SAN FRANCISCO, Oct. 19 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."
About Hepatocellular Carcinoma
The treatment of advanced hepatocellular carcinoma represents a significant unmet medical need. HCC is responsible for about 90 percent of the primary malignant liver tumors in adults. Most cases of HCC are secondary to either a viral hepatic infection (hepatitis B or C) or cirrhosis (alcoholism being the most common cause of hepatic cirrhosis). The usual outcome for patients is poor, because only 10 to 20 percent of hepatocellular carcinomas can be removed completely using surgery. If the cancer cannot be completely removed, the disease is usually deadly within three to six months.
Jennerex is a clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The Company's lead product JX-594, currently in an international randomized Phase 2 clinical trial for patients with primary liver cancer, demonstrated promising Phase 1 efficacy and safety results in patients with a diverse array of common cancers. Jennerex's products target, attack and eradicate cancers through a novel and potent oncolytic mechanism that is dependent on highly-specific replication of the Company's poxviruses in cancer cells. These products not only cause cancer cell lysis thereby killing through replication, they simultaneously shut-off the blood supply to tumors, as well as stimulating the body's immune response to the cancer. Jennerex, Inc. is headquartered in San Francisco and has manufacturing and research activities based at the Ottawa Hospital Research Institute in Ottawa, Canada. For more information about Jennerex and the Company's pipeline of three clinical-stage products, please visit www.jennerex.com.
SOURCE Jennerex, Inc.