a cytokine, interleukin-4 (IL-4), is linked to a Pseudomonas exotoxin, a potent substance that selectively kills cancer cells. A single treatment of PRX321 has demonstrated promising signs of therapeutic activity in patients with highly aggressive forms of brain cancer in clinical studies performed at centers in the US and Germany, said the company.