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:5/16/2017)... ... (PRWEB) May 16, 2017 , ... ... Orthopaedic Surgeons (CAOS), long-standing development partners Invibio Biomaterial Solutions, UK, and China’s ... workshop to help expand knowledge of the implantation of Double Medical’s Direct ...
(Date:5/15/2017)... N.J. (PRWEB) , ... May 15, 2017 , ... ... delivery technologies and development solutions for drugs, biologics and consumer health products, today ... company focused on rare genetic diseases, to support preclinical and clinical development of ...
(Date:5/15/2017)... May 15, 2017  IBM (NYSE: IBM ) ... stretch double-stranded DNA molecules with the potential to ... This technology complements the IBM Research,s "lab-on-a-chip" ... as exosomes and which may also contain biomarkers ... an array of diamond shaped micropillars 1 ...
(Date:5/11/2017)... May 11, 2017   BioLife Solutions , Inc. (NASDAQ: ... of proprietary clinical grade cell and tissue hypothermic storage ... "Company"), today reported operational highlights and financial results for the ... product sales reached a new high of $2.4 million in ... the same period in 2016. Revenue growth was driven by ...
Breaking Biology Technology:
(Date:4/17/2017)... Florida , April 17, 2017 NXT-ID, ... technology company, announces the filing of its 2016 Annual Report on ... and Exchange Commission. ... on Form 10-K is available in the Investor Relations section of ... as on the SEC,s website at http://www.sec.gov . ...
(Date:4/11/2017)... Research and Markets has announced the addition ... their offering. ... tracking market to grow at a CAGR of 30.37% during the ... 2017-2021, has been prepared based on an in-depth market analysis with ... its growth prospects over the coming years. The report also includes ...
(Date:4/5/2017)... -- The Allen Institute for Cell Science today announces the ... and dynamic digital window into the human cell. The ... of deep learning to create predictive models of cell ... growing suite of powerful tools. The Allen Cell Explorer ... available resources created and shared by the Allen Institute ...
Breaking Biology News(10 mins):