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:6/27/2016)...  Liquid Biotech USA , ... Sponsored Research Agreement with The University of Pennsylvania ... cancer patients.  The funding will be used to ... clinical outcomes in cancer patients undergoing a variety ... employed to support the design of a therapeutic, ...
(Date:6/24/2016)... ... June 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers ... the 6000i models are higher end machines that use the more unconventional z-dimension of ... beam from the bottom of the cuvette holder. , FireflySci has developed several ...
(Date:6/23/2016)... 23, 2016   Boston Biomedical , an ... designed to target cancer stemness pathways, announced that ... Orphan Drug Designation from the U.S. Food and ... cancer, including gastroesophageal junction (GEJ) cancer. Napabucasin is ... inhibit cancer stemness pathways by targeting STAT3, and ...
(Date:6/23/2016)... ... 2016 , ... Charm Sciences, Inc. is pleased to announce ... Research Institute approval 061601. , “This is another AOAC-RI approval of the Peel ... President of Regulatory and Industrial Affairs. “The Peel Plate methods perform comparably to ...
Breaking Biology Technology:
(Date:4/13/2016)... 2016  IMPOWER physicians supporting Medicaid patients in ... clinical standard in telehealth thanks to a new partnership ... platform, IMPOWER patients can routinely track key health measurements, ... index, and, when they opt in, share them with ... a local retail location at no cost. By leveraging ...
(Date:3/29/2016)... 2016 LegacyXChange, Inc. (OTC: ... SelectaDNA/CSI Protect are pleased to announce our successful effort ... variety of writing instruments, ensuring athletes signatures against counterfeiting ... from athletes on LegacyXChange will be assured of ongoing ... Bill Bollander , CEO states, "By ...
(Date:3/22/2016)... PROVO and SANDY, Utah ... Ontario (NSO), which operates the highest sample volume laboratory ... and Tute Genomics and UNIConnect, leaders in clinical sequencing ... announced the launch of a project to establish the ... panel. NSO has been contracted by ...
Breaking Biology News(10 mins):