Navigation Links
ADVENTRX Announces ANX-514 Clinical Development Plan Affirmed by the FDA
Date:9/10/2007

SAN DIEGO, Sept. 10 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) regarding its proposed 505(b)(2) New Drug Application (NDA) regulatory path for ANX-514 (docetaxel emulsion). The FDA has indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of ANX-514 and docetaxel is sufficient to support filing an NDA. Docetaxel is an anti-cancer agent that is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers, and is marketed under the brand name Taxotere(R). Annual sales of Taxotere in 2006 were approximately $2.2 billion.

"This guidance from the FDA is significant as conducting a single marketing-enabling trial provides us a clear and direct clinical path and substantially shortens the timelines for clinical development and submitting an NDA for ANX-514," said Evan M. Levine, chief executive officer of ADVENTRX. "Pending appropriate clearances, we look forward to starting the proposed bioequivalence trial later this year."

The Company currently plans to submit an investigational new drug (IND) application in the fourth quarter of 2007. The proposed clinical trial will compare the blood levels of docetaxel following a single dose of ANX-514 or Taxotere in patients with advanced cancers. In addition, the Company plans to analyze the safety of ANX-514.

ANX-514 Preclinical Results

Preclinical results have demonstrated equivalent pharmacoki
'/>"/>

SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related biology technology :

1. Speaker announces business members of IT Task Force
2. Doyle announces technology tax credits for Berbee
3. Doyle announces new energy, global warming policies
4. Doyle announces $80M renewable energy strategy
5. GE announces first installation of Discovery VCT
6. UWM announces winners of RGI awards
7. Third Wave announces two senior management appointments
8. Mirus announces new method for making antibodies
9. Merge announces sofware updates, upcoming acquisition
10. Small Tree announces ethernet solution for Apple Xserv G5
11. TEKLYNX International announces new RFID software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/17/2013)... available in German . ... the naked eye, you can see which branch a bird ... of branches through the telephoto lens for high-magnification images requires ... are looking to study proteins, the active biomolecules of cells. ... for Molecular Systems Biology, and her colleagues have now come ...
(Date:5/17/2013)... May 17, 2013 •    First of its ... for sustainability ,     New facility will help solve ... , Syngenta unveiled its new crop research ... company’s RTP Innovation Center. The first of its kind, ... simulate any agricultural climate and precisely measure plant inputs ...
(Date:5/17/2013)... May 17, 2013  Yongye International, Inc. (NASDAQ: ... developer, manufacturer, and distributor of crop nutrient products in ... today announced that, on May 16, 2013, the special ... (the "Board of Directors") was provided a letter (the ... Kong ) Limited ("Abax") to Full Alliance International ...
(Date:5/17/2013)... Men’s skin is biologically different than women’s ... and has been known to react more aggressively when hormones ... far from puberty, other acne causing factors like P.acnes bacteria ... threatening skin with unsightly acne scars. Adult acne treatment, Probiotic ... on how to reduce and prevent acne scarring. , ...
Breaking Biology Technology:Proteome atlas for the tuberculosis pathogen 2Proteome atlas for the tuberculosis pathogen 3Syngenta Opens Unique $72 Million Advanced Crop Lab 2Syngenta Opens Unique $72 Million Advanced Crop Lab 3Yongye International Provides Update on Status of Proposed Go Private Offer 2Yongye International Provides Update on Status of Proposed Go Private Offer 3Yongye International Provides Update on Status of Proposed Go Private Offer 4Adult Acne Treatment, Probiotic Action Shares New Insight on Why Men’s Skin Scars from Acne and How to Prevent It 2
... Oct. 14 Althea Technologies, Inc., a leading,provider ... manufacturing, announced today that it has been honored ... Diego Technology Fast 50,and the San Diego Business ... consecutive year. The Deloitte Technology Fast 50 is ...
... Subjects with Decreased Enzyme Activity Appear Years Younger, ... Nu Skin,Enterprises Inc. (NYSE: NUS ) presented ... International Federation of Societies of Cosmetic Chemists,Congress (IFSCC) ... a,newly identified age-related enzyme, arNOX, and a person,s ...
... ... with cells from pigs, MINNEAPOLIS, Oct. 13 ... link for the diabetes cure. By,raising premier source pigs in a ... widespread availability,of islet tissue (insulin-producing cells of the pancreas), is taking ...
Cached Biology Technology:Althea Technologies Receives Fast Growth Honors: Deloitte Technology Fast 50 and San Diego Business Journal Fast 100 Awards for the Fifth Consecutive Year 2Nu Skin Scientists Correlate the Appearance of Aging With arNOX Free Radical Generator 2Nu Skin Scientists Correlate the Appearance of Aging With arNOX Free Radical Generator 3Spring Point Project Welcomes Second Generation 'Medical-Grade' Piglets 2Spring Point Project Welcomes Second Generation 'Medical-Grade' Piglets 3Spring Point Project Welcomes Second Generation 'Medical-Grade' Piglets 4
(Date:5/18/2013)... Orlando, FL (May 18, 2013) Research presented ... for managing digestive health through diet and lifestyle. ... often plagued by reduced muscle strength, fatigue and ... even when patients are in remission. A randomized, ... time that vitamin D supplementation corresponded to significant ...
(Date:5/17/2013)... provide the white noise of the South, but the night ... Southern air hangs heavy from the humidity and the sounds ... 140 species of frogs, toads and salamanders, is the center ... and swamps are the auditorium for their symphonic choruses, the ... Initiative, or ARMI, have front-row seats. , Amphibians, ...
(Date:5/17/2013)... of proteins in the brain responsible for protecting nerve ... could increase cell survival. , The discovery, made by ... in the EMBO journal with additional comment ... for stroke and other brain diseases. , The research ... a protein, known as SUMO, responsible for controlling the ...
Breaking Biology News(10 mins):Research examines new methods for managing digestive health 2Research examines new methods for managing digestive health 3Front-row seats to climate change 2Front-row seats to climate change 3Front-row seats to climate change 4SUMO wrestling cells reveal new protective mechanism target for stroke 2
... the University of Chicago have uncovered an important mechanism ... in the part of the brain that interprets visual ... first experimental evidence for a decades-old model of how ... can consistently relay spatial information. , In the January ...
... is abundant in the brain's hypothalamus, serves as the ... neural circuitry that controls feeding behavior in mice. , ... regulate appetite and eating behavior could eventually provide new ... The research, reported on-line April 9 in the journal ...
... materials used to display information on cell phones, monitors ... report in real time on the differentiation of embryonic ... which embryonic stem cells gradually turn into function-specific types ... heart or brain cells. , The main challenge facing ...
Cached Biology News:Chemical signaling helps regulate sensory map formation in the brain 2Chemical signaling helps regulate sensory map formation in the brain 3Hap1 protein links circulating insulin to brain circuits that regulate feeding behavior in mice 2Liquid crystals show promise in controlling embryonic stem cells 2
... J. Davison and Richard ... Contents include: information on ... paramyxoviruses, influenza and immunodeficiency ... analysis of viral NA ...
...
...
...
Biology Products: