Navigation Links
ADVENTRX Announces Positive Data From Preclinical Pharmacokinetic,Testing of ANX-514 (Docetaxel Emulsion)

tere induced an anaphylactoid type reaction consistent with hypersensitivity reactions, including acute increases in blood histamine levels and decreased blood pressure. In contrast, no hypersensitivity reactions, including no elevations in histamine levels and no changes in blood pressure were observed following dosing with ANX-514.

ADVENTRX is continuing to conduct additional preclinical pharmacokinetic testing of ANX-514 to compare this product candidate with the approved version of the product, marketed under the brand name Taxotere. The Company currently plans to seek guidance from the FDA with respect to the appropriateness of a Section 505(b)(2) NDA regulatory path for ANX-514, and pending agreement on clinical protocol design with the FDA, initiate a marketing-enabling clinical trial of ANX-514 in 2007.

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. 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 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
'"/>




Page: 1 2 3 4 5

Related medicine technology :

1. ADVENTRX to Present CoFactor Multiagent Therapy Data at AACR Annual Meeting
2. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
Post Your Comments:
(Date:9/30/2014)... NEW YORK , Sept. 30, 2014 ... stage. Growing ageing population and rise in the incidence ... of chronic wounds and in affordability of better quality ... Chinese wound care market. Universal coverage of public health ... products would further stimulate demand. Based on the findings ...
(Date:9/30/2014)... , Sept. 30, 2014 BioStructures, LLC ... American Association of Tissue Banks (AATB), it was ... Executive Officer. Accreditation follows an intensive ... specially trained AATB inspector.  It establishes that the ... the facility meets or exceeds the standards set ...
(Date:9/30/2014)... , Sept. 30, 2014  Proteomics is a ... a new report from Kalorama Information.  The healthcare market ... occurred in proteomics in the past two years.  ... agreements between private proteomic companies and academic institutions, ... novel proteomics innovator companies.  Kalorama observed the industry ...
Breaking Medicine Technology:China Wound Care Market 2China Wound Care Market 3Biostructures, LLC Earns AATB Accreditation 2Report: Race for Proteomics Knowledge Spurs Investment and Partnerships 2Report: Race for Proteomics Knowledge Spurs Investment and Partnerships 3
(Date:9/30/2014)... Maryland-led research team has been awarded a three-year ... Health (NIH) to develop new imaging technologies and ... of how large networks of neurons in the ... will help researchers identify the precise interactions between ... decision-making and speaking, and alterations in these interactions ...
(Date:9/30/2014)... Charlotte, N.C. (PRWEB) September 30, 2014 ... as an option to help diabetics curb their sweet ... journal Nature this September, suggests that zero-calorie ... for type 2 diabetes. , The Weizmann Institute ... when they fed artificial sweeteners to mice, the mice ...
(Date:9/30/2014)... FL (PRWEB) September 30, 2014 Regenerative ... to two new clinics in Nashville, Tennessee. RMS welcomes ... Apnea Institute, and the expansion of a new treatment ... introduction of the Sleep Apnea Institute to Nashville, the ... suffer from sleep apnea: both diagnosed and undiagnosed. With ...
(Date:9/30/2014)... -- Medicare should cover low-dose computed tomography lung cancer ... a coalition of more than 60 patient and medical ... Cancer Alliance, the Society of Thoracic Surgeons, the American ... American Society of Clinical Oncology, made its point in ... Medicare & Medicaid Services (CMS). Such screening reduces ...
(Date:9/30/2014)... IL (PRWEB) September 30, 2014 Healthcare ... at the National Association of Health Advocacy Consultants (#NAHAC) ... Healthcare Advocacyā€¯ (#NAHAC14) to be held October 30th - ... its debut at NAHAC14: Standards and Best Practices for ... grows into a profession, advocates have needed a set ...
Breaking Medicine News(10 mins):Health News:UMD receives inaugural BRAIN Initiative Award 2Health News:Artificial Sweeteners May be Linked to Greater Diabetes Risk 2Health News:Regenerative Medicine Solutions Expanding 2Health News:Groups Call for Medicare Coverage of Lung Cancer Screening 2
... ... tidbits people are learning about their ancestors is not just trivia. This information is highly ... understanding their familial and ancestral past. , ... Doylestown, PA (PRWEB) March 13, 2010 -- Noted author Donna Evans Strauss ...
... (Nasdaq: SIAL ) today announced that it has entered into an agreement with Pfizer under which Sigma-Aldrich will sell approximately 100 Pfizer-developed small ... ... , , ... ...
... 19 year olds and to those currently not in employment in a bid to increase awareness of safety at work. , ... , , ... ... ...
... 15, 2010 The Autism Consortium, an innovative research, ... enhancing clinical care for families with autism spectrum disorders ... study of genetic testing methods for autism spectrum disorders ... early online release in their eFirst pages today and ...
... AllegroMedical.com, ... meaning that just under 13 years, it has served more than a million customers nationwide. ... (Vocus) March 14, 2010 ... website launched in 1997. The first company to sell medical supplies online, it has grown ...
... its kind to date using cardiac computed tomography angiography, ... coronary artery disease are at higher risk of developing ... Henry Ford Hospital researchers say. Researchers analyzed the ... computed tomography angiography and found that those with a ...
Cached Medicine News:Health News:Author Proves What Celebrities are Learning in "Who Do You Think You Are?" is More Important Than They Realize 2Health News:Sigma-Aldrich Reaches Agreement to Sell Pfizer's Bioactive Small Molecule Compounds 2Health News:Sigma-Aldrich Reaches Agreement to Sell Pfizer's Bioactive Small Molecule Compounds 3Health News:Sigma-Aldrich Reaches Agreement to Sell Pfizer's Bioactive Small Molecule Compounds 4Health News:Sigma-Aldrich Reaches Agreement to Sell Pfizer's Bioactive Small Molecule Compounds 5Health News:British Safety Council Offers Free Health and Safety Qualifications 2Health News:Autism Consortium study in Pediatrics shows CMA finds more genetic abnormalities than current tests 2Health News:Autism Consortium study in Pediatrics shows CMA finds more genetic abnormalities than current tests 3Health News:Autism Consortium study in Pediatrics shows CMA finds more genetic abnormalities than current tests 4Health News:Online Medical Supplies Superstore Ships 1 Millionth Order 2Health News:Family history is strong predictor of obstructive coronary artery disease using CCTA 2
... line of Personal Catheters® ... you would choose for ... configurations - standard, antibacterial, ... - are based on ...
... It's easy on delicate ... design and hydrophilic coating provide ... lubricating gel. It's easy to ... the catheter with its own ...
... line of Personal Catheters® ... you would choose for ... configurations - standard, antibacterial, ... - are based on ...
... Medical's line of Personal ... catheters you would choose ... product configurations - standard, ... hydro - are based ...
Medicine Products: