Navigation Links
Tumor-Targeted Rexin-G Prolongs Survival in Gemcitabine-Resistant Metastatic Pancreas Cancer in Advanced Phase I and II Studies (ASCO 2010)
Date:5/24/2010

SAN MARINO, Calif., May 24 /PRNewswire/ -- Epeius Biotechnologies Corporation (www.epeiusbiotech.com) today announces the results of the clinical study entitled "Phase I and II Studies of Intravenous Rexin-G as Monotherapy for Gemcitabine-resistant Metastatic Pancreas Cancer" at the ASCO Annual Meeting on June 6, 2010. The presentation will be discussed by Dr. Howard W. Bruckner, Bruckner Oncology, New York, NY.

STUDY SUMMARY: The goals of the Phase I/II study were to evaluate the overall safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in gemcitabine-resistant pancreas cancer. A Phase II "run in" study was integrated by adaptive design wherein additional cycles were given if the patient had Grade 1 or less toxicity. Twenty patients received escalating doses of Rexin-G intravenously three times a week for four weeks. Analysis of safety showed no dose-limiting toxicity and no cumulative toxicity in patients treated up to 18 months. Analysis of efficacy in evaluable patients revealed significant tumor responses:  100% tumor control rate (TCR) was observed at all doses tested, and 24% partial response (PR) or complete response (CR) by RECIST criteria in the high dose cohorts. A dose-dependent relationship between overall survival and Rexin-G dosage was demonstrated, which was significant at the 5% statistical level by log rank test (p = 0.03). Median survival was 9.3 months and one-year survival was 33% in the high dose groups. Remarkably, one patient exhibited a complete response with the (adaptive) repeated cycles, attaining clinical remission after 9 months of continued treatment with Rexin-G. These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity and that Rexin-G controls tumor growth and may prolong over-all survival in a dose-dependent manner in patients with gemcitabine-resistant pancreas cancer.                          

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation (www.epeiusbiotech.com) is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems. To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.  

*(LOGO 72dpi: www.send2press.com/mediaboom/10-0504-epeiusbio_72dpi.jpg)

This release was issued on behalf of the above organization by Send2Press(R), a unit of Neotrope(R). http://www.Send2Press.com


'/>"/>
SOURCE Epeius Biotechnologies
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Metastatic Pancreatic Cancer
2. Epeius Biotechnologies Tumor-Targeted Rexin-G Receives FDA Orphan Drug Designation for the Treatment of Osteosarcoma
3. Tumor-Targeted Nanoparticle-based Gene Delivery Provides Evidence of Therapeutic Vaccination in Patients with Metastatic Cancer (ASCO 2010)
4. FDA Grants Epeius Biotechnologies Rexin-G a Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas
5. Epeius Biotechnologies Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal
6. Rexin-G Returns to The Big Apple: Clinical Trials for Pancreatic Cancer and Breast Cancer Open in Manhattan
7. REXIN-G Shrinks Metastatic Tumors and Triples Survival Time in Chemotherapy-Resistant Pancreatic Cancer: Analysis of a U.S. Phase I/II Clinical Trial (Proceedings of ASCO GI Symposium 2009)
8. Beginners Luck, or Creative Artists of the First Rank? Epeius Biotechnologies Launches Rexin-G eBook Tutorial
9. The Worlds Smallest Hero! Rexin-G, Targeted Therapy for Metastatic Cancers
10. Epeius Biotechnologies Corporation Expands its Rexin-G Production Facilities in Southern California
11. PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... SILVER SPRING, Md. , June 23, 2016 ... evidence collected from the crime scene to track the criminal ... sick, and the U.S. Food and Drug Administration (FDA) uses ... Sound far-fetched? It,s not. ... whole genome sequencing to support investigations of foodborne illnesses. Put ...
(Date:6/23/2016)... --  EpiBiome , a precision microbiome engineering company, today ... from Silicon Valley Bank (SVB). The financing will allow ... drug development efforts, as well as purchase additional lab ... been an incredible strategic partner to us – one ... provide," said Dr. Aeron Tynes Hammack , EpiBiome,s ...
(Date:6/23/2016)... 23, 2016  Blueprint Bio, a company dedicated to ... medical community, has closed its Series A funding round, ... "We have received a commitment from Forentis ... need to meet our current goals," stated Matthew ... runway to complete validation on the current projects in ...
(Date:6/23/2016)... ... 2016 , ... Velocity Products, a division of Morris Group, ... exclusively for Okuma CNC machining centers at The International Manufacturing Technology Show, IMTS, ... companies with expertise in toolholding, cutting tools, machining dynamics and distribution, Velocity SMART ...
Breaking Biology Technology:
(Date:6/22/2016)... 2016 On Monday, the Department of Homeland ... share solutions for the Biometric Exit Program. The Request ... Protection (CBP), explains that CBP intends to add biometrics ... the United States , in order to deter ... Logo - http://photos.prnewswire.com/prnh/20160622/382209LOGO ...
(Date:6/9/2016)... leader in attendance control systems is proud to announce the introduction of fingerprint attendance ... the right employees are actually signing in, and to even control the opening of ... ... ... Photo - ...
(Date:6/2/2016)... NEW YORK , June 2, 2016   The ... (Weather), is announcing Watson Ads, an industry-first capability in which ... advertising, by being able to ask questions via voice or ... Marketers have long ... with the consumer, that can be personal, relevant and valuable; ...
Breaking Biology News(10 mins):