ADVENTRX CoFactor Phase IIb Trial Surpasses 50% Enrollment Milestone
February 14 2006 - 2:00PM
PR Newswire (US)
CoFactor Clinical Update Announced at BIO CEO SAN DIEGO, Feb. 14
/PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX)
announced a CoFactor(TM) clinical development update at the BIO CEO
conference today in New York. The Company announced patient
recruitment has surpassed the half-way point in the CoFactor
multi-national Phase IIb clinical trial for metastatic colorectal
cancer which was initiated in May 2005. The Company also announced
an update regarding its planned Phase III clinical studies for
CoFactor. The first Phase III study will evaluate CoFactor in the
first-line treatment of metastatic colorectal cancer. The second
proposed Phase III study would evaluate CoFactor in a third-line
setting for advanced breast cancer. CoFactor (ANX-510) is a
folate-based biomodulator being developed to enhance the activity
and to reduce the toxicity of the widely used chemotherapy drug,
5-fluorouracil (5-FU). "We are pleased that patient enrollment for
the CoFactor Phase IIb clinical trial is progressing rapidly," said
Evan M. Levine, ADVENTRX president and CEO. "We look forward to
continuing to recruit for the Phase IIb and to initiating patient
dosing for the CoFactor Phase III pivotal clinical trial in March
2006." CoFactor Phase IIb Clinical Trial Design for First-line
Treatment of Metastatic Colorectal Cancer: The Phase IIb clinical
trial is a 300-patient, multi-national parallel group study in
patients treated first line for metastatic colorectal cancer. The
trial is designed to detect a reduction in the frequency of grade 3
or grade 4 hematological or gastrointestinal toxicities. Patients
are being randomized to one of two arms containing either CoFactor
or leucovorin, each in combination with 5-FU. All patients will
receive a biweekly infusional regimen consisting of an initial dose
of 400mg/m2 of 5-FU followed by 600 mg/m2 of 5-FU via a 22-hour
infusion on days 1 and 2. The study arm will include 60mg/m2 of
CoFactor and the control arm will include 200mg/m2 of leucovorin.
Tumor assessments are scheduled to occur every eight weeks. The
Company will also assess secondary endpoints of response rate, time
to tumor progression, and survival. The study is being conducted at
sites in Europe and India. Professor James Cassidy, M.D., 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, is the study chair for
the trial. CoFactor Phase III Clinical Trial Design for First-line
Treatment of Metastatic Colorectal Cancer: The Phase III clinical
trial in patients treated first line for metastatic colorectal
cancer is planned to be a 1200 patient, randomized parallel group
trial. Patients will be equally randomized to two arms containing
either CoFactor or leucovorin, each in combination with 5-FU and
bevacizumab (Avastin(R)). All patients will receive a regimen
containing 500mg/m2 of 5-FU via weekly bolus and a biweekly
infusion of 5mg/kg of Avastin. The study arm will include 60mg/m2
of CoFactor and the control arm will include 500mg/m2 of
leucovorin. The study is powered to detect an improvement of 28
days in progression-free survival. Secondary endpoints include
response rate, duration of response, overall survival and incidence
and severity of adverse events. The study is currently planned to
begin dosing patients in Q1 2006. M. Wasif Saif, MD, MBBS,
Associate Professor of Yale University School of Medicine is the
national principal investigator. CoFactor Proposed Phase III Breast
Cancer Clinical Trial Design: The proposed Phase III clinical trial
would be a randomized parallel group trial in patients with
advanced breast cancer who have completed taxane and doxorubicin
treatment. Patients would be equally randomized to two arms
containing either CoFactor in combination with 5-FU or capecitabine
(Xeloda(R)). Primary endpoints would be progression-free survival
and overall survival. Secondary endpoints would be response rate
and severity of adverse events. The Company currently plans to
enroll a total of 450 patients in this proposed Phase III clinical
trial pending clearance regarding the clinical design from the US
Food and Drug Administration (FDA). "CoFactor appears to offer a
less toxic alternative to leucovorin with improved pharmacodynamics
and anti-tumor activity in combination with 5-FU. The planned
studies are designed to definitively establish these attributes in
multiple clinical settings," noted James A. Merritt, MD, chief
medical advisor for ADVENTRX. 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 agent 5-fluorouracil (5-FU). CoFactor creates more
stable binding of the active form of 5-FU to the target enzyme,
thymidylate synthase (TS), improving 5-FU performance. The Company
reported Phase II results from an independent radiological
assessment that found an overall clinical benefit of 85% and
objective response of 35% in metastatic colorectal cancer patients
treated with CoFactor and 5-FU. 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.
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, Inc., +1-858-552-0866 Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
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