SAN DIEGO, Sept. 18 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals,
Inc. (Amex: ANX) today announced data demonstrating that, in mice with
metastatic colorectal cancer, treatment with CoFactor(R) in combination with
Uftoral(R) (UFT) resulted in greater inhibition of tumor growth and longer
median survival time than treatment with UFT-plus-leucovorin or UFT alone.
The data were presented in Beijing at a joint meeting of the 7th International
Conference of Asian Clinical Oncology Society (ACOS) & the 9th Annual Meeting
of Chinese Society of Clinical Oncology (CSCO) on Saturday, September 16,
2006. CoFactor is a folate-based drug designed to improve the efficacy and
safety of the anticancer agent 5-fluorouracil (5-FU). UFT, an oral anticancer
drug approved for use in Asia and Europe, delivers a combination of tegafur, a
prodrug of 5-FU, and uracil.
In a xenograft model for a human colorectal tumor (HT-29) treatment with
CoFactor-plus-UFT resulted in the greatest inhibition of tumor growth among
the three treatment groups, as well as the control group. CoFactor-plus-UFT
tumor volume of 272 +/- 24mm3, mean tumor size +/- SEM, was statistically
significantly less than tumor volume of 376 +/- 32mm3 in the control group.
In contrast, only minor tumor reduction was observed in the
UFT-plus-leucovorin group (361 +/- 36mm3) and the UFT-alone group
(364 +/- 26mm3). This enhanced anti-tumor activity of CoFactor-plus-UFT was
associated with statistically significant longer median survival time
(60 days) than the control group (45 days). Median survival time of the
UFT-plus-leucovorin group (54 days) and UFT alone group (54 days) compared
with that with the control group was not statistically significant. In
addition, treatment with CoFactor-plus-UFT was well tolerated. Animals were
treated with identical doses of CoFactor or leucovorin (0.6 mg/day) prior to
UFT dosing (20 mg/kg/day) for 14 consecutive days.
"These CoFactor/UFT results are further evidence of CoFactor's improved
ability over leucovorin to potentiate the efficacy of fluoropyrimidines," said
Evan M. Levine, the Company's chief executive officer. "Results from numerous
preclinical studies with and without the addition of oxaliplatin, anti-VEGF or
gemcitabine suggest that CoFactor is more effective than leucovorin at
modulating 5-FU, thereby increasing inhibition of tumor growth in colorectal,
gastric and pancreatic tumor models while demonstrating reduced toxicity."
The abstract entitled "5,10-Methylenetetrahydrofolate (CoFactor) Enhances
UFT Antitumor Activity Against Human Colorectal HT-29 Tumor Xenografts in Nude
Mice" was presented by Mark J. Cantwell, Ph.D., vice president of research and
development for ADVENTRX. The poster presentation will be available for
download on the Company's Web site at
http://www.adventrx.com/library/publications.htm.
About CoFactor
CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance
the activity and reduce associated toxicity of the widely used cancer
chemotherapeutic agent 5-fluorouracil (5-FU). CoFactor creates more stable
binding of the active form of 5-FU to the target enzyme, thymidylate synthase
(TS), improving 5-FU performance. The Company reported Phase II clinical
trial results from an independent radiological assessment that found an
objective response rate of 35% in first-line treatment of metastatic
colorectal cancer with CoFactor and 5-FU. The Company also reported median
time to tumor progression (TTP) of 162 days, preliminary median overall
survival of 459 days with no study drug-related grade 3 or grade 4
gastrointestinal or hematological toxicity. CoFactor is being tested in
first-line treatment of metastatic colorectal cancer in a Phase IIb clinical
trial in Europe and India and a Phase III pivotal clinical trial in the U.S.
About ADVENTRX
ADVENTRX Pharmaceuticals is a biopharmaceutical research and development
company focused on introducing treatments for cancer and infectious disease
that surpass the performance and safety of existing drugs, by addressing
significant problems such as drug metabolism, toxicity, bioavailability and
resistance. More information can be found on the Company's Web site at
www.adventrx.com.
Forward Looking Statement
ADVENTRX cautions you that statements included in this press release that
are not a description of historical facts are forward-looking statements that
involve risks, uncertainties, assumptions and other factors that, if they do
not materialize or prove to be accurate, could cause ADVENTRX's results to
differ materially from historical results or those expressed or implied by
such forward-looking statements. Such forward-looking statements are made
based on management's current expectations and beliefs and should not be
regarded as a statement or representation by ADVENTRX that any of its plans
will be achieved. The potential risks and uncertainties that could cause
actual results to differ materially include, but are not limited to: the risk
that preclinical results are not indicative of the success of subsequent
clinical trials; the validity of research results; the risk that products will
not perform as preclinical data suggests or as otherwise anticipated; the risk
that competitors develop superior products; the potential for regulatory
authorities to require additional preclinical work or other clinical
requirements to support regulatory filings; unexpected side effects or
inadequate therapeutic efficacy of CoFactor; the uncertain process of seeking
regulatory approval for ADVENTRX's products; and other risks and uncertainties
more fully described in ADVENTRX's press releases and periodic filings with
the Securities and Exchange Commission. ADVENTRX's public filings with the
Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date when made. All forward-looking
statements are qualified in their entirety by this cautionary statement and
ADVENTRX assumes no obligation to revise or update any forward-looking
statement, including as set forth in this press release, to reflect events or
circumstances arising after the date on which it was made.
SOURCE ADVENTRX Pharmaceuticals, Inc.
09/18/2006
CONTACT: Andrea Lynn of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866