Jennerex, Inc 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 tumours 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, 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 tumour 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.
Jennerex'sJX-594 is a cancer biotherapeutic, currently in phase-II trials, from a proprietary class of targeted and armed oncolytic poxviruses.
Jennerex is a clinical-stage biopharmaceutical company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer.