Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical stage biotherapeutics company developing a proprietary breakthrough product class of targeted oncolytic virus therapeutics, today announced that the European Medicines Agency (EMEA) has granted Orphan Drug Designation to Jennerex's product JX-594 for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. JX-594 is expected to enter a Phase 3 pivotal trial in the second half of 2010.
European Orphan Drug Designation encourages the development of products that demonstrate promise for the treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union. The designation criteria also specify that there is no other satisfactory therapy for that indication and that if JX-594 is shown to be effective in pivotal trials, it would represent a significant clinical benefit to HCC patients. Orphan Drug status for JX-594 entitles Jennerex to 10 year market exclusivity in Europe if the Market Authorization Application (MAA) is approved as well as potentially increasing reimbursement pricing. The designation also confers special benefits, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees during development or at the time of application for marketing approval.
"This designation is an important step in the development of a potential breakthrough treatment for this lethal disease," said David H. Kirn, M.D., President and Chief Executive Officer of Jennerex. "We look forward to working closely with the European regulatory authorities to complete the global development of JX-594 for the treatment of primary liver cancer."