SAN FRANCISCO, April 13 Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), a clinical-stage cancer biotherapeutics company, today announced that it has completed patient enrollment in a Phase 1 clinical trial evaluating the intravenous (IV) administration of JX-594, the company's lead product for the treatment of solid tumors. Jennerex expects to report the results from this trial at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in May 2010.
"Enrollment on this trial is now complete. We plan to report results from this trial in the near future showing that JX-594 can be safely and effectively delivered to metastasized tumors through intravenous administration," said David H. Kirn, M.D., president and chief executive officer of Jennerex. "We intend to use the optimized IV dose in our planned Phase 3 study that will evaluate the efficacy of both intratumoral and IV administration of JX-594 for the treatment of liver cancer scheduled to begin in the second half of 2010. In addition, we will use this IV dose in a Phase 2 trial in colorectal cancer."
This open-label, dose-escalation study was completed at four sites in the United States and Canada. A total of 23 patients with solid tumors refractory to standard therapy were enrolled. Patients received a single treatment at one of five dose levels, with follow-up at periodic intervals. The primary endpoints of the trial included safety and determination of the maximum tolerated dose given through intravenous administration. A biomarker analysis predictive of viral replication in distant tumors is also being conducted.
JX-594, currently in Phase 2 clinical trials, is a cancer biotherapeutic product from a proprietary breakthrough class of targeted and armed oncolytic and immunotherapeutic poxviruses. Tumor destruction and safety was shown in patients with diverse cancer types in three Phase 1 trials; treated patients were end-stage and had no effective therapies available. JX-594 multiplies selectively within cancer cells, leading to their destruction. These newly created copies of JX-594 are then released and are able to infect and eradicate other tumor cells both locally and in distant sites in the body. This cycle of JX-594 replication, cancer cell destruction, release and spread is then repeated. Normal cells are not affected by JX-594 resulting in safety and tolerability.
The poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells. JX-594 was engineered to enhance this natural safety and cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. To enhance product efficacy, JX-594 is also engineered to express the GM-CSF protein. GM-CSF complements the cancer cell lysis work of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.
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.