Navigation Links
ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Date:8/19/2007

SAN DIEGO, Aug. 16 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for ANX-510, or CoFactor(R) injection, which is currently being investigated in a pivotal Phase 3 study, with 5-fluorouracil (5-FU) and bevacizumab for the initial treatment of metastatic colorectal cancer. CoFactor is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU.

"The FDA's fast track designation represents a significant step towards bringing CoFactor to market as rapidly as possible," stated Evan M. Levine, chief executive officer of ADVENTRX. "We look forward to working closely with the FDA to expedite the review and approval process for CoFactor."

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track status enables a sponsor to have more frequent and timely communication and meetings with the FDA regarding product development plans and may also result in eligibility for priority review of New Drug Applications. Fast track designation does not apply to a product alone but a combination of a product and specific indication.

ADVENTRX is currently conducting a 1,200-patient, Phase 3 clinical study of CoFactor for the treatment of metastatic colorectal cancer across the U.S. and in Europe. Patients are randomized to two arms containing either CoFactor or leucovorin, each in combination with the widely used cancer chemotherapy regimen of 5-FU and bevacizumab (Avastin(R)). The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events. The protocol and planned analysis were developed with and accepted by the FDA under a Special Protocol Assessment.

About ANX-510, or CoFactor

CoFactor is a folate-based biomodulator drug 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. In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. 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.

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 and bioavailability, excessive toxicity and treatment resistance. 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 potential for CoFactor to receive regulatory approval for metastatic colorectal cancer or other indications on a timely basis or at all; the uncertain process of seeking regulatory approval; difficulties or delays in developing, testing, manufacturing and marketing of CoFactor; 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 ability to timely enroll subjects in ADVENTRX's current and anticipated clinical trials; the timing and success of clinical trials; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; adverse side effects or inadequate therapeutic efficacy of CoFactor; the risk that preclinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical and clinical data suggest 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. ADVENTRX does not intend to 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.


'/>"/>
SOURCE ADVENTRX Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

Related biology technology :

1. Speaker announces business members of IT Task Force
2. Doyle announces technology tax credits for Berbee
3. Doyle announces new energy, global warming policies
4. Doyle announces $80M renewable energy strategy
5. GE announces first installation of Discovery VCT
6. UWM announces winners of RGI awards
7. Third Wave announces two senior management appointments
8. Mirus announces new method for making antibodies
9. Merge announces sofware updates, upcoming acquisition
10. Small Tree announces ethernet solution for Apple Xserv G5
11. TEKLYNX International announces new RFID software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... San Diego, CA (PRWEB) , ... June 27, 2016 , ... ... mClinical solutions for clinical trials, announced today the Clinical Reach Virtual Patient ... and their care circle with the physician and clinical trial team. , Using the ...
(Date:6/27/2016)... PHILADELPHIA , June 27, 2016  Liquid ... today announced the funding of a Sponsored Research ... study circulating tumor cells (CTCs) from cancer patients.  ... changes in CTC levels correlate with clinical outcomes ... therapies. These data will then be employed to ...
(Date:6/24/2016)... DIEGO , June 24, 2016 ... more sensitively detects cancers susceptible to PARP inhibitors ... circulating tumor cells (CTCs). The new test has ... HRD-targeted therapeutics in multiple cancer types. ... targeting DNA damage response pathways, including PARP, ATM, ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering ... retention in this eBook by providing practical tips, tools, and strategies for clinical ...
Breaking Biology Technology:
(Date:6/27/2016)... -- Research and Markets has announced the addition of ... their offering. The report forecasts ... grow at a CAGR of 12.28% during the period 2016-2020. ... market analysis with inputs from industry experts. The report covers the ... report also includes a discussion of the key vendors operating in ...
(Date:6/22/2016)... June 22, 2016  The American College of Medical Genetics ... Executive Magazine as one of the fastest-growing trade shows ... at the Bellagio in Las Vegas . ... percentage of growth in each of the following categories: net ... and number of attendees. The 2015 ACMG Annual Meeting was ...
(Date:6/22/2016)... 2016   Acuant , the leading ... has partnered with RightCrowd ® to ... Management, Self-Service Kiosks and Continuous Workforce Assurance. ... functional enhancements to existing physical access control ... with an automated ID verification and authentication ...
Breaking Biology News(10 mins):