The Phase II trial involves treatment of patients with advanced, primary liver cancer refractory to standard therapies. Patients are randomized to receive treatment at one of two dose levels. The 30-patient, multi-national trial is being conducted at clinical sites in the US, South Korea and Canada.
The primary objective for this trial is to study the efficacy of treatment with JX-594 at two different dose levels in preventing tumor progression, as measured by modified RECIST criteria at eight weeks from initiation of treatment in patients with unresectable primary hepatocellular carcinoma.
In addition, safety and tolerability, as well as tumor response and progression-free survival, of JX-594 administered at the two dose levels will be evaluated. Up to 30 total patients will be treated.
Jennerex has also announced an alliance with Rex Medical, a manufacturer of advanced multi-pronged needles, for the targeted intratumoral administration of JX-594. Jennerex shall exclusively use Rex Medical Quadra-Fuse needles for intratumoral injections of JX-594 in clinical development, and Rex Medical shall work collaboratively with Jennerex to effectively apply this technology to JX-594 clinical development.
David Kirn, president and CEO of Jennerex, said: We’re very excited to have this trial open and enrolling with our lead product, JX-594, which has the potential to revolutionize the treatment of the more than 10,000 patients each year who develop liver cancer in the US alone. The numbers of patients with liver cancer in the EU, Japan and Asia are even higher. These desperate patients represent a huge unmet medical need since few effective therapies are available for them.