SAN FRANCISCO and YONGIN, South Korea, Jan. 12 /PRNewswire/ -- Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), and its South Korean partner Green Cross Corp., today announced treatment of the first five patients in a Phase 2 primary liver cancer clinical trial using its targeted and armed poxvirus JX-594. No significant toxicities were reported, and enrollment of patients onto the trial is continuing.
The Phase 2 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 United States, South Korea and Canada.
"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 U.S. 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," said David H. Kirn, M.D., President and Chief Executive Officer of Jennerex.
"We have already treated four patients with JX-594 in Korea and are anxious to see the efficacy of JX-594 in these late stage liver cancer patients," said B.G. Rhee, Ph.D., Executive Vice President of Green Cross.
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.
New Alliance for Use of Quadra-Fuse, Multi-pronged Injection Needles
Jennerex also announced today 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 ("QF 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.
"We are excited to be collaborating with Rex Medical, the market leader in this field, for application of Quadra-Fuse needle technology with JX-594. This is the first needle designed for optimizing therapeutic delivery of fluids/agents into target tissue zones. This innovative multi-pronged design allows us to precisely target distribution of JX-594 for optimal therapeutic effect. The result is an innovative and potentially landmark combination of a highly targeted biotherapeutic agent with a sophisticated medical device for targeted delivery," stated Dr. Kirn.
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 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.
About Green Cross Corporation
Green Cross is a leader in the Korean biotechnology and pharmaceutical industries. Green Cross is now an internationally recognized biotechnology company developing several vaccines and therapeutic proteins. Green Cross will become the only seasonal influenza vaccine manufacturer in South Korea and also is developing avian influenza vaccine. In its vaccine business, Green Cross has successfully developed one of the earliest vaccines against Hepatitis B (Hepavax), the first Epidemic Hemorrhagic Fever vaccine and the world's second chicken pox vaccine. Green Cross is developing recombinant Factor VIII and Factor IX for hemophilia, Hepatitis B Immunoglobulin monoclonal antibody for liver transplantation, anticancer drugs such as Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF for neutropenia. For more information about Green Cross, please visit http://www.greencross.com.
About Rex Medical
Rex Medical, LP, based in Conshohocken, Pennsylvania, is a privately held medical device company specializing in the development, manufacturing and marketing of minimally invasive medical devices targeted towards the oncology, cardiovascular, venous access, and endosurgery markets.
|SOURCE Jennerex, Inc.|
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