Navigation Links
Jennerex Reports Positive Phase 1 Results for JX-594 Administered Intravenously
Date:5/20/2010

SAN FRANCISCO and WASHINGTON, May 20 /PRNewswire/ -- Jennerex, Inc., a clinical-stage cancer biotherapeutics company, today reported positive results from its Phase 1 dose escalation study evaluating the intravenous (IV) administration of JX-594 to patients with metastatic cancer.  The data presented today demonstrated clear dose-related delivery to solid tumors, cancer-targeted replication and gene expression, and anti-cancer effects of JX-594 delivered IV.  Choi (necrotic) responses were more commonly observed in patients treated at higher doses.  In addition, intravenous infusion of JX-594 was safe and well-tolerated.  These data were presented today at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in Washington DC.

"These data represent a significant milestone for the field of oncology and viral therapy as this is the first time that a viral or genetic product has demonstrated reproducible, biopsy-proven delivery to multiple solid tumor types following intravenous administration," said David H. Kirn, M.D., president and chief executive officer of Jennerex.  "We look forward to extending our experience with IV JX-594 in our planned Phase 3 trial in patients with advanced liver cancer.  This pivotal trial will utilize both IV and targeted intratumoral injections of JX-594 to maximize potential patient benefit.  We expect to initiate this study in Q4 of 2010."

"JX-594 represents a promising potential treatment option for patients with multiple types of cancer.  As the first intravenous biological immunotherapy to demonstrate safety and tumor-specific delivery, JX-594 may add significantly to the armamentarium for many solid tumors," stated Andrew R. Haas, M.D., Ph.D., Hospital of the University of Pennsylvania, and investigator on JX-594 Phase 1 trial.

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.  Six out of eight patients in the higher-dose cohorts evaluable to date (cohorts 3, 4, 5) exhibited disease control as defined by stable disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria and/or Choi (necrotic) response.  Two out of six patients in the low dose cohorts exhibited disease control (RECIST stable disease) but no responses.  The primary endpoints of the trial included safety and determination of the maximum tolerated dose given through intravenous administration.  No serious adverse events related to JX-594 therapy were reported and no dose-limiting toxicities were reported.  A biomarker analysis further strengthened the finding of dose-dependent replication in tumors following IV administration.

About JX-594

JX-594, currently in Phase 2 clinical trials for liver cancer, 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.

About Jennerex

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 research and development operations in Ottawa, Canada and Busan, South Korea.  For more information about Jennerex and the Company's pipeline of three clinical-stage products, please visit www.jennerex.com .


'/>"/>
SOURCE Jennerex, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Jennerex Appoints Bob Ingram Special Advisor and Hires Marty Glick as EVP, Corporate Strategy
2. Jennerex Completes $8.3 Million Series B Financing and Appoints Dr. Cal Stiller as Director
3. Jennerex Appoints Samantha Miller as Vice President of Corporate Development
4. Nature Reviews Publishes Article About Jennerexs Multi-Mechanistic Cancer Therapeutic
5. Jennerex Closes $5 Million First Tranche of Series C Financing
6. Jennerex Completes Over-Subscribed Series C Financing for Aggregate Gross Proceeds of Over $5.5 Million
7. Jennerex Adds Industry Veteran Paul Cleveland to Board of Directors
8. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
9. QMed, Inc. Reports July Medicare SNP Enrollments
10. Phlo Affiliate Reports Expanded Coverage to Oregon Border
11. Healthcare Technologies Reports Loss for 2007 Second Quarter & Six Months Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2017)... (PRWEB) , ... August 20, 2017 , ... ... Journal of Biomedical Optics (JBO) starting 1 January 2018. The journal is published ... Biomedical Optics publishes papers on the use of modern optical technology for improved ...
(Date:8/21/2017)... ... August 21, 2017 , ... The team at ... webinar, in which attendees will learn about the assembly and topological architecture of ... an overview of the development and validation of new high-quality recombinant monoclonal antibodies, ...
(Date:8/17/2017)... ... August 17, 2017 , ... ... and personalized medicine, today announced the launch of a new breast cancer monitoring ... study’s goal is to evaluate the potential for early detection of recurrent breast ...
(Date:8/16/2017)... ... August 16, 2017 , ... Today, 3Bar ... has secured $2M in funding from an impressive group of investors, including Rev1 ... Thrive Fund. With this investment, 3Bar is broadening availability of its groundbreaking offering ...
Breaking Biology Technology:
(Date:4/3/2017)... 2017  Data captured by IsoCode, IsoPlexis ... a statistically significant association between the potency ... and objective response of cancer patients post-treatment. ... whether cancer patients will respond to CAR-T ... as to improve both pre-infusion potency testing and ...
(Date:3/29/2017)... 29, 2017  higi, the health IT company that ... North America , today announced a Series B ... of EveryMove. The new investment and acquisition accelerates higi,s ... to transform population health activities through the collection and ... higi collects and secures data today on behalf ...
(Date:3/24/2017)... Research and Markets has announced the addition ... Trends - Industry Forecast to 2025" report to their offering. ... The Global Biometric ... of around 15.1% over the next decade to reach approximately $1,580 ... market estimates and forecasts for all the given segments on global ...
Breaking Biology News(10 mins):