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 pharmacokinetics between ANX-514 (docetaxel emulsion) and the FDA-approved version of docetaxel, marketed under the brand name Taxotere. ANX-514 administered intravenously did not cause hypersensitivity reactions, as opposed to acute hypersensitivity reactions that were observed following intravenous treatment with Taxotere. Antitumor activity of the two products in animal models was similar.

About ANX-514 (docetaxel emulsion)

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, which is marketed under the brand name Taxotere. ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and/or incidence of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.

About Section 505(b)(2)

Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows the FDA to approve a follow-on drug on the basis of data in the scientific literature or conclusions regarding safety or effectiveness made by the FDA in the approval of other drugs. This regulatory pathway potentially makes it easier for drug manufacturers to obtain rapid approval of new forms of drugs based on the FDA's approval of the original drug. Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation or indication. Upon approval, a drug may be marketed only for the FDA-approved indications in the approved dosage forms. Further clinical trials are necessary to gain approval for the use of the product for any additional indications or dosage forms. In connection with a Section 505 (b)(2) NDA covering ANX-514, ADVENTRX must certify that all applicable Taxotere patents have expired prior to the manufacture, use or sale of ANX-514.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. The Company seeks to improve the performance and safety of existing treatments by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and treatment resistance. More information can be found on the Company's web site at http://www.adventrx.com.

Forward Looking Statement

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, uncertainties, assumptions and other factors that, if they do not materialize or 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 preclinical and clinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical and clinical data suggests or as otherwise anticipated; difficulties or delays in developing, testing, manufacturing and marketing and obtaining regulatory approval for ANX-514, including receiving necessary regulatory approvals for clinical trials of ANX-514 and the potential for automatic injunctions regarding FDA approval of ANX-514 and other challenges by patent holders during the Section 505(b)(2) process; uncertainty under Section 505(b)(2) resulting from legal action against the FDA and the potential that future interpretations of Section 505(b)(2) could delay or prevent the FDA from approving any Section 505(b)(2) NDA; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; patent and non- patent exclusivity covering docetaxel; the risk that ADVENTRX will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones, including funding the continued development of ANX-514; 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 http://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, including as 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©2007 PR Newswire.
All rights reserved

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:3/20/2017)... ... ... SSCI and Whitehouse Laboratories, divisions of Albany Molecular Research, Inc, are looking ... Drug Association (PDA), the New York Interphex Show will open on March 21 and ... 625 exhibitors, the educational and networking opportunities are extremely valuable. INTERPHEX is viewed as ...
(Date:3/20/2017)... New York City, NY (PRWEB) , ... March ... ... pressure vessels and equipment for pharmaceutical and biotech companies, recently announced it will ... Javits Center in New York City. The intelliVessel is controlled by a touch ...
(Date:3/20/2017)... ... March 20, 2017 , ... ... sample preparation methods in order to reduce the impact on instrumentation. ICP-MS is ... area of elemental analysis. , This presentation will discuss the pros and ...
(Date:3/20/2017)... ... March 20, 2017 , ... The fourth annual ... innovating to make an extraordinary impact on peoples’ lives, launches today. Sponsored by ... every 5 weeks and awards thousands in cash prizes to engineers, inventors and tinkerers ...
Breaking Biology Technology:
(Date:3/7/2017)... 2017   HireVue , the leading provider of ... the best talent, faster, today announced the additions of ... and Diana Kucer as Chief Marketing Officer ... team poised to drive continued growth in the company,s ... of record bookings in 2017. "Companies worldwide ...
(Date:3/2/2017)... , March 2, 2017 Summary ... better understand Merck KGaA and its partnering interests and ... https://www.reportbuyer.com/product/3605601/ Description The Partnering Deals and Alliance ... partnering activity of one of the world,s leading life ... prepared upon purchase to ensure inclusion of the most ...
(Date:3/1/2017)... -- Aware, Inc. (NASDAQ: AWRE), a leading supplier of biometrics ... has resigned, effective March 3, 2017, as co-Chief ... Treasurer of Aware citing a desire to retire.  Mr. ... the Board of Directors of Aware. ... co-President, General Counsel has been named Chief Executive Officer, ...
Breaking Biology News(10 mins):