Navigation Links
ADVENTRX Announces 9-Month Stability Data Results for ANX-530
Date:6/30/2010

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 www.adventrx.com.  

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 www.sec.gov.  

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:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... Inc ., a digital health company focused on modernizing and ... $25 million in Series B funding led by Qiming US ... Seattle that is part of a broader family ... included participation from SR One , who led ZappRx,s ... Google Ventures). As part of the financing, Mark McDade ...
(Date:4/20/2017)... Research and Markets has announced the ... Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies ... ... was valued at US$ 7,167.6 Mn in 2015, and is ... a CAGR of 5.6% from 2016 to 2024. ...
(Date:4/20/2017)... 20, 2017 NeuroVive Pharmaceutical AB (Nasdaq ... positive preclinical results demonstrating anti-fibrotic effects with ... steatohepatitis (NASH), in an additional well-validated experimental ... has previously shown similar anti-fibrotic effects in ... scientists present novel data demonstrating anti-fibrotic effects ...
Breaking Medicine Technology:
(Date:4/24/2017)... ... April 24, 2017 , ... ... opioid overdose deaths now claim the lives of 62 Americans each day.(1) Yet ... against drug manufacturers, distributors, pharmacies and prescribers by more than half.(2) Novus ...
(Date:4/24/2017)... ANGELES, CA (PRWEB) , ... April 24, 2017 , ... ... picture is worth a thousand words. The good news for single women is that ... for Attraction," which is available on April 25th. Joan's insight, personal experiences and sparkling ...
(Date:4/24/2017)... ... ... “Reflections of God’s Work”: an enlightening collection of life lessons leading each ... published author, Jerri Broglin, a survivor of great loss who gained insight on how ... for those searching for answers, as we are finding the answers that are so ...
(Date:4/24/2017)... NC and Seattle, WA (PRWEB) , ... April ... ... utilized by 75+ leading lifestyle brands, work wear distributors and International relief organizations ... they can carry. The company also offers lifestyle and work wear collections via ...
(Date:4/22/2017)... ... April 22, 2017 , ... Ecommerce sales have grown every year since ... $394.9 billion. The consequences of rapid innovation and growth are often neglected in ... it is every business and individual’s job to give something back to the planet ...
Breaking Medicine News(10 mins):