Navigation Links
Epeius Biotechnologies' REXIN-G, a Tumor-Targeted Genetic Medicine for Metastatic Cancer, Gains Phase 3 Product Designation From the U.S. FDA
Date:2/28/2011

SAN MARINO, Calif., Feb. 28, 2011 /PRNewswire/ -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today that the U.S. FDA has granted Phase 3 status for the Company's lead anti-cancer agent, Rexin-G, the first, and so far only, targeted gene delivery system developed to seek out and destroy metastatic cancer. According to Dr. Maria Gordon, Chief Medical Officer of Epeius, "What this means, in terms of clinical development, is that the Rexin-G product, with its advanced GMP manufacturing, bio-processing, and final formulation, meets rigorous FDA standards for obtaining a marketing license in the future; and that Epeius Biotech can now proceed with its strategic, diversified Phase 3 drug development program for pancreatic cancer, osteosarcoma and soft tissue sarcoma."

In addition to these high-priority programs, Rexin-G has demonstrated significant anti-tumor activity in chemotherapy-resistant breast cancer, hormone-refractory prostate cancer, ovarian cancer, squamous cell carcinoma, and certain hematologic malignancies, such as large B-cell lymphoma.

Rexin-G® was granted accelerated approval for the treatment of all chemotherapy-resistant solid malignancies in the Republic of the Philippines in 2007. In the U.S.A., Rexin-G gained Orphan Drug Designation and market protections from the FDA for pancreatic cancer in 2003, followed by Orphan Drug Status for both osteosarcoma and soft tissue sarcoma in 2008.  More recently, Epeius Biotechnologies completed a series of Phase 1 and Phase 2 clinical trials in the U.S., establishing the thresholds for bioactivity and dose-dependent efficacy for Rexin-G against a number of otherwise intractable cancers, as well as the product's overall safety over extended survival times and a notable lack of either safety issues or dose-limiting toxicities.

With these development-stage accomplishments at hand, Epeius is gearing up to open a series of pivotal studies for both pancreatic cancer and sarcomas in the U.S., while continuing to advance the clinical utility and market development of Rexin-G worldwide. With the completion of the enabling platform development and the clinical validation of its foremost oncology product, Epeius Biotechnologies continues to lead the field of genetic medicine with the development of its product pipeline, which includes Reximmune-C, a tumor-targeted gene delivery system for 'personalized' cancer vaccinations, administered to stimulate a long-lasting anti-tumor immunity.

For further information about Epeius Biotechnologies, its lead products, and its clinical trials, please contact Erlinda M. Gordon, M.D., at egordon@epeiusbiotech.com.

  • Logo 72dpi: Send2PressNewswire.com/image/11-0228-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 Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Epeius Biotechnologies Reports Major Clinical Advances: Noteworthy Clinical Case Studies in Cancer Gene Therapy
2. Epeius Biotechnologies Corporation Expands its Rexin-G Production Facilities in Southern California
3. Epeius Biotechnologies to Partner at BIO Investor Forum
4. Beginners Luck, or Creative Artists of the First Rank? Epeius Biotechnologies Launches Rexin-G eBook Tutorial
5. Epeius Biotech Awarded Patents in Europe for Targeted Genetic Anti-Cancer Medicine: Company Expands Impressive Intellectual Property Estate
6. Targeting Metastatic Cancer From the Inside: Epeius Biotech Reveals a New Generation of Tools for Medical Gene Delivery
7. Epeius Biotechnologies Lead Product, Rexin-G for Metastatic Cancer, Aptly Highlighted by National Cancer Institute Journal
8. Reportlinker Adds Nanobiotechnologies- applications, markets and companies
9. TriLink BioTechnologies Launches CleanAmp™ 7-deaza-dGTP for GC-rich Target Amplification
10. Maven Biotechnologies Receives $1.96 Million From the National Institutes of Health (NIH) to Develop Their LFIRE™ Label-Free Detection Technology for Proteomics
11. Reportlinker Adds Nanobiotechnologies- Applications, Markets and Companies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... International research firm Parks Associates announced today that Tom ... 2017 Annual Meeting , October 11 in Scottsdale, Arizona ... and how smart safety and security products impact the competitive landscape. ... Parks Associates: Smart Home Devices: Main Purchase Driver ... "The residential security market has experienced continued growth, and ...
(Date:10/10/2017)... ... October 10, 2017 , ... The Pittcon Program Committee ... honoring scientists who have made outstanding contributions to analytical chemistry and applied ... the world’s leading conference and exposition for laboratory science, which will be held ...
(Date:10/9/2017)... ... October 09, 2017 , ... At its national board meeting in ... professor in Harvard University’s Departments of Physics and Astronomy, has been selected for membership ... the winning team for the 2015 Breakthrough Prize in Fundamental physics for the discovery ...
(Date:10/7/2017)... ... October 06, 2017 , ... ... applications consulting for microscopy and surface analysis, Nanoscience Instruments is now expanding ... offers a broad range of contract analysis services for advanced applications. Services ...
Breaking Biology Technology:
(Date:8/23/2017)... N.Y. , Aug. 23, 2017  The general public,s help is ... human microbiome—the bacteria that live in and on the human body –and ... The ... in the human microbiome, starting with the gut. The project's goal is ... disease. Photo credit: IBM ...
(Date:6/14/2017)... IBM ) is introducing several innovative partner startups at ... between startups and global businesses, taking place in ... startups will showcase the solutions they have built with IBM ... France is one of the most ... increase in the number of startups created between 2012 and ...
(Date:4/24/2017)... WASHINGTON , April 24, 2017 ... counsel and partner with  Identity Strategy Partners, LLP ... "With or without President Trump,s March 6, ... Foreign Terrorist Entry , refugee vetting can be instilled ... refugee resettlement. (Right now, all refugee applications are ...
Breaking Biology News(10 mins):