SAN DIEGO, April 5 /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, today announced that it has entered into an agreement with Hyaluron Contract Manufacturing to manufacture ANX-514 (docetaxel emulsion) for preclinical and clinical studies.
“We are excited about the on-going development of ANX-514,” said Evan M. Levine, Chief Executive Officer of ADVENTRX. “ANX-514 fits well with our approach of developing less toxic drugs and improving patient care. We anticipate seeking guidance from the Food and Drug Administration with regard to a 505(b)(2) regulatory path for ANX-514, and pending appropriate clearances, initiating a marketing-enabling clinical trial of ANX-514 later this year.”
ADVENTRX is conducting preclinical pharmacokinetic testing of ANX-514 to compare this product candidate with the approved version of the product, marketed under the brand name Taxotere(R). The Company currently plans to seek guidance from the FDA in 2007 with respect to the appropriateness of a Section 505(b)(2) NDA regulatory path for ANX-514.
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a product marketed under the brand name Taxotere. ANX-514 is designed to eliminate the need for multi-day immunosuppressant premedication. 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 allergic 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 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. Section 505(b)(2) of the FDCA was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Act. This procedure 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.
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. The Company’s lead product candidate, ANX-510 (CoFactor), is in Phase 3 and Phase 2b clinical trials for the treatment of metastatic colorectal cancer, as well as in a Phase 2 clinical trial for the treatment of advanced breast cancer. More information can be found on the Company’s web site at http://www.adventrx.com.
About Hyaluron Contract Manufacturing
Hyaluron Contract Manufacturing (HCM) is a leader in aseptic contract manufacturing of filled liquid parenterals and medical devices. Since 1999, HCM has been offering its customers-from newly established firms to large-scale commercial enterprises-innovative and unique solutions to all their aseptic formulation/fill needs. At the core of HCM’s business is a commitment to quality, regulatory compliance and on-time delivery as well as courteous and professional communication. HCM is headquartered in Burlington, MA. For further information, visit www.hyaluron.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. Such forward-looking statements are made based on management’s current expectations and beliefs and should not be regarded as a statement or representation by ADVENTRX that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: Hyaluron’s ability to comply with current good manufacturing practices or otherwise supply materials suitable for use in human clinical trials; Hyaluron’s ability to supply materials in quantities and on timelines sufficient to meet ADVENTRX’s needs; the FDA’s views on the appropriateness of ADVENTRX seeking marketing approval for ANX- 514 under Section 505(b)(2) of the FDCA; the ability of ADVENTRX to secure meetings with the FDA on favorable timelines and the outcome of those meetings; 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 ability to timely receive necessary regulatory approvals for ADVENTRX’s current and anticipated preclinical and clinical trials; 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; 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. All forward-looking statements are qualified in their entirety by this cautionary statement and ADVENTRX assumes no obligation 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 of ADVENTRX Pharmaceuticals,+1-858-552-0866; or Media, Amy Martini of WeissComm Partners,+1-212-301-7223, for ADVENTRX
Web site: http://www.adventrx.com/
Company News On-Call: http://www.prnewswire.com/gh/cnoc/comp/920134.html/
