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

SAN MARINO, Calif., July 9 /PRNewswire/ -- Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of all soft tissue sarcomas. This latest approval is the third clinical indication for which Rexin-G has been formally recognized by the FDA in the United States. This latest approval for Rexin-G validates the company's remarkable strategy of addressing a global unmet medical need by caring for one individual patient, one particular type of tumor, one otherwise intractable cancer at a time.

The clinical development of Rexin-G worldwide has been equally remarkable. Beginning with the most serious and life-threatening forms of pancreatic cancer, Rexin-G has demonstrated unprecedented single-agent efficacy in metastatic cancers of the colon, breast, skin, lung, and bone in a progressive program of expanded access that continues to achieve historic milestones. Eschewing any trappings of personal accomplishment, Epeius gives credit to the dedication and efforts of the many pioneering oncologists, the progressive medical institutions, and the conscientious regulatory agencies who have all served to guide Rexin-G, with its elegant tumor-targeting nanotechnologies, to the bedside. Most recently, Rexin-G has been approved in the Philippines for the treatment of all solid tumors that are refractory to standard chemotherapies.

In addition to developing the first and so far only tumor-targeted genetic medicine that has been validated in the clinic, Epeius Biotechnologies has assumed the daunting responsibilities of advancing these enabling platform technologies safely and effectively through an arduous array of regulatory hurdles and medical proofs-of-principle that are required for a radically new medicine. Initial Phase I safety studies established the general safety of Rexin-G, followed by Phase I/II efficacy studies where optimal clinical proto
'/>"/>

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

0

GOOD

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:5/17/2013)... -- New interactive learning forums will ... of the medical device industry at the 2013 ... from June 18-20 in Philadelphia ... ) , These all-new MedTech Innovate ... presentations and implementable solutions on the most cutting-edge ...
(Date:5/17/2013)... MIAMI , May 17, 2013  Insero Health, ... medical needs in epilepsy and related neurological disorders, is ... of its lead compound INS001 in patients with drug-resistant ... Drug and Device Trials (AED) Xll meeting by Dr. ... epileptologist and Chairman of Insero,s Scientific Advisory Board.  In ...
(Date:5/17/2013)... May 17, 2013 Rust removal is one ... non-metal home items could be damaged. To help rust contractors ... of its no-scrubbing rust remover it called Rusterizer. ... available with 10% discount. , My Cleaning Products explained that ... them or by staining them. The first one, it ...
(Date:5/16/2013)... ISPE announced today that ... the newly created position of Vice President of ... be responsible for stimulating ISPE’s revenue growth by ... Society’s Member-led and staff-driven business model, initiating integrated ... membership and product marketing. , “Barbara joins ISPE ...
Breaking Biology Technology:MedTech Innovate Seminars: New Interactive Learning Forums at 2013 MD&M East 2Insero Health Reports Positive Data on Phase I Trial of Novel Therapy for Drug-resistant Epilepsy 2Organic-Based Rust Remover Cuts Down Price by 10%, My Cleaning Products Details Mechanics How to Get the Discount 2ISPE Names Barbara A. Myers, CAE, as Vice President of Professional Development 2
... to Present at Rodman & Renshaw,10th Annual Healthcare Conference" ... Ltd nasdaq:ROSG over PR Newswire, we are advised by ... been added,below the first paragraph. Complete, corrected release follows:, ... a,leader in the development of microRNA-based diagnostics, announced today ...
... DENVER, Nov. 6 Corgenix Medical Corporation,(OTC Bulletin ... test kits, will host a conference call on ... discuss the Company,s financial and operating,performance for its ... the,status of the Company,s product development and marketing ...
... Atherotech to add new apoA1 measurement and apoB:apoA1 ratio to its, ... ... heart disease, BIRMINGHAM, Ala., Nov. ... exhibiting its VAP(R),Cholesterol Test in booth No. 2918 at the American ...
Cached Biology Technology:/C O R R E C T I O N -- Rosetta Genomics Ltd/ 2/C O R R E C T I O N -- Rosetta Genomics Ltd/ 3/C O R R E C T I O N -- Rosetta Genomics Ltd/ 4/C O R R E C T I O N -- Rosetta Genomics Ltd/ 5/C O R R E C T I O N -- Rosetta Genomics Ltd/ 6Atherotech to Exhibit VAP(R) Cholesterol Test at American Heart Association Scientific Sessions 2008 2
(Date:5/16/2013)... in neurodegenerative disease also plays a critical role in ... In a study of the common fruit fly, the ... responsible for sleeping and waking on a 24-hour rhythm. ... sleep-wake cycle is disturbed, making waking up on a ... discovery is particularly interesting because mutations in the human ...
(Date:5/16/2013)... 2013 Integrated Biometrics patented LES (Light ... thin film transistor camera introduces Sherlock, a fingerprint ... in the smallest and lightest form factor available ... Mobile ID FAP 45, Certified scanner is highly ... and weight when compared to optical scanners. ...
(Date:5/16/2013)... world are meeting next week in Toronto. The ... latest in research findings about the brain, the ... disorders that affect them., "Canada is a leader ... the best of neuroscience research done here and ... the Canadian Association for Neuroscience. He also reminds ...
Breaking Biology News(10 mins):Gene involved in neurodegeneration keeps clock running 27th Annual Canadian Neuroscience Meeting, Toronto, May 20-24, 2013 2
... of human embryonic stem cell research receives a tremendous ... the potential of adult stem cells for possible therapies. ... cell research isn't fraught with the controversies that surround ... to isolate and then to multiply in a lab ...
... at the University of Washington and their colleagues at other ... lifespan of mice while reducing the impact of the aging ... journal Science on May 5, lends more credence to the ... reactive chemicals, called "free radicals," can be damaging to the ...
... customized nanoparticles that they developed, University at Buffalo scientists ... brains of living mice with an efficiency that is ... no observable toxic effect, according to a paper published ... Sciences. , The paper describes how the UB scientists ...
Cached Biology News:Researchers discover mechanism for multiplying adult stem cells 2Researchers extend mouse lifespan by protecting against free radicals 2Researchers extend mouse lifespan by protecting against free radicals 3Using nanoparticles, in vivo gene therapy activates brain stem cells 2Using nanoparticles, in vivo gene therapy activates brain stem cells 3
... Basically, most ``special`` dye stains are ... few other non-routine) stains are $9.00. ... a paraffin block, staining, coverslipping and ... (for senile plaques) ,Bodian`s Stain ,Copper ...
... Yeast Whole Genome ChIP-on-chip Microarray is ... yeast (S. cerevisiae) DNA binding proteins ... Agilent DNA microarrays. This set delivers ... with greater true binding events and ...
... S. pombe Whole Genome ChIP-on-chip Microarray ... of yeast (S. pombe) DNA binding ... with Agilent DNA microarrays. This set ... data with greater true binding events ...
... This kit is designed for easy transformation ... protocol allows for successful transformation simply by ... reagents with cultured yeast cells. No complicated ... are required. The kit is particularly well ...
Biology Products: