Conference Call Scheduled for October 1, 2007 at 1:00 P.M. (Eastern Time);
Simultaneous Webcast at http://www.adventrx.com
SAN DIEGO, Oct. 1 /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 results from its Phase
2b clinical trial of ANX-510, or CoFactor, for the treatment of metastatic
colorectal cancer.
The CoFactor/5-FU (5-fluorouracil) 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.
CoFactor/5-FU Leucovorin/5-FU P-value
N=147 N=148
Patients reporting at least 1
hematological or
gastrointestinal adverse event
of grade 3 or greater 23 10 p<0.05
Hematological 11 7 n/s
Gastrointestinal 12 5 n/s
In addition, no statistically significant differences between the arms
were observed across overall safety and efficacy variables.
"The results of this trial are disappointing in that we were unable to
demonstrate better safety with CoFactor plus 5-FU versus leucovorin plus
5-FU in the infusional setting," stated Evan M. Levine, chief executive of
ADVENTRX. "We will carefully analyze the full set of data and our
assumptions underlying the development of CoFactor for the treatment of
metastatic colorectal cancer in determining the future of this program."
"Beyond CoFactor, we remain focused on completing our
marketing-enabling clinical trial of ANX-530, our vinorelbine emulsion
product candidate, and initiating a marketing-enabling clinical trial of
ANX-514, our docetaxel emulsion product candidate," Mr. Levine continued.
"We expect to announce the results for ANX-530 later this year and, if
positive, to submit an NDA next year. Our financial position, with
approximately $38 million in cash, cash equivalents and short-term
investments, remains strong."
Preliminary selected findings from the Phase 2b trial include:
CoFactor/5-FU Leucovorin/5-FU
Patients reporting at least 1 adverse event of grade 3 or greater (%):
Diarrhea 0 0.7
Nausea 0.7 0
Vomiting 0.7 1.4
Stomatitis 0 1.4
Mucositis 0 0
Anemia 2.0 2.0
Neutropenia 2.7 2.0
Hyperbilirubinemia 2.7 2.0
Neuropathy 0 0
Hand-Foot Syndrome 0.7 0
Patients reporting at least 1 adverse event of any grade (%):
Diarrhea 17.0 17.6
Nausea 17.0 17.6
Vomiting 15.6 12.8
Stomatitis 2.7 2.7
Mucositis 0.7 0.7
Anemia 2.0 7.4
Neutropenia 4.8 3.4
Hyperbilirubinemia 6.1 3.4
Neuropathy 0 0.7
Hand-Foot Syndrome 2.7 1.4
Findings from selected secondary endpoints (intent-to-treat population)
include:
Objective Response Rate 10.7% 13.3%
Median Progression-free Survival (months) 6.3 6.1
Preliminary Median Survival (months) 14.7 14.3
One hundred fifty patients were randomized to each arm. Currently, of
the patients randomized to the CoFactor/5-FU arm, 70 remain alive and, of
the patients randomized to the leucovorin/5-FU arm, 65 remain alive.
This international, open-label, randomized, controlled Phase 2b
clinical trial was designed to evaluate the safety and efficacy of
CoFactor/5-FU compared to leucovorin/5-FU for the treatment of first line
metastatic colorectal cancer. Three hundred patients were randomized to
receive CoFactor/5-FU or leucovorin/5- FU. The primary endpoint was a
reduction in the proportion of patients with at least one grade 3 or
greater toxicity assessment in the category of "Blood/Bone Marrow" or
"Gastrointestinal" adverse events (as defined by the NCI Common Terminology
Criteria for Adverse Events, version 3). Superiority of the CoFactor/5-FU
arm versus the leucovorin/5-FU arm was to be demonstrated by a two-sided
p<0.05 calculated by Fisher's exact test performed on the safety
population. James Cassidy, MD, MBChB, MSc, FRCP, Professor of Oncology and
Head of the Department of Cancer Research in the U.K. Department of Medical
Oncology at the University of Glasgow in Glasgow, Scotland, was the study
chair.
Conference Call Information
ADVENTRX will host a conference call and webcast to discuss the results
today, Monday, October 1, 2007 at 1:00 p.m. Eastern Time (10:00 a.m.
Pacific Time). The conference call may be accessed by dialing (800)
665-0430 for domestic callers and (913) 312-0402 for international callers.
The webcast will be available live via the Internet by accessing ADVENTRX's
web site at http://www.adventrx.com under "Investors." Replays of the
webcast will be available for 30 days, and a phone replay will be available
through October 2, 2007 by dialing (888) 203-1112 and entering the passcode
8640821.
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.
Delivery of CoFactor, compared to delivery of leucovorin, enables more
stable binding of the metabolite 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. In addition to the Phase
2b clinical trial the subject of this press release, CoFactor is being
evaluated in a Phase 3 clinical trial for the treatment of metastatic
colorectal cancer and 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. ADVENTRX
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 risk that ADVENTRX will be unable to raise sufficient
capital to fund the projects necessary to meet its anticipated or stated
goals and milestones, including funding the continued development of
CoFactor, ANX-530 or ANX-514; the risk that preclinical results are not
indicative of the success of subsequent clinical trials and that products
will not perform as preclinical data suggests or as otherwise anticipated;
difficulties or delays in developing, testing, manufacturing and marketing
and obtaining regulatory approval for ADVENTRX's product candidates,
including receiving necessary regulatory approvals for clinical trials of
ANX-514 and the potential for automatic injunctions regarding FDA approval
of ANX-530 and ANX-514 and other challenges by patent holders during the
Section 505(b)(2) process; uncertainty under Section 505(b)(2) resulting
from legal action against the FDA and the potential that future
interpretations of Section 505(b)(2) could delay or prevent the FDA from
approving any Section 505(b)(2) NDA; the potential for regulatory
authorities to require additional preclinical work or other clinical
requirements to support regulatory filings; patent and non-patent
exclusivity covering vinorelbine and docetaxel; the timing and success of
clinical trials; 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
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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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