Navigation Links
ADVENTRX Announces 9-Month Stability Data Results for ANX-530

SAN DIEGO, June 30 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company's intended commercial manufacturing site.  The 9-month stability data are on track to support the submission of a New Drug Application (NDA) for Exelbine.  

"These results are consistent with our expectations and what we anticipate from the 12-month data," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "Once the 12-month data is analyzed, we will prepare and submit the Exelbine NDA, which we expect will take place in the fourth quarter of this year."

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are designed to improve the performance of existing cancer treatments by addressing limitations associated principally with their safety and use.  More information can be found on the Company's web site at  

Forward Looking Statements

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements.  These risks and uncertainties include, but are not limited to: the risk that future stability testing results are not consistent with prior results or are out-of-specification or otherwise do not support comparability between ADVENTRX's prior and intended commercial manufacturing sites or a commercially-viable expiration dating period; the risk that the FDA does not accept a submitted Exelbine NDA for review, including as a result of identifying clinical or nonclinical reasons for a refusal-to-file or identifying CMC reasons that were not identified in the refusal-to-file of the previously submitted Exelbine NDA; ADVENTRX's dependence on the success of Exelbine, and uncertainty as to whether Exelbine will receive regulatory approval or be commercialized successfully; the risk that the bioequivalence data and other information included in the Exelbine NDA may not adequately support bioequivalence with Navelbine®; the potential that changes made in transferring the manufacturing process for Exelbine may result in a lack of comparability between the commercial product and the material used in the bioequivalence trial, and that the FDA may require ADVENTRX to perform additional nonclinical, bioequivalence or clinical studies; the potential for the FDA to impose other requirements to be completed before or after approval of the Exelbine NDA; the risk that ADVENTRX will pursue development activities at levels or on timelines, or will incur unexpected expenses, that shortens the period through which its operating funds will sustain it; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at  

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made.  ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.

SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ADVENTRX Added to Russell Microcap Index
2. ADVENTRX Pharmaceuticals to Present at the Rodman & Renshaw Annual Global Investment Conference on May 17
3. ADVENTRX Pharmaceuticals Announces Closing of Financing
4. ADVENTRX Reverse Split Effective; Trading on Adjusted Basis Begins Today
5. ADVENTRX Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2009 Financial Results
6. ADVENTRX Receives Brand Name Acceptance for ANX-530
7. ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
8. ADVENTRX Announces Management Promotions
9. ADVENTRX Appoints Icahn Representative to Board of Directors
10. ADVENTRX Pharmaceuticals to Present at the 12th Annual BIO CEO & Investor Conference on February 9
11. ADVENTRX Pharmaceuticals to Present at the Lippert/Heilshorn Life Sciences Virtual Conference
Post Your Comments:
(Date:11/29/2015)... , Nov. 29, 2015  Strengthening its leadership ... PHG, AEX: PHIA) today announced IntelliSpace Portal 8.0 ... analytics and visualization platform that helps radiologists detect, diagnose ... 2015 Radiological Society of North America Annual Meeting ... IntelliSpace Portal 8.0 helps address the changing demands in ...
(Date:11/29/2015)... , Nov. 29, 2015  At this year,s ... to experience the most complete mobile C-arm portfolio with ... is Ziehm Vision RFD 3D, the world,s only 3D ... edge length per scan volume. In addition, Ziehm Imaging ... motorized mobile C-arm in four axes which is ideally ...
(Date:11/29/2015)... 29, 2015 CIVCO Medical Solutions will ... the Radiological Society of North America ... November 29 – December 4, 2015. ... offer customers unrivaled versatility, enhanced user experience and ... --> ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... International ... UPMC and KingMed Diagnostics researchers. Their review of more ... consultation with UPMC pathologists resulted in significantly altered treatment plans for more than ...
(Date:11/30/2015)... ... November 30, 2015 , ... ”Dying Words: The AIDS Reporting ... on December 1, 2015, to coincide with World AIDS Day. The multi-media project will ... covered the AIDS epidemic as he was dying of the disease. , A collaborative ...
(Date:11/30/2015)... ... November 30, 2015 , ... The Foundation for Breast and ... prevention—is joining forces with the award-winning creator and writer of Downton Abbey Julian ... 2015 at the Union League of Philadelphia. , The benefit, titled “An ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... Ingredients (ASI) as their exclusive channel partner for the Nutraceutical Specialties products into ... in the US, effective immediately. , “We are pleased to announce our ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... Analytics for the last 15 years, announced today that Michigan-based Family Health Center ... of care for over 45 years, FHC was awarded the largest Affordable Care ...
Breaking Medicine News(10 mins):