ADVENTRX Announces Positive Efficacy and Safety Results from CoFactor Phase II Clinical Trial
January 30 2006 - 6:00AM
PR Newswire (US)
Increased Clinical Benefit with Low Toxicity Reported in Patients
SAN DIEGO, Jan. 30 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) today announced that it presented
positive efficacy and safety data from its Phase II multi-center
CoFactor(TM) clinical trial at the 2006 Gastrointestinal Cancers
Symposium in San Francisco. Objective results from an independent
radiology organization concluded there was an overall clinical
benefit of 85%. The Company also reported longer than expected time
to tumor progression (TTP), with no drug-related grade 3 or grade 4
gastrointestinal or hematological toxicities. These and other
findings from a blinded, expert assessment of radiographical tumor
stabilization and regression data were included in the
presentation. The Company contracted the independent radiology
organization to ensure the objectivity and integrity of the Phase
II clinical trial response data. "We are very encouraged by the
findings of the independent reviewers. The high level of activity
and low toxicity of CoFactor plus 5-fluorouracil (5-FU) suggests
that this combination may prove useful as an initial treatment for
metastatic colorectal cancer, especially among patients who would
benefit from minimizing toxicity," said Evan M. Levine, president
and CEO for ADVENTRX. "These results give us added confidence as we
proceed to our Phase III pivotal study." Objective,
third-party-confirmed tumor response results from Phase II CoFactor
plus 5-FU trial: * Third-party radiological assessments established
a clinical benefit of 85% following treatment with CoFactor and
5-FU, a higher outcome than the Company reported previously. The
Company previously reported a clinical benefit of 65% as assessed
by the clinical site investigators. Clinical benefit is defined as
the percentage of patients on study drug whose tumors shrunk or
stabilized. * The primary endpoint for the study, objective
response, as determined by blinded third-party radiology
assessment, exceeded the 25% target originally established for the
trial. The reviewers determined that 35% of patients achieved an
objective response and 9% of patients exhibited a minor response
with CoFactor and 5-FU. Objective response is defined as those
patients having complete or partial tumor responses and minor
response is defined as a tumor reduction of less than 50% of total
tumor size. A complete response is a complete disappearance of the
tumor and a partial response is at least a 50% reduction in total
tumor size. These measurements were confirmed by a repeat MRI or CT
scan performed no less than four weeks after the criteria for
response are first met, as defined by World Health Organization
(WHO) criteria. * Forty-one percent of patients exhibited stable
disease and 15% exhibited progressive disease. Stable disease is no
evidence of response (CR, PR, or MR) or progression; and
progressive disease is at least a 25% increase in tumor size at the
end of the treatment cycle, as measured by CT or MRI scans. "The
audit of our primary efficacy endpoint by a team of independent
experts, operating under a pre-defined and quality-assured
procedure to ensure the integrity of the data, has corroborated the
findings of the clinical investigators, suggesting that CoFactor
with 5-FU may be a highly effective therapy for patients with
metastatic colorectal cancer," commented James Merritt, MD, chief
medical advisor for ADVENTRX. "By historical comparison, the
published response rates for IV bolus leucovorin plus 5-FU
administered in a multi-institutional setting have averaged only
about 10-20%, compared to 35% which was observed in this CoFactor
Phase II study." Time to tumor progression and safety results from
the Phase II CoFactor plus 5-FU trial: * Time to tumor progression
(TTP), a secondary endpoint of the study, was reported to have
reached 163 days, or greater than 5.4 months, surpassing the
Company's expectations. TTP is defined as the time from the start
of treatment until objective tumor progression. The determination
for TTP is given as a median value based on Kaplan-Meier estimates.
* Median survival, another secondary endpoint of the study, could
not be reported at this time since more than 50% of the patients on
the study are still alive. "Importantly, the response rate and time
to tumor progression numbers have surpassed previous published
values from multiple institutional studies using leucovorin and
5-FU, including the registration trials for irinotecan and
capecitabine, for which the CoFactor Phase II time to tumor
progression was approximately 25% longer," added Dr. Merritt.
CoFactor plus 5-FU regimen well tolerated: * No grade 3 or 4
drug-related hematological toxicities were recorded for patients
during the trial and there were no grade 3 or 4 gastrointestinal
toxicity events related to the CoFactor/5-FU treatment regimen,
demonstrating that the treatment was well tolerated. Toxicity
grades were determined in accordance with the National Cancer
Institute's Common Terminology Criteria for Adverse Events grading
system. "CoFactor plus 5-FU helped stabilize the overwhelming
majority of these patients and did so with a minimum of serious
hematological or gastrointestinal toxicity," commented Joan M.
Robbins, Ph.D. chief scientific officer and executive vice
president for ADVENTRX. "These findings further support the
development of CoFactor in chemotherapy regimens that utilize 5-FU.
While we have not reached a median survival value, we currently
plan to announce that value and related data after they become
determinable." The abstract "5,10-methylenetetrahydrofolic acid
with 5-fluorouracil as first line treatment in metastatic
colorectal cancer: a phase II study" was presented by Tony Reid,
M.D., Ph.D., Associate Professor, Director Gastrointestinal
Malignancy Program, Department of Hematology/Oncology at the
University of California San Diego (UCSD) and principal
investigator for the Phase II CoFactor trial. About the Phase II
CoFactor trial The Phase II clinical trial is an open label, single
arm Simon two-stage study design to assess the safety and efficacy
of CoFactor plus 5-FU as a first line treatment of metastatic
colorectal cancer. Patients enrolled in the trial had performance
status ECOG 0-2 and measurable metastatic colorectal cancer, with
or without prior adjuvant chemotherapy including 5-FU/leucovorin
but no prior chemotherapy for metastatic disease. Patients may
receive more than two cycles each consisting of CoFactor 60 mg/m2
and 5-FU 450 mg/m2 (weekly IV bolus) for six consecutive weeks,
followed by a 14 day rest period, which is defined as a cycle. The
trial is being conducted in the U.S. and Europe under a U.S.
investigational new drug application. About CoFactor CoFactor
(ANX-510) is a folate-based biomodulator drug being developed to
enhance the activity and reduce associated toxicity of the widely
used cancer chemotherapeutic 5-fluorouracil (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 chemical pathway required by leucovorin to
deliver the active form of folate, allowing 5-FU to work more
effectively. This improves 5-FU performance and lowers toxicity. A
Phase IIb randomized controlled clinical trial is ongoing to
evaluate CoFactor with 5-FU as a first line treatment of metastatic
colorectal cancer. The Company has received clearance under a
special protocol assessment from the US Food and Drug
Administration (FDA) to begin a CoFactor Phase III pivotal clinical
trial for metastatic colorectal cancer, which is currently planned
to begin patient dosing in Q1 2006. About ADVENTRX ADVENTRX
Pharmaceuticals is a biopharmaceutical research and development
company focused on introducing new technologies for anticancer and
antiviral treatments that surpass the performance and safety of
existing drugs, by addressing significant problems such as drug
metabolism, toxicity, bioavailability and resistance. More
information can be found on the Company's Web site at
http://www.adventrx.com/. Forward Looking Statement This press
release contains forward-looking statements, within the meaning of
the "safe harbor" provisions of the Private Securities Litigation
Reform Act of 1995, regarding ADVENTRX. Such statements are made
based on management's current expectations and beliefs. Actual
results may vary from those currently anticipated based upon a
number of factors, including uncertainties inherent in the drug
development process, the timing and success of clinical trials, the
validity of research results, and the receipt of necessary
approvals from the FDA and other regulatory agencies. For a
discussion of such risks and uncertainties, which could cause
actual results to differ from those contained in the
forward-looking statements regarding ADVENTRX, see the section
titled "Risk Factors" in ADVENTRX's last quarterly report on Form
10-Q, as well as other reports that ADVENTRX files from time to
time with the Securities and Exchange Commission. All
forward-looking statements regarding ADVENTRX are qualified in
their entirety by this cautionary statement. ADVENTRX undertakes no
obligation to release publicly any revisions, which may be made to
reflect events or circumstances after the date hereof. DATASOURCE:
ADVENTRX Pharmaceuticals, Inc. CONTACT: Andrea Lynn of ADVENTRX
Pharmaceuticals, +1-858-552-0866 Web site: http://www.adventrx.com/
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