SAN DIEGO, Oct. 25 /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 it presented preclinical results demonstrating that ANX-514, the company’s docetaxel emulsion product candidate, reduced hypersensitivity reactions without impacting pharmacokinetics or antitumor activity when compared to Taxotere(R) (docetaxel). The results were presented at the American Association of Cancer Research (AACR), National Cancer Institute (NCI) and European Organization and Treatment of Cancer (EORTC) International Conference “Molecular Targets and Cancer Therapeutics” in San Francisco on October 25, 2007 by Mark J. Cantwell, Ph.D., vice president, research and development. 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.
“We feel the reduced hypersensitivity reactions associated with ANX-514 would be a benefit to patients and a way to differentiate ANX-514,” stated Evan M. Levine, chief executive officer of ADVENTRX. “We remain focused on initiating a marketing-enabling clinical trial of ANX-514 later this year, pending appropriate regulatory clearances.”
In an established animal model, anaphylactoid clinical reactions were observed following Taxotere administration, including decreased respiration, swelling and tremors. Furthermore, decreases in blood pressure and increases in histamine levels were observed within 10-20 minutes of Taxotere administration. In contrast, hypersensitivity reactions were not observed following administration of ANX-514; specifically, no treatment-related change in blood pressure and no increase in histamine levels were observed. In this crossover design study, even on re-challenge at 3 weeks, hypersensitivity reactions were observed only in the Taxotere treated animals. In two separate studies in different animal species, ANX-514 showed bioequivalent pharmacokinetics to Taxotere. Moreover, in an established in vivo model, ANX-514 demonstrated dose-dependent inhibition of tumor growth with equivalent antitumor activity when compared to Taxotere at equal dose levels.
A copy of the poster presentation is available for download from the “Resources” section of the Company’s web site at http://www.adventrx.com under “Publications”.
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.
ADVENTRX recently received confirmation from the U.S. Food and Drug Administration (FDA) regarding its proposed 505(b)(2) New Drug Application (NDA) regulatory plan for ANX-514. The FDA indicated that data from a single study of approximately 28 patients that demonstrates the bioequivalence of ANX-514 and Taxotere is sufficient clinical data to support filing an NDA.
About Section 505(b)(2)
Section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act (FDCA) allows the Food and Drug Administration (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. To the extent a Section 505(b)(2) applicant is relying on the FDA’s findings for an already-approved drug, the applicant is required to certify to the FDA concerning any patents listed for the approved drug in the FDA’s Orange Book publication, which may include a certification that listed patents are invalid or will not be infringed by the manufacture, use or sale of the new drug.
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 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 preclinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical data suggests or as otherwise anticipated; 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; the FDA’s views on the appropriateness of seeking marketing approval of ANX-514 under Section 505(b)(2); 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, in a timely manner or at all, 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; 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.
CONTACT: Ioana C. Hone of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866
Web site: http://www.adventrx.com/
