SAN DIEGO, July 1 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) today announced preliminary response rate results from its
discontinued Phase 3 clinical trial of ANX-510, or CoFactor, the Company's
folate-based biomodulator of 5-FU (5 fluorouracil), for the treatment of
first-line metastatic colorectal cancer. The primary endpoint of the study
was progression-free survival, which is expected to mature and be reported
by the Company along with safety data later this year.
Data from the 85 patients treated in the study demonstrated a 39.0%
objective response rate in the CoFactor/5-FU/Avastin(R) experimental arm
compared to a 31.8% objective response rate in the leucovorin/5-FU/Avastin
control arm. The data also demonstrated a 48.8% stable disease rate and
4.8% progressive disease rate in the CoFactor experimental arm compared to
a 38.6% stable disease rate and 15.9% progressive disease rate in the
leucovorin control arm. Objective response rate was measured according to
RECIST criteria and was based on the number of complete responses and
partial responses observed in this study based on investigators'
assessments. In the study, both CoFactor and 5-FU were administered as an
i.v. bolus. Currently, there are 10 patients receiving treatment in this
study, with 6 patients on the CoFactor experimental arm and 4 patients on
the leucovorin control arm.
Based on the data available at this time, the Company intends to
evaluate potential options for the continued development of CoFactor. As
the Company makes progress it anticipates providing updates regarding its
development plans for CoFactor.
"As we evaluate further safety and efficacy data from our Phase 3 trial
and the results of our pharmacokinetic bridging study, we expect to assess
our options for continued development of CoFactor, including potentially
reinitiating discussions with regulatory authorities," stated Evan M.
Levine, Chief Executive Officer and President of ADVENTRX. "Given our
encouraging progress with ANX-530 and ANX-514, our resources are focused
primarily on advancing our later-stage product candidates, which includes
submitting an NDA for ANX-530 and completing our registrational
bioequivalence clinical study for ANX-514," added Mr. Levine.
About the Discontinued Phase 3 Clinical Study
The Phase 3 clinical trial was a randomized, controlled, multicenter
study designed to evaluate the safety and efficacy of CoFactor/5-FU/Avastin
and leucovorin/5-FU/Avastin in patients with first-line metastatic
colorectal cancer. Eighty-nine patients were randomized to either the
leucovorin control arm or the CoFactor experimental arm, with a bolus
regimen of 5-FU (the Roswell Park regimen) and Avastin; eighty-five
patients were treated. The primary endpoint in this study was an
improvement in progression-free survival. Secondary endpoints included
response rate, overall survival and incidence and severity of adverse
events.
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-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 risk that ADVENTRX does not continue the development of
CoFactor, including based on the pharmacokinetic results from ADVENTRX's
pharmacokinetic bridging study, progression-free and overall survival, as
well as final safety, results from ADVENTRX's discontinued Phase 3 study or
revisions to previously announced CoFactor results; the Company's inability
to identify and secure approval from applicable regulatory authorities for
an appropriate, cost-effective development path for CoFactor; the risk that
ADVENTRX will be unable to raise sufficient capital to fund the continued
development of CoFactor or the Company's other product candidates; the
potential to attract a strategic partner for the Company's product
candidates 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; unexpected or a greater than expected number
of expected adverse side effects or inadequate therapeutic efficacy of
CoFactor, regardless of administration method, or ADVENTRX's other product
candidates; 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; 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.
Investor Contact:
ADVENTRX Pharmaceuticals
Ioana C. Hone
858-552-0866
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com
CONTACT:
Investors, Ioana C. Hone of ADVENTRX
Pharmaceuticals, +1-858-552-0866
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