![](https://savarapharma.com/wp-content/uploads/page-header-blue-ridges-m.jpg)
![](https://savarapharma.com/wp-content/uploads/page-header-blue-ridges-d.jpg)
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) May
2, 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 May 2,
2005, the Company announced that it would be announcing preliminary results for
its CoFactor Phase II Trial, which will be published at the ASCO Annual Meeting,
held May 13-17, in Orlando, Fla.
The press
release issued by the Company on May 2, 2005 with respect to this matter is
included with this report as an exhibit.
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 | ||
May 2, 2005 |
EXHIBIT
INDEX
Exhibit
|
Description
|
99.1
|
Press
Release of the Company dated May 2, 2005.
|
Exhibit
99.1
ADVENTRX’s
Preliminary Results for CoFactor Phase II Trial Published at
ASCO
SAN
DIEGO - May 2, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that an abstract with
preliminary safety and efficacy results from its Phase II trial using
CoFactor’ with
5-fluorouracil (5-FU) for the treatment of metastatic colorectal cancer will be
published in the American Society of Clinical Oncology (ASCO) 2005 Annual
Meeting Proceedings. CoFactor is ADVENTRX’s biomodulator designed to enhance the
activity of the widely used cancer drug 5-fluorouracil (5-FU).
The ASCO
Annual Meeting will be held May 13-17, in Orlando, Fla. The Company currently
plans to announce an update of the Phase II results reported in abstract #3698
entitled, “A Simon 2 stage study of 5, 10 methylenetetrahydrofolic acid (CO)
with 5-fluorouracil (FU) as first line treatment in metastatic colorectal cancer
(mCRC),” following the commencement of the ASCO Annual Meeting.
“We are
encouraged by our continued progress with CoFactor as we have, in a relatively
short time, completed patient enrollment in our Phase II trial, met our primary
clinical endpoint, and based on these results, received approval to initiate two
late stage trials,” said Evan M. Levine, president and CEO for ADVENTRX. “We
look forward to announcing additional Phase II results, which we believe will
further support our efforts to bring CoFactor through the regulatory
process.”
ADVENTRX
recently received clearance to begin a US Phase III pivotal trial and clearance
in the UK to begin an international Phase IIb trial using CoFactor with 5-FU in
metastatic colorectal cancer and plans to initiate both trials this year. The
Company currently plans to file in the first half of this year for clearance to
initiate an EU-based Phase III CoFactor study in pancreatic cancer.
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:
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 | |
Media
Contact:
Lippert/Heilshorn
& Associates
Mark
Stuart (mstuart@lhai.com)
310-691-7116 |