Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial with Intravenous Delivery of JX-594 Oncolytic Virus
- Category: Vaccines
- Published on Wednesday, 15 October 2008 02:00
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12 Patient Trial Targets Advanced Solid Tumors, Including Lung Cancer
SAN FRANCISCO, CA, USA | Oct. 15, 2008 | Jennerex, Inc. (San Francisco, CA and Ottawa, Canada) today announced the completion of treatment for the first patient cohort in the Phase 1 cancer clinical trial of its targeted poxvirus JX-594, delivered by intravenous (IV) infusion. No significant toxicities were reported, and treatment was well-tolerated.
The Phase 1 IV trial involves treatment of patients with advanced, metastatic solid tumors refractory to standard therapy. Patients receive treatment at one of five dose levels in a sequential dose-escalating design; the first cohort has now been treated safely. Once the maximum tolerated dose is defined, an additional three to six patients will be enrolled at that dose level. The trial is being conducted initially at clinical sites in the United States, and will subsequently open at sites in Canada.
"We're very excited to have this trial open and enrolling with our lead product, JX-594. The safe delivery of JX-594 through intravenous administration is a major milestone for our Company," said David H. Kirn, M.D., President and Chief Executive Officer of Jennerex. "IV therapy allows treatment of major market cancers including non-small cell lung cancer. These data confirm the safety and feasibility of systemic dosing and tumor targeting that were reported in liver tumor patients treated previously."
The primary objective for this trial is to determine the maximum tolerated and/or feasible dose of JX-594 administered IV. In addition, IV delivery of JX-594 to solid tumors will be evaluated. An estimated total of 12 to 15 patients will be treated.
JX-594 is a cancer biotherapeutic product, currently in Phase 2 trials, from a proprietary breakthrough class of targeted and armed oncolytic poxviruses. Tumor destruction and safety was shown in patients with diverse cancer types on 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 Biotherapeutics was established in San Francisco and in Ottawa in 2006 with Dr. David Kirn (CEO) in San Francisco and Dr. John Bell (CSO) from the Ottawa Health Research Institute/University of Ottawa. Jennerex is a clinical-stage biopharmaceutical 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 Phase 2 trial for primary liver cancer, demonstrated promising Phase 1 efficacy and safety results in patients with a diverse array of common large market 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 simultaneously stimulate the body's immune response to the cancer. Of note, this mechanism of action and the results in patients to date put the company's product class in a leadership position. Jennerex's position is in marked contrast to gene therapy and standard cancer vaccine approaches. For more information about Jennerex and the company's robust pipeline and three clinical-stage products, please visit http://www.jennerex.com.