Navigation Links
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)
Date:1/20/2009

SAN MARINO, Calif., Jan. 20 /PRNewswire/ -- Epeius Biotechnologies (www.epeiusbiotech.com) announced the results of a U.S. Phase I/II study evaluating the safety and efficacy of Rexin-G in chemotherapy-resistant metastatic pancreatic cancer (ASCO GI Symposium, #249; Sant P Chawla, P.I., Santa Monica CA, January 2009). Rexin-G was well tolerated and there was no dose-limiting toxicity. At Dose Level I, three patients achieved stable disease with no tumor progression; and at Dose Level II, one patient had a 37% decrease in tumor size and five patients exhibited disease stabilization with no tumor progression. Importantly, Rexin-G improved patient survival in a dose-dependent manner: At Dose Level I, median progression-free survival was 3 months, and median over-all survival was 5 months, while at Dose Level II, median progression-free survival was greater than 3 months, and median over-all survival was greater than 9 months.

By direct comparison with a prior low-dose Phase I safety study (Galanis et al. 2008), the new "effective doses" of Rexin-G nearly tripled the overall survival time. Thus, this current Phase I/II study defines a critical pharmacological "threshold" for Rexin-G bioactivity in the treatment of metastatic pancreatic cancer. The present study confirms the overall safety of Rexin-G, and further demonstrates that Rexin-G monotherapy, at these defined dose levels, exhibits profound anti-tumor activity that prolongs both progression-free survival and over-all survival time in pancreatic cancer patients that had previously failed standard chemotherapy.

Rexin-G is the world's first and so far only targeted injectable genetic medicine that has been validated in the clinic (Nature Reviews/Genetics 2007). Injected intravenously, the targeted nanoparticles are designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body. The FDA has granted Orphan Drug Status for Rexin-G for the treatment of (i) pancreatic cancer, (ii) osteosarcoma, and (iii) soft tissue sarcoma, while the Philippine BFAD has granted accelerated approval of Rexin-G for the treatment of all solid tumors that are resistant to standard chemotherapy.

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its tumor-targeted gene delivery systems. To learn more about ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

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


'/>"/>
SOURCE Epeius Bio
Copyright©2009 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. FDA Grants Epeius Biotechnologies Rexin-G a Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas
4. Epeius Biotechnologies Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal
5. Rexin-G Returns to The Big Apple: Clinical Trials for Pancreatic Cancer and Breast Cancer Open in Manhattan
6. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
7. Center for Molecular Medicine One of the First Midwest Labs to Offer Advanced Test for Patients with Metastatic Breast Cancer
8. Kosans Hsp90 Inhibitor, Tanespimycin, Shows 55% Clinical Benefit in Patients With Trastuzumab-Refractory Metastatic Breast Cancer
9. Accelerated Community Oncology Research Network, Inc. (ACORN), Initiates a Phase 2b Metastatic Breast Cancer Trial in Cooperation With Bayer and Onyx
10. Oncothyreon initiates Phase 1b trial of PX-12 in patients with advanced metastatic cancer
11. NOTICE OF YM BIOSCIENCES CONFERENCE CALL TO DISCUSS PHASE II DATA FOR NIMOTUZUMAB IN METASTATIC COLORECTAL CANCER
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... 2016 , ... Franz Inc. , an early innovator ... announced the availability of AllegroGraph 6, the leading Semantic Graph Database with certification ... Program (CCPT). AllegroGraph is the first Semantic Graph Database to be certified ...
(Date:2/8/2016)... England , February 8, 2016 ... Ltd ("Atlas Genetics" or the "Company"), the ultra-rapid Point-Of-Care (POC) ... to CE Mark its Chlamydia trachomatis (CT) test to be ... of the IVD Directive (98/79/EC), the CT test is now ... --> --> The launch of the io® ...
(Date:2/5/2016)... Feb. 5, 2016  In the pharmaceutical industry the ... host of launch activities including the identification and engagement ... activity is especially high in the oncology therapeutic area ... Practices and the Role of Medical Affairs in Oncology ... on oncology therapies find better ways to utilize medical ...
(Date:2/4/2016)... ... February 04, 2016 , ... Morf ... today announced an interactive FDA compliance training course, Writing Effective ... Professional Society) accredited interactive course on Morf Playbook—now conveniently available on smartphones and ...
Breaking Biology Technology:
(Date:1/25/2016)... , Jan. 25, 2016  Glencoe Software, the ... pharma and publication industries, will provide the data management ... Centre (NPSC). ... Phenotypic analysis measures ... whole organisms, allowing comparisons between states such as health ...
(Date:1/20/2016)... 2016   MedNet Solutions , an innovative SaaS-based ... clinical research, is pleased to announce the attainment of ... the result of the company,s laser focus on (and ... , it,s comprehensive, easy-to-use and highly affordable cloud-based technology ... Key MedNet growth achievements in 2015 include: ...
(Date:1/13/2016)... January 13, 2016 ... addition of the  "India Biometrics Authentication ... Forecast (2015-2020)"  report to their ... has announced the addition of the  ... - Estimation & Forecast (2015-2020)" ...
Breaking Biology News(10 mins):