Navigation Links
FDA Grants Epeius Biotechnologies' Rexin-G a Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas
Date:7/9/2008

cols were established for each particular type of tumor. The importance of these progressive dose-escalation studies -- which clearly establish safety before escalating to more potent tumoricidal dose levels -- is of primary concern in the development of a new genetic medicine like Rexin-G. Moreover, the establishment of a functional dose-response relationship is of fundamental significance, not only in terms of basic pharmacology, but in establishing the physiological mechanisms-of-action that are of major importance in determining the predictability of a new anti-cancer agent and ultimately in gaining full regulatory approval for Rexin-G in the United States.

Based on the scientific and medicinal merits of Rexin-G, as well as the rarity, seriousness, and lack of effective therapies for metastatic cancers, the granting of a third Orphan Drug Designation by the FDA at this time is both encouraging and confirmatory. Orphan Drug Designation provides important economic incentives and powerful market protections that encourage the development of innovative products in the cancer field. U.S. Orphan Drug Designation provides seven years of market exclusivity for Rexin-G, a reduction in fees and taxes, and additional regulatory support for ongoing R&D initiatives.

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 proprietary targeted delivery systems. To learn more about our pipeline of biotechnologies and products that are currently available for licensing and clinical development, please visit our website, http://www.epeiusbiotech.com.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

This release was issued on behalf of the
'/>"/>

SOURCE Epeius Biotechnologies
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. US FDA Grants Pediatric Exclusivity for UCBs Keppra(R)
2. Xceed Molecular Grants Gen-Probe License to Xceeds Flow-Thru Chip(R) Technology for Multiplex Molecular Diagnostics
3. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
4. Intellect Neurosciences, Inc. Grants License for Certain Patents and Patent Applications to Wyeth and Elan Pharma International Ltd.
5. Lentigen Corporation Receives Four Research Grants From the National Institutes of Health
6. Susan G. Komen for the Cure(R) Announces Largest Grants Slate Ever: $100 Million to Speed Delivery of Breast Cancer Discoveries, Cures
7. European Union, State of Brandenburg, Award Grants to Alcat Europe, GmbH
8. FDA Grants Market Clearance to Aerocrine Inc.s NIOX MINO(R): a New Hand-Held Device to Measure Airway Inflammation in Asthma
9. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
10. United States Patent Office Grants CryoCors Request for Patent Interference
11. Christopher and Dana Reeve Foundation Awards Nearly $2 Million in Individual Research Grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... 2014  Alternative Energy & Environmental Solutions, Inc., ... a letter of intent to acquire BioTechPharma Corporation, ... a nanotechnology-based development platform used to create drug ... on-site collection and testing to identify infectious disease, ... an immediate, non-invasive and cost-effective manner. ...
(Date:12/22/2014)... VIEJO, Calif. , Dec. 22, 2014  ( ... that CoPatient, an online medical bill review and advocacy ... offering in the FREE WellCard Savings discount health services ... medical bill that was more than they expected to ... members reduce health care costs, WellCard Savings is pleased ...
(Date:12/22/2014)... December 22, 2014 ITRA Global, one ... occupiers of commercial real estate, has further expanded its ... in Perth and Brisbane, Western Australia, reports Mylinda Vick, ... , ITRA Global / ACORPP (Australian Corporate Property ... consultancy company providing property services to a wide range ...
(Date:12/19/2014)... PA (PRWEB) December 19, 2014 ... leading developer and manufacturer of needle-free injection technology, ... agreement with Immunomic Therapeutics, Inc. (“ITI”) for ITI ... device with its LAMP™ vaccine platform. , ... an exclusive Worldwide license to the Biojector®-2000 that ...
Breaking Biology Technology:ALNE Announces Intention To Acquire BioTechPharma 2WellCard Savings Announces CoPatient Medical Bill Review Service for Members 2ITRA Global Continues International Expansion in Perth and Brisbane, Australia 2Bioject and Immunomic Therapeutics Enter into an Agreement for License of Needle-Free Technology for LAMP-vax Vaccines 2Bioject and Immunomic Therapeutics Enter into an Agreement for License of Needle-Free Technology for LAMP-vax Vaccines 3
... to see is based on molecules in the eye ... to visible light. Now, a new technique for ... molecules to be switched between two different configurations in ... Because the configuration changes are reversible and can be ...
... Bion Environmental,Technologies, Inc. (OTC Bulletin Board: BNET) today ... environmental,treatment technology compared to anaerobic digesters., Anaerobic ... produce energy,from livestock waste since the late 1800s. ... is still based on a biological process that,produces ...
... Premier healthcare,alliance Purchasing Partners division recently announced ... one of 15 winners,chosen for the Pinnacle ... suppliers,representing the top two percent of healthcare ... exceeds the expectations of,Premier and its members ...
Cached Biology Technology:Tethered molecules act as light-driven reversible nanoswitches 2Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters 2Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters 3Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters 4Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters 5Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters 6Bion Outlines Differences between its Patented Comprehensive Livestock Environmental Treatment Technology and Anaerobic Digesters 7Premier Healthcare Alliance Honors Siemens Healthcare Diagnostics for Excellence in Supplier Performance 2Premier Healthcare Alliance Honors Siemens Healthcare Diagnostics for Excellence in Supplier Performance 3
(Date:12/17/2014)...  Automation is fundamentally transforming the travel experience ... international borders. Over the past decade, ePassports, biometric ... travelers to self process through border control via ... an increasing number of airports, seaports, and land ... to Maxine Most , Principal at Acuity ...
(Date:12/11/2014)... , Dec. 10, 2014  Data Sciences ... monitoring, has released a new series of digital ... preclinical toxicology researchers. M series, part of the ... collect the best possible physiologic data when incorporating ... Adding functional endpoints to toxicology studies has evolved ...
(Date:12/10/2014)... Dec. 08, 2014 Research and Markets ... of the "Biometrics Market in Japan 2014-2018" ... http://photos.prnewswire.com/prnh/20130307/600769 The integration ... as rural banking and upgradation of the driver,s ... in the market. Besides the aforementioned projects, biometrics ...
Breaking Biology News(10 mins):Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2New telemetry implants expected to change how large animal toxicology studies are conducted 2Biometrics Market in Japan 2014-2018: Key Vendors are DDS, Fujitsu, Hitachi and NEC 2
... in Spanish . , Pioneering studies ... Robert A. Waterland are helping explain how the foods ... the time of conceptionor what,s known as periconceptional nutritionmay ... her children,s health. In an early study, Waterland ...
... lack of very long chain fatty acids in photoreceptor cells ... an incurable eye disease. But researchers at the University of ... new study that lack of these fatty acids does not ... robs sight from children with the disease must start anew. ...
... mean failure of both summer and winter rains, according to ... The finding contradicts the commonly held belief that a ... monsoon season, and vice versa. The new research ... 1539 to 2008, generally both winter and summer rains were ...
Cached Biology News:Epigenetics mechanism may help explain effects of mom's nutrition on her children's health 2Long-suspected cause of blindness from eye disease disproved 2Monsoon failure key to long droughts in Southwest 2Monsoon failure key to long droughts in Southwest 3
Ideal for chemical processing that requires downward flow of exhaust fumes. Powderful 1200 CFM blower draws fumes into sub-surface bonded charcoal filter for safe removal of organic vapors (final HEP...
... preparative LC/MS, using mass numbers as a ... ideal for performing investigation and research of ... both analytical and preparative operation. Switching between ... the software. This support provides a quick ...
... Intracellular Localization Kit provides a straight forward ... of your design, in an efficient yet ... Subcellular localization and functional inhibition of target ... of the labeled siRNA into mammalian cells. ...
Selective media for Salmonella...
Biology Products: