Navigation Links
ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
Date:11/16/2007

SAN DIEGO, Nov. 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced positive results from its marketing-enabling clinical study of ANX-530 (vinorelbine emulsion). Pharmacokinetic equivalence, the primary endpoint of the study, was observed between ANX-530 and Navelbine(R), the reference product, in patients with advanced cancer potentially sensitive to vinorelbine. Equivalence was demonstrated by a statistical comparison of both the areas under the curve (AUC) and maximum plasma concentrations (Cmax). The Company anticipates safety and full clinical results will be available during the first quarter of 2008. Results from this study will be submitted for presentation at an appropriate medical conference.

"We're very pleased with these results, which we believe will provide sufficient clinical data to support a Section 505(b)(2) New Drug Application," said Evan M. Levine, chief executive officer of ADVENTRX. "We have a meeting scheduled with the FDA in December to discuss our commercial manufacturing plans. After we receive the FDA's written comments, we intend to provide an update regarding our NDA timeline for ANX-530."

ANX-530 is a novel emulsion formulation of vinorelbine. Vinorelbine, marketed under the brand name Navelbine(R), also available as generic vinorelbine, is an anti-cancer agent approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. Worldwide annual sales of Navelbine and generic vinorelbine in 2006 were approximately $200 million.

The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530
'/>"/>

SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
2. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
3. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
4. ERBITUX(R) Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study
5. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
6. Tezampanel Meets Primary Endpoint in Phase IIb Clinical Trial in Acute Migraine Headache
7. A Phase II, Randomized, Double Blind, Placebo-Controlled Dose-Escalating Study, Meets the Clinical Endpoints of MTR106 Tablets During the Treatment of Acute Migraine Attacks Without Aura in Females
8. New Research May Lead to Earlier Diagnosis and Treatment of Primary Biliary Cirrhosis in Families
9. Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
10. Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia
11. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... , Sept. 22, 2014 /PRNewswire/-- CANTEL MEDICAL CORP. (NYSE: ... and fiscal 2014 ended July 31, 2014 on Monday, September ... to discuss the results at 11:00 AM ET. Participating in ... Andrew A. Krakauer , President and CEO; Jorgen ... A. Sheldon , Senior Vice President, CFO and Treasurer; and ...
(Date:9/22/2014)... , Sept. 22, 2014  Inovio Pharmaceuticals, Inc. ... has initiated a phase I clinical trial in ... the safety, tolerability, and immunogenicity of INO-3106. This ... causes most aerodigestive cancers. Aerodigestive cancers ... cords, and parts of the esophagus and windpipe. ...
(Date:9/22/2014)... , Sept. 22, 2014  Seres Health, a clinical-stage ... the human microbiome, today announced that it has been ... Fierce 15 biotechnology companies, designating it as one of ... "Amid a great deal of ain,t-it-cool ... focus and commitment to practical therapeutic development," says ...
Breaking Medicine Technology:Cantel Medical Corp. To Hold Conference Call To Discuss Results For Its Fourth Quarter And Fiscal 2014 Ended July 31, 2014 2Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 2Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 3Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 4Seres Health Named a "Fierce 15" Biotech Company for 2014 2
... Jan. 4, 2012 /PRNewswire/ -- CryoLife, Inc. (NYSE: ... company focused on cardiac and vascular surgery, announced today ... the position of Vice President, Research and Development; and ... Vice President, Market Development Surgical Adhesives and Starch Medical ...
... /PRNewswire-Asia/ -- The 2011 Medical Korea Awards ceremony was ... the awards ceremony, 10 outstanding medical tourism service providers ... medical tourism agencies, designated as ,first movers, in the ... Yonsei Severance Hospital (General Director: Park Yong-won) won this ...
Cached Medicine Technology:CryoLife Enhances Management Team with Promotions 2CryoLife Enhances Management Team with Promotions 3CryoLife Enhances Management Team with Promotions 4CryoLife Enhances Management Team with Promotions 5Medical Korea Offers 2011 Awards to Top Medical Tourism Service Providers (Institutions) 2
(Date:9/22/2014)... Oaks, CA (PRWEB) September 22, 2014 ... now offering a special offer for Invisalign. Invisalign is ... smiles and correct bite problems. Typical pricing can vary ... and the number of aligners that are needed. During ... for just $4,495. , About a fifth of the ...
(Date:9/22/2014)... The invitation only Summit held on ... industry executives and thought leaders from major fitness ... Fitness, and Xsport Fitness. Also in attendance were ... agencies and private equity investors representing over 1,500 ... The Summit highlighted best practices for solving new ...
(Date:9/22/2014)... -- New research raises doubts about the possible benefits ... cancer who used e-cigarettes along with traditional cigarettes were ... the devices, a Memorial Sloan Kettering study found. These ... likely -- to have quit smoking than patients who ... Sept. 22 in Cancer , involved almost 1,100 ...
(Date:9/22/2014)... 2014 At the 10th Clinton ... Nutrition Partnership (SNP) announced the successful launch of ... Cardiovascular Risk Reduction Program for Women. The announcement ... mitigate their risk of heart disease through a ... plan for addressing significant global challenges made by ...
(Date:9/22/2014)... NY (PRWEB) September 22, 2014 Tristar ... American icon Jack LaLanne, best known as the 'Godfather ... "ANYTHING IS POSSIBLE" premiering September 24th at the ... documentary gives an inspiring insight behind the man whose ... benefits of fitness and nutrition. The name of the ...
Breaking Medicine News(10 mins):Health News:Thousand Oaks Cosmetic Dentist, Sharon Shamoiel DDS, Is Now Offering a Special on Invisalign 2Health News:Motionsoft Concludes Inaugural 2014 Technology Summit 2Health News:Motionsoft Concludes Inaugural 2014 Technology Summit 3Health News:E-Cigarettes Don't Help Cancer Patients Quit Smoking: Study 2Health News:At 2014 Clinton Global Initiative Annual Meeting, Seafood Nutrition Partnership Announces Pilot Program to Reduce Women’s Heart Disease Risks 2Health News:At 2014 Clinton Global Initiative Annual Meeting, Seafood Nutrition Partnership Announces Pilot Program to Reduce Women’s Heart Disease Risks 3Health News:At 2014 Clinton Global Initiative Annual Meeting, Seafood Nutrition Partnership Announces Pilot Program to Reduce Women’s Heart Disease Risks 4Health News:Tristar Products Premieres The Jack LaLanne Documentary at TriBeCa Film Center in New York City 2Health News:Tristar Products Premieres The Jack LaLanne Documentary at TriBeCa Film Center in New York City 3
... to directly measure the brain,s temperature without inserting a probe ... get the brain,s precise temperature with a device the diameter ... to findings presented May 1 at the annual meeting of ... first time that anyone has presented data on the brain ...
... Johns Hopkins have shown in laboratory experiments in mice ... inside the heart,s muscle cells blunts the most serious ... These include heart muscle enlargement, scar tissue formation ... Specifically, the Johns Hopkins team found that their intervention ...
... -- Children born to women exposed to bisphenol A (BPA) ... to experience wheezing early in life, according to a new ... many hard plastic food containers, water bottles and the lining ... in more than 90 percent of the U.S. population, the ...
... News) -- A new study finds that different patterns of ... arterial stiffness, which is associated with cardiovascular disease. Stiff ... and are also associated with a buildup of plaque in ... to a heart attack. In this study, Dr. Danny ...
... reserve" in early-onset Alzheimer,s disease (AD) and PET-CT examinations ... patients. "Although early-onset Alzheimer,s dementia is quite ... carry the diagnosis," said Dr. Jacob Richard Hodge, lead ... Rochester, Minn. "Symptoms are often unexpected and support networks ...
... have discovered a link between low levels of vitamin D ... May 1 at the annual meeting of the Pediatric Academic ... play an important role in anemia. Anemia, which occurs ... is diagnosed and tracked by measuring hemoglobin levels. Symptoms of ...
Cached Medicine News:Health News:Researchers develop device to measures brain temperature non-invasively 2Health News:Animal studies reveal new route to treating heart disease 2Health News:Animal studies reveal new route to treating heart disease 3Health News:Mom's Exposure to Plastics Chemical Tied to Baby's Wheeze 2Health News:PET-CT exams help identify cognitive reserve in early-onset Alzheimer's disease 2Health News:Low vitamin D in kids may play a role in anemia 2
A simple solution to hand assisted laparoscopic surgery....
GelPort hand access laparoscopy combines the patient outcomes of minimally invasive surgery with the speed and precision of open surgery....
... HandPort Systems non-adhesive sealing method ... Laparoscopic Surgrery (HALS) procedures, allowing ... and palpate throughout. Because HALS ... 6 cm, patients experience less ...
The CPAP TREND 110 delivers performance with quiet operation. Can be used together with the SomnoPlus CPAP Mask and AquaTrend Heated Humidifier....
Medicine Products: