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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) March
7, 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 March
7, 2005, the Company announced certain developments regarding its CoFactor Phase
II and IIb trials, and current plans regarding certain regulatory
filings.
The press
release issued by the Company on March 7, 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 | ||
March 7, 2005 |
EXHIBIT
INDEX
Exhibit |
Description |
99.1
|
Press
Release of the Company dated March 7, 2005.
|
Exhibit
99.1
ADVENTRX
ANNOUNCES PRIMARY ENDPOINT
MET
IN COFACTOR PHASE II METASTATIC COLORECTAL CANCER TRIAL
SAN
DIEGO - March 7, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that the primary
endpoint for response rate was met in the study, “COFU: a multi-center Phase II
clinical trial to evaluate the safety and efficacy of weekly treatment with
CoFactor’ and
5-fluorouracil in patients with metastatic colorectal carcinoma.” Further
clinical data will be collected as the remaining patients continue to undergo
evaluation. The Company also announced that some of these data were submitted in
an abstract to 2005 American Society of Clinical Oncology (ASCO) Annual Meeting
being held from May 13-17, 2005 in Orlando.
CoFactor
is a biomodulator developed to enhance the activity of the widely used cancer
drug 5-fluorouracil (5-FU). This open-label, single arm, Simon two-stage
design Phase II CoFactor clinical trial includes patients with surgically
incurable, metastatic colon or rectal adenocarcinoma. Response rate is
defined in this Phase II trial as the tumor shrinking at least 50%, based on
World Health Organization criteria, or complete response following treatment as
measured by CT or MRI scans. Other endpoints being evaluated are safety,
time-to-tumor-progression and overall survival.
“We are
exceptionally pleased to see continued positive results in patients treated with
CoFactor in combination with 5-FU in this Phase II trial as we prepare to
initiate three additional clinical trials with CoFactor this year," said Evan M.
Levine, ADVENTRX president and chief executive officer.
ADVENTRX
has filed Clinical Trial Applications in the European Union (EU), including the
United Kingdom and Germany, and in countries outside the EU for clearance to
evaluate CoFactor in a Phase IIb, international, multi-center, randomized,
controlled trial for metastatic colorectal cancer. Additionally, the Company
currently plans to file in the first half of 2005 for clearance with the U.S.
Food and Drug Administration to launch a Phase III randomized controlled trial
in metastatic colorectal cancer. The Company also currently plans to submit a
Clinical Trial Application in Europe in the first half of 2005 to conduct a
Phase IIb study in patients with advanced pancreatic cancer.
About
ADVENTRX
ADVENTRX
Pharmaceuticals, Inc. is a biopharmaceutical research and development company
with a business strategy to commercialize leading edge medical research through
licensing agreements with prominent universities and research
institutions. The Company focuses on cancer and viral research to launch
products that either extend the usefulness of current therapies or replace
marginal therapies with new approaches to treatment. 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.