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
29, 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
29, 2005, the Company announced certain developments regarding its planned
CoFactor Phase III trial for pancreatic cancer in the European Union.
The press
release issued by the Company on March 29, 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. | ||
|
|
|
Date: March 29, 2005 | By: | /s/ Carrie E. Carlander |
Name:
Carrie E. Carlander | ||
Title: Chief Financial Officer, Vice President, Finance, and Treasurer |
EXHIBIT
INDEX
Exhibit |
Description |
99.1
|
Press
Release of the Company dated March 29, 2005.
|
Exhibit
99.1
ADVENTRX
RECEIVES COFACTOR PANCREATIC CANCER CLINICAL
DESIGN
AND PROTOCOL FINAL ADVICE LETTER FROM EMEA
SAN
DIEGO - March 29, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced receipt of a final
advice letter from the European Medicines Agency (EMEA) for its proposed
CoFactor™ trial protocol in pancreatic cancer. Based on this information, the
Company currently plans to file a Clinical Trial Application for a pivotal Phase
III multinational study in patients with advanced pancreatic cancer in the
second quarter of 2005 and will initiate the trial following regulatory
clearance. CoFactor is a biomodulator designed to enhance the activity of the
widely used cancer drug 5-fluorouracil (5-FU).
The final
advice letter was received following a recent meeting between ADVENTRX and the
EMEA in which the Company sought assistance on the trial design protocol.
Protocol assistance with the EMEA was provided without additional cost to the
Company under the Orphan drug act. CoFactor was granted orphan drug status for
pancreatic cancer in both the European Union (EU) and US in October of last
year.
The
primary endpoint of the proposed pivotal Phase III clinical trial is time to
tumor progression with secondary endpoints of objective response, quality of
life and overall survival. Approximately 480 patients will be randomized to
receive either CoFactor/5-FU/gemcitabine or gemcitabine alone. Gemcitabine is
the current standard of care in the EU and US for advanced pancreatic cancer.
The international trial is expected to be conducted at both EU and non-EU
clinical sites.
In a
previous Phase I/II clinical trial in Europe, CoFactor in combination with 5-FU
demonstrated clinical benefit, defined as stable disease or tumor response, in
40% of pancreatic patients.
“Our
progress with the EMEA marks an important milestone in our efforts to advance
CoFactor through the clinical process,” said Cellia Habita, M.D., Ph.D., senior
vice president of clinical and medical affairs for ADVENTRX. “Our earlier
clinical studies with CoFactor in combination with 5-FU as a cancer therapy
indicates its potential to lower toxicities and increase survival compared with
current therapies. Pancreatic cancer is among the most fatal cancers with less
than 5 percent of patients surviving more than five-years following diagnosis."
CoFactor
in combination with 5-FU is currently being studied in a Phase II trial in
metastatic colorectal cancer in the US and Europe. During the first quarter of
2005, ADVENTRX filed for clearance with the US Food and Drug Administration to
launch a Phase III randomized, controlled trial in metastatic colorectal cancer.
Also during the first quarter of 2005, the Company filed Clinical Trial
Applications in the 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.
About
ADVENTRX
ADVENTRX
Pharmaceuticals, Inc. 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