SAN DIEGO, Sept. 10 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. 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.
ADVENTRX Pharmaceuticals, Inc.
CONTACT: Investors, Ioana C. Hone, +1-858-552-0866, for ADVENTRXPharmaceuticals, Inc.
Web site: http://www.adventrx.com/
Company News On-Call: http://www.prnewswire.com/comp/920134.html /
