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.
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Related links:
http://www.adventrx.com
http://www.prnewswire.com/comp/920134.html /
CONTACT:
Investors - Ioana C. Hone of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866
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