Navigation Links
ADVENTRX Announces CoFactor(R) Phase 2b Clinical Trial Overall Survival Results
Date:6/16/2008

SAN DIEGO, June 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today provided an update with regard to overall survival from its Phase 2b clinical trial of CoFactor for the treatment of first-line metastatic colorectal cancer. Overall survival results in this study have been revised upwards slightly, with the CoFactor/5-FU (5-fluorouracil) arm demonstrating a 14 day improvement in overall survival compared to the leucovorin/5-FU arm.

"In the Phase 2b study, CoFactor was dosed at 60mg/m2 by infusion to provide as unbiased a comparison as possible to leucovorin, which is administered at 200 mg/m2 by infusion over about 2 hours in this setting," stated Evan M. Levine, Chief Executive Officer and President of ADVENTRX. "Even while administering CoFactor over hours instead of the more optimal 2 to 3 minute bolus administration, and at a significantly lower dose of the folate, we were able to demonstrate a numerical advantage with respect to overall survival and progression-free survival with CoFactor plus 5-FU in this study, which is encouraging."

Consistent with its previous guidance, the Company anticipates announcing available interim data from its discontinued Phase 3 trial of CoFactor for the treatment of first line metastatic colorectal cancer later this month. Furthermore, the Company is on track to announce its decision about how to best move forward with its CoFactor program later this month.

About the CoFactor Phase 2b Study

The Phase 2b clinical trial was an international, open-label, randomized, controlled, multicenter study designed to evaluate the safety and efficacy of treatment with CoFactor/5-FU compared to leucovorin/5-FU utilizing an infusional administration in patients with first line metastatic colorectal cancer. Three hundred patients were randomized to receive CoFactor/5-FU or leucovorin/5- FU. The CoFactor/5-FU arm demonstrated comparable overall safety to the leucovorin/5-FU arm. However, the CoFactor/5-FU arm did not demonstrate statistically significant improved safety in the trial's primary endpoint, a reduction in the proportion of patients reporting at least one hematological or gastrointestinal adverse event of grade 3 or greater.

About ANX-510, or CoFactor

CoFactor is a folate-based biomodulator designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU (5-fluorouracil). Compared to leucovorin, CoFactor creates more stable binding between the active form of 5-FU and the target enzyme, thymidylate synthase. CoFactor bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, potentially allowing 5-FU to work more effectively.

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 problems associated with these treatment regimens. More information can be found on ADVENTRX's web site at http://www.adventrx.com.

Forward Looking Statements

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 results of pending clinical trials for CoFactor; unexpected adverse side effects or inadequate therapeutic efficacy of CoFactor; 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; 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; the potential to attract a strategic partner and the terms of any related transaction; the potential for ADVENTRX's product candidates to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; 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 update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.


'/>"/>
SOURCE ADVENTRX Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. ADVENTRX Presents CoFactor Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
2. ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
3. ADVENTRX to Present CoFactor Phase 2 Breast Cancer Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)
4. ADVENTRX to Present ANX-201 Preclinical Data at Keystone Symposia HIV Pathogenesis Conference
5. ADVENTRX Announces Completion of Patient Enrollment in Phase 2 Clinical Trial of CoFactor(R) for the Treatment of Advanced Breast Cancer
6. ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
7. ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
8. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
9. Disc Motion Technologies Announces First Human Implants of True TSMS(TM) Device
10. Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections
11. NicOx Announces Blood Pressure Analysis From 301 Phase 3 Study for Naproxcinod at EULAR
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... April 29, 2016  In the next ten ... shift from systems dependent on CRTs monitors to those ... modality CRT Medical monitors and will automatically sync ... host of foreseeable benefits to this technological advancement, ... modalities have to be replaced in order to ...
(Date:4/29/2016)... 29, 2016 ReportsnReports.com adds ... market research report that provides an overview of ... at various stages, therapeutics assessment by drug target, ... and molecule type, along with latest updates, and ... key players involved in the therapeutic development for ...
(Date:4/29/2016)... , April 29, 2016 ... for Life Sciences, Product Development Capabilities in ... Science Customer Base . Indegene ... today announced the acquisition of Skura Corporation,s life ... leader in adaptive sales enablement technology for life ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... 2016 , ... Since launching its annual volunteer campaign on ... footwear industry, has broken all previous participation records in its first two weeks ... during the months of April and May, the 2016 Footwear Cares initiative is ...
(Date:4/29/2016)... Newport Beach, Calif. (PRWEB) , ... April 29, 2016 , ... ... affect us. An effective way to confront and deal with these stressors is to ... taste bad to be good for you. Risa Groux, a certified Holistic Nutritionist and ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... ... advocating optimistic healthcare awareness and author of best seller "LOVE, MEDICINE and MIRACLES") ... Radio Monday, May 2, 2016 and podcasted thereafter . Dr. Bernie Siegel, ...
(Date:4/29/2016)... Stewart, GA (PRWEB) , ... April 29, 2016 , ... ... Monday, May 16, 2016, at its new location in the Exchange Furniture Mall at ... a raffle for a 50-inch Samsung Smart TV. Plus attendees will have the opportunity ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... won the $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan ... the Michelson People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ ...
Breaking Medicine News(10 mins):