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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
25, 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
25, 2005, the Company announced that it received FDA clearance for its CoFactor
Phase III pivotal trial in metastatic colorectal cancer.
The press
release issued by the Company on April 25, 2005 with respect to this matter is
included with this report as anexhibit.
Item
9.01. Financial Statements and Exhibits.
(99) |
©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
25, 2005 |
EXHIBIT
INDEX
Exhibit
|
Description
|
99.1
|
Press
Release of the Company dated April 25, 2005.
|
Exhibit
99.1
ADVENTRX
RECEIVES FDA CLEARANCE FOR COFACTOR PHASE III
PIVOTAL
TRIAL IN METASTATIC COLORECTAL CANCER
SAN
DIEGO - April 25, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that it has received
clearance from the US Food and Drug Administration (FDA) under a Special
Protocol Assessment (SPA) to initiate a Phase III pivotal clinical trial with
CoFactor for the treatment of metastatic colorectal cancer. CoFactor is the
Company’s biomodulator designed to enhance the activity of the widely used
cancer drug 5-fluorouracil (5-FU).
The US
Phase III pivotal clinical trial will be a randomized, open label multi-center,
parallel group, study of CoFactor as a first-line, combination therapy in
patients with metastatic colorectal carcinoma. The two-arm study is expected to
include approximately 600 patients, half of whom will be treated with CoFactor,
5-FU and bevacizumab (Avastin’),
compared with the other half of the patient population who will be treated with
leucovorin, 5-FU and bevacizumab (Avastin’). The
primary end-point for this study is progression free survival (PFS), defined as
the time from start of treatment to time of disease progression or death.
ADVENTRX
recently received clearance in the UK to begin an international Phase IIb trial
with CoFactor in metastatic colorectal cancer and plans to file in the first
half of this year for clearance to initiate a EU-based Phase III CoFactor study
in pancreatic cancer. Results from the Company’s ongoing Phase II clinical trial
using CoFactor and 5-FU for metastatic colorectal cancer are expected to be
announced in Q2 2005.
About
CoFactor
CoFactor
is a folate-based biomodulator drug developed to enhance the activity of the
widely used cancer chemotherapeutic, 5-FU. Clinical 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. In comparison to leucovorin, CoFactor creates more stable binding of the
active form of 5-FU, FdUMP, 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. ADVENTRX is the exclusive licensee of this
compound. 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 annual report on Form
10-KSB, 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: | Investor Contact: | |
ADVENTRX Pharmaceuticals | Lippert, Heilshorn & Associates | |
Andrea Lynn | Jody Cain (jcain@lhai.com) | |
858-552-0866 | Brandi Floberg (bfloberg@lhai.com) | |
310-691-7100 |
Media Contact | ||
Lippert Heilshorn & Associates | ||
Mark Stuart (mstuart@lhai.com) | ||
310-691-7116 | ||