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Filing
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15 (d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
Report (Date of earliest event reported) April
15, 2005
ADVENTRX
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
(State or
other jurisdiction of incorporation)
001-32157
(Commission
File Number) |
84-1318182
(IRS
Employer Identification No.) |
6725
Mesa Ridge Road, Suite 100
San
Diego, California 92121
(Address
of principal executive offices) (Zip Code)
(858)
552-0866
(Company’s
telephone number, including area code)
Item
8.01. Other Events.
On April
15, 2005, the Company announced that it was granted clearance
in the UK for a CoFactor Phase IIb
metastatic
colorectal cancer trial.
The press
release issued by the Company on April 15, 2005 with respect to these matters is
included with this report as an exhibit.
Item
9.01. Financial Statements and Exhibits.
(c) The
exhibit list required by this item is incorporated by reference to the Exhibit
Index filed as part of this report.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
ADVENTRX Pharmaceuticals, Inc. | ||
|
|
|
By: | /s/ Carrie E. Carlander | |
Name:
Carrie E. Carlander | ||
Title:
Chief Financial Officer, Vice
President, Finance, and Treasurer April
15, 2005 |
EXHIBIT
INDEX
Exhibit
|
Description
|
99.1
|
Press
Release of the Company dated April 15, 2005.
|
Exhibit
99.1
ADVENTRX
GRANTED CLEARANCE IN THE UK FOR COFACTOR PHASE IIB
METASTATIC
COLORECTAL CANCER TRIAL
SAN
DIEGO - April 15, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that it has received
clearance from the Medicines and Healthcare products Regulatory Agency (MHRA) to
begin an international Phase IIb randomized controlled clinical trial using
CoFactor™ with 5-fluorouracil (5-FU) in metastatic colorectal cancer in the
United Kingdom. The Company expects to begin patient enrollment for this trial
by the end of April 2005. The trial will be conducted at clinical sites in the
European Union (EU) and countries outside of the EU following regulatory and
ethics approval in each country.
“This
clearance comes on the heels of meeting our primary clinical endpoint for
response rate with our ongoing US CoFactor Phase II trial in metastatic
colorectal cancer,” said Evan M. Levine, president and CEO of ADVENTRX. “This is
an important step in the overall late stage clinical development of CoFactor and
we look forward to launching this Phase IIb trial in the UK and other countries
involved. We also look forward to launching two Phase III pivotal trials for
CoFactor; one for metastatic colorectal cancer in the US; and one for pancreatic
cancer in Europe.”
This
Phase IIb study is an international, multi-center, open label, randomized,
controlled clinical trial to evaluate the safety and efficacy of treatment with
CoFactor plus 5-FU in patients with metastatic colorectal carcinoma. ADVENTRX
plans to conduct this trial in the UK, Germany, Romania, Poland, Serbia, India
and Croatia. Approximately 300 patients will be randomized to receive either
CoFactor plus 5-FU or leucovorin plus 5-FU. The primary endpoint for this trial
is defined as reduction of grade 3 or greater toxicity as defined by the NCI
Common Terminology Criteria for Adverse Events (version 3) in the CoFactor/5-FU
arm over the leucovorin/5-FU arm. Secondary endpoints are response rate, time to
progression, and quality of life. The global prinicipal investigator for the
trial is Professor James Cassidy, M.D., MBChB, MSc, FRCP.
Dr. James
Cassidy is Professor of Oncology and Head of the Department of Cancer Research
in the UK Department of Medical Oncology at the University of Glasgow in
Glasgow, Scotland. Professor Cassidy has published over 140 peer-reviewed
articles in scientific and medical journals and has led high profile oncology
clinical studies, including most recently the X-ACT study.
“We are
pleased that an investigator of Dr. Cassidy’s caliber has agreed to lead this
clinical trial as he brings significant experience in conducting novel drug
development in colorectal cancer therapeutics,” said Cellia Habita, M.D., Ph.D.,
senior vice president of medical and clinical affairs of ADVENTRX.
ADVENTRX
has filed for clearance to initiate a Phase III trial in the US with CoFactor in
metastatic colorectal cancer and currently plans to file in the first half of
this year for clearance to initiate an EU-based Phase III study in pancreatic
cancer.
About
CoFactor
CoFactor
is a folate-based biomodulator developed to enhance the activity of the widely
used cancer chemotherapeutic, 5-FU. Data from previous clinical trials in Europe
have demonstrated clinical benefit and improved overall median survival in
patients with advanced tumors, including colorectal, pancreatic and breast.
CoFactor creates more stable binding, compared to leucovorin, of the active form
of 5-FU, FdUMP, to the target enzyme, thymidylate synthase. CoFactor bypasses
the chemical pathway required by leucovorin to deliver the active form of folate
which allows 5-FU to work more effectively. This improves 5-FU performance and
lowers toxicity. More information on CoFactor can be found at http://www.adventrx.com/products/antic_cofactor.htm.
About
ADVENTRX
ADVENTRX
Pharmaceuticals is a biopharmaceutical research and development company focused
on introducing new technologies for anticancer and antiviral treatments that
improve the performance of existing drugs and address significant problems such
as drug metabolism, bioavailability and resistance. More information can be
found on the Company's Web site at 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. 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, see “Risk Factors” in the Company’s last quarterly report on Form
10-QSB, as well as other reports that the Company files from time to time with
the Securities and Exchange Commission. All forward-looking statements are
qualified in their entirety by this cautionary statement. The Company undertakes
no obligation to release publicly any revisions, which may be made to reflect
events or circumstances after the date hereof.
Contact:
ADVENTRX
Pharmaceuticals
Andrea
Lynn
858-552-0866
Investor
Contact:
Lippert
Heilshorn & Associates
Jody Cain
(jcain@lhai.com)
Brandi
Floberg (bfloberg@lhai.com)
310-691-7100