ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clin...(f a single dose of ANX-530 was a seconda...),Health

Date:5/16/2008

f a single dose of ANX-530 was a secondary objective. In the first week, patients were dosed with either ANX-530 or Navelbine, and after a washout period, were dosed with the opposite drug during the second week of treatment. Pharmacokinetic equivalence, the primary endpoint of the study, was observed between ANX-530 and Navelbine.

ADVENTRX intends to submit to the U.S. Food and Drug Administration (FDA) a Section 505(b)(2) NDA for ANX-530 around the end of 2008.

About ANX-530 (vinorelbine emulsion)

ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non- small cell lung cancer and advanced or metastatic breast cancer. Worldwide sales of Navelbine and generic formulations of vinorelbine in 2006 were in excess of $200 million.

Navelbine and its generic equivalents are often associated with injection site reactions, including phlebitis, erythema and pain at the site of injection. Studies have shown these reactions occur in approximately one-third of patients, with 5% of the reactions categorized as severe. ANX-530 is designed to reduce the incidence and severity of these injection site reactions. The Company's formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that is designed protect the venous endothelium during administration into a peripheral vein, thereby reducing irritation associated with administration of the drug.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer and infectious disease. The Company seeks to improve the performance and commercial potential of existing treatments by addressing p
'/>"/>

SOURCE ADVENTRX Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5
Related medicine technology :

1. ADVENTRX to Present CoFactor Phase 2 Breast Cancer Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
2. ADVENTRX to Present ANX-201 Preclinical Data at Keystone Symposia HIV Pathogenesis Conference
3. ADVENTRX Announces Completion of Patient Enrollment in Phase 2 Clinical Trial of CoFactor(R) for the Treatment of Advanced Breast Cancer
4. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
5. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
6. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
7. Medivation Announces Presentation of MDV3100 Clinical Data in Patients With Castration-Resistant Prostate Cancer at 44th American Society of Clinical Oncology Annual Meeting
8. BiPar Sciences Announces Clinical Data Presentations on Lead PARP Inhibitor, BSI-201, at 40th American Society of Clinical Oncology Annual Meeting
9. IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Access Program
10. Biopure Announces Publication of Phase II Proof-of-Concept Coronary Trial
11. Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization