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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
11, 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
11, 2005, the Company announced that CoFactor Phase II and preclinical toxicity
data will be presented at the American Association for Cancer Research Annual
Meeting, April 16-20 in Anaheim, CA.
The press
release issued by the Company on April 11, 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
11, 2005 |
EXHIBIT
INDEX
Exhibit
|
Description
|
99.1
|
Press
Release of the Company dated April 11, 2005.
|
Exhibit
99.1
ADVENTRX’S
COFACTOR PHASE II AND PRECLINICAL TOXICITY DATA TO BE PRESENTED AT AACR ANNUAL
MEETING
SAN
DIEGO - April 11, 2005 -
ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) today announced that two abstracts
featuring CoFactor™ toxicity and pharmacodynamics data will be presented at the
American Association for Cancer Research (AACR) Annual Meeting, April 16-20 in
Anaheim, Calif. These data were collected from the Company’s ongoing CoFactor
Phase II clinical trial in metastatic colorectal cancer and a recent preclinical
study that compared toxicity and anti-tumor activity of CoFactor used in
combination with 5-fluorouracil (5-FU) and a variety of other therapeutic
agents, including an antibody directed against vascular endothelial growth
factor (anti-VEGF). CoFactor is a biomodulator designed to enhance the activity
of the widely used cancer drug 5-FU.
“We are
pleased to be reporting toxicity data less than one year after dosing the first
patient in our current Phase II study of CoFactor, and we intend to announce
preliminary efficacy data from this trial in May,” said
Evan M. Levine, ADVENTRX president and CEO. “Further,
we believe these data will support our recent filings with both the US Food and
Drug Administration (FDA) and the European Medicines Agency (EMEA) for clearance
to initiate late stage trials with CoFactor in colorectal cancer. We believe
that we have made substantial progress in the clinical trial process, and we
remain confident in our ability to advance CoFactor through the regulatory
process.”
C. Paul
Spears, M.D., co-inventor of CoFactor, investigator in the COFU trial and lead
author on the clinical abstract, will present a poster entitled
“Pharmacodynamics of weekly intravenous methylenetetrahydrofolate/5-fluorouracil
on formic acid, RBC folate, and homocysteine levels in patients with metastatic
colon cancer” (abstract 3988) on Tuesday, April 19 at 8:00 a.m. PT. This will be
the first presentation of clinical data related to metabolism and toxicity with
CoFactor in metastatic colorectal cancer patients from the Company’s current
Phase II study.
Mark J.
Cantwell, Ph.D., lead author of the recent preclinical study will present a
poster entitled “5,10-methylenetetrahydrofolate/5-fluorouracil combination
therapy shows enhanced antitumor activity and lower systemic toxicity with a
broad range of cytotoxic drugs” (abstract 5107) on Tuesday, April 19, at 1:00
p.m. PT.
These
abstracts will be available via the Company’s Web site at www.adventrx.com
following Dr. Cantwell’s presentation.
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 has demonstrated clinical benefit and improved overall median
survival in patients with advanced tumors, including colorectal, pancreatic and
breast. CoFactor blocks cancer cell growth by creating more stable binding,
compared to leucovorin, of the target enzyme, thymidylate synthase (TS).
CoFactor bypasses the chemical pathway required by leucovorin to deliver the
active form of folate to allow 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 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