Navigation Links
Epeius Biotechnologies' Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer

SAN MARINO, Calif., June 17 /PRNewswire/ -- Epeius Biotechnologies ( announced today that its lead product, Rexin-G, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use as a second-line treatment for advanced or metastatic pancreatic cancer. The FDA Fast Track program, like Priority Review and Accelerated Approval, was implemented to facilitate the development and expedite the review of potentially important new drugs. The Fast Track Product designation, in particular, is granted following a critical evaluation of the "seriousness" or life-threatening nature of the unmet medical need, namely pancreatic cancer, and the potential of Rexin-G and its progressive clinical development to address this unmet need.

"This is an excellent affirmation of all that we have worked for," says Dr. Erlinda Maria Gordon, Medical Director of Epeius Biotechnologies, "and an important validation of our medical mission." Indeed, Rexin-G is the first in an entirely new class of targeted anti-cancer agents, with a sophistication that goes well beyond a simplistic antibody. Rexin-G is the flagship of tumor-targeted genetic medicine: "smart," "stealth," "selective" and "potent" nano-medicine that not only seeks out and accumulates in cancerous lesions that have spread throughout the body, but delivers a tumor-killing designer gene where it is needed most, selectively destroying tumor cells and their attendant blood supply, while sparing normal cells and healthy tissues. As presented at the 2009 ASCO G.I. Symposium, "Rexin-G Shrinks Metastatic Tumors and Triples Survival Time in Chemotherapy-Resistant Pancreatic Cancer," documenting survival benefits, without toxicity, as monotherapy, when all else fails.

The FDA's timely decision to grant Rexin-G Fast Track Product Designation is not only validating in terms of the potential of this Investigational New Drug to meet an unmet medical need, but it reflects on the design and integrity of the clinical development program of Epeius Biotechnologies. "It took years of sustained effort, but our decision to firmly establish the overall safety of repeated infusions of Rexin-G in early-stage clinical trials, before we moved on to progressively higher doses, has served us well," said Dr. Gordon. "For it was in determining the actual needs of our patients, in concordance with ongoing FDA guidance, that eventually achieved the control of tumor growth and metastasis," she added.

Remarkably, the adaptive designs of the strategic dose-escalation studies not only served to confirm the overall safety of Rexin-G and the lack of either systemic or dose-limiting toxicity, but it served to establish the critical thresholds of bioactivity and the dose-response relationships in several intractable cancers, which confirms and reveals the physiological mechanisms-of-action. These quantitative aspects of applied pharmacology are of paramount importance in establishing the clinical utility of a major new class of biological agents. Moreover, the progressive and adaptive trial designs helped to create and refine the clinical protocols for future medical praxis.

About Epeius Biotechnologies

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its high-performance gene delivery systems that are embodied in Rexin-G and Reximmune-C, a tumor-targeted cancer vaccine. To learn more about ongoing clinical trials, please contact Dr. Erlinda M. Gordon at

*(LOGO 72dpi: )

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

SOURCE Epeius Biotechnologies
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Therapure Biopharma Inc. and LFB Biotechnologies Announce Development Services Contract for New Therapeutic Protein
2. Millennium Biotechnologies Reports Strong Third Quarter Revenue and Financial Results
3. Ezra Van Gelder Joins Microchip Biotechnologies as Executive Vice President R&D
4. Veteran of the Beverage Industry, Ken Sadowsky, Joins Millennium Biotechnologies Board of Directors
5. MDS Analytical Technologies Acquires Blueshift Biotechnologies
6. Millennium Biotechnologies Inc. Signs Five Year $20,000,000 Purchase Agreement with Provider Services Inc. of Cleveland, Ohio
7. VaxGen and Raven biotechnologies Announce Signing of Definitive Merger Agreement
8. Rexin-G Controls Tumor Growth and Improves Survival in Chemotherapy-Resistant Sarcoma and Osteosarcoma: Phase I/II and Phase II Studies, ASCO 2009
9. FDA Approves the Opening of a Phase II Registration Protocol Using REXIN-G(R) for Osteosarcoma in California U.S.A.
10. STAAR Surgical Receives Japanese Clearance for the KS-Ni Preloaded IOL Injector System
11. Herzing University, Minneapolis Receives Board of Nursing Approval
Post Your Comments:
(Date:11/28/2015)... Viejo, CA (PRWEB) , ... November 28, 2015 , ... ... new fully customizable media panels to choose from, the possibilities are endless. Users have ... and more. With the ProPanel: Pulse masking effects, users are sure to get heads ...
(Date:11/27/2015)... ... ... According to an article published November 15th by ABC News, ... in light of the recent terrorist attacks in Paris, other cities are taking extra ... from reaching U.S. soil. Especially around special events that may be high-profile in nature, ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... toilets were," said an inventor from Hillside, N.J. "Many people catch diseases simply ... so that individuals will always be protected from germs." , He developed the ...
(Date:11/27/2015)... ... November 27, 2015 , ... MPWH, the No.1 Herpes-only dating community in the world, revealed that ... ). More than 3.7 billion people under the age of 50 – or 67% ... WHO's first global estimates of HSV-1 infection . , "The data shocks us highly!" ...
(Date:11/27/2015)... ... November 27, 2015 , ... The moment you ... for not only fulfilling the needs of advisers and clients but going above ... and providing top-tier customer service. However, there's always room for improvement, which is ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... --> adds "Global ... and "Investigation Report on China Repaglinide ... 2021 forecasts data and information to ... . --> ...
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ... the "2016 Future Horizons and Growth Strategies ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> --> This ... the Italian therapeutic drug monitoring market, including emerging ...
(Date:11/26/2015)... , November 26, 2015 ... the addition of the  "2016 Future ... European Cell Surface Marker Testing Market: ...  report to their offering.  --> ... addition of the  "2016 Future Horizons ...
Breaking Medicine Technology: