Interim Phase 1 Data on RH1 Presented at AACR-NCI-EORTC Conference
17 11월 2005 - 10:01PM
PR Newswire (US)
WESTMINSTER, Colo., Nov. 17 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the presentation
of interim data from an on-going, multi-center, Phase 1 dose
escalation study of the Company's anti-cancer agent RH1. Dr.
Malcolm Ranson, M.D. of Christie Hospital and the Paterson
Institute for Cancer Research, Manchester, UK, presented the
findings in a poster presentation today at the 17th Annual
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics in Philadelphia, PA. In abstract #C205, titled
"Phase 1 Pharmacokinetic (PK) and Pharmacodynamic (PD) data of the
Bioreductive drug RH1," Dr. Ranson and colleagues presented an
update of the on-going Phase 1 trial designed to determine the
toxicity profile, maximum tolerated dose (MTD) and dose limiting
toxicity of RH1 in adult patients with advanced solid tumors. At
this interim analysis, 15 patients have received RH1 daily for five
days every three weeks at doses ranging from 40 microg/m2 to 1905
microg/m2 for up to six cycles. RH1 was well tolerated at doses up
to 1430 microg/m2. Clinically significant toxicities observed to
date include neutropenia, thrombocytopenia and mild to moderate
phlebitis. No objective tumor responses have been observed thus
far. However, significant, accumulative dose-dependent DNA
cross-linking has been seen in peripheral blood lymphocytes at all
doses greater than or equal to 200 microg/m2. DNA cross linking
studies are presently being extended to tumor samples. An expanded
cohort is on-going at 1430 microg/m2 to confirm this dose as the
MTD. Study Design In this Phase 1 study, patients with advanced
solid tumors refractory to other chemotherapy regimens are
administered increasing doses of RH1. RH1 is administered as a 10 -
30 minute intravenous infusion (IV) on day 1 - 5 every three weeks
for up to six cycles. Toxicity is assessed using the National
Cancer Institute Common Toxicity Criteria (NCI-CTC). About RH1 RH1
is a small molecule chemotherapeutic agent that is bioactivated by
the enzyme DT-diaphorase, or DTD, which is over-expressed in many
tumors relative to normal tissue, including lung, colon, breast and
liver tumors. The bioactivated form is a potent cytotoxic agent
that induces DNA inter-strand cross-linking. Because RH1 is
bioactivated in the presence of DTD, it has the potential to
provide targeted drug delivery to these tumor types while limiting
the toxicity to normal tissue. RH1 has undergone in vivo testing by
the Departmental Therapeutics Program of the National Cancer
Institute and has demonstrated significant activity in both NSCLC
and ovarian xenograft models. About Allos Therapeutics, Inc. Allos
Therapeutics, Inc. (NASDAQ:ALTH) is a biopharmaceutical company
focused on developing and commercializing innovative small molecule
therapeutics for the treatment of cancer. The Company's lead
product candidate, EFAPROXYN(TM) (efaproxiral), is a synthetic
small molecule designed to sensitize hypoxic, or oxygen-deprived,
tumor tissue during radiation therapy. EFAPROXYN is currently being
evaluated as an adjunct to whole brain radiation therapy in a
pivotal Phase 3 trial in women with brain metastases originating
from breast cancer. The Company's other product candidates are: PDX
(pralatrexate), a small molecule chemotherapeutic agent (DHFR
inhibitor) currently under investigation as both a single agent and
in combination therapy regimens in patients with non-small cell
lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule
chemotherapeutic agent bioactivated by the enzyme DT-diaphorase
currently under evaluation in patients with advanced solid tumors.
For more information, please visit the Company's web site at:
http://www.allos.com/. Safe Harbor Statement This press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements include statements
concerning the potential for RH1 to provide targeted drug delivery
to selected tumor types while limiting the toxicity to normal
tissue; and other statements that are other than statements of
historical facts. In some cases, you can identify forward-looking
statements by terminology such as "may," "will," "should,"
"expects," "intends," "plans," anticipates," "believes,"
"estimates," "predicts," "projects," "potential," "continue," and
other similar terminology or the negative of these terms, but their
absence does not mean that a particular statement is not
forward-looking. Such forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties
that may cause actual results to differ materially from those
anticipated by the forward-looking statements. These risks and
uncertainties include, among others: that clinical trials may not
demonstrate that RH1 is both safe and more effective than current
standards of care; that data from preclinical studies and clinical
trials may not necessarily be indicative of future clinical trial
results; that the safety and/or efficacy results of clinical trials
for RH1 will not support an application for marketing approval in
the United States or any other country; and the risk that the
Company may lack the financial resources and access to capital to
fund future clinical trials for RH1 or any of its other product
candidates. Additional information concerning these and other
factors that may cause actual results to differ materially from
those anticipated in the forward- looking statements is contained
in the "Risk Factors" section of the Company's Annual Report on
Form 10-K for the year ended December 31, 2004, and in the
Company's other periodic reports and filings with the Securities
and Exchange Commission. The Company cautions investors not to
place undue reliance on the forward-looking statements contained in
this press release. All forward- looking statements are based on
information currently available to the Company on the date hereof,
and the Company undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this presentation, except as required by law. Note:
EFAPROXYN(TM) and the Allos logo are trademarks of Allos
Therapeutics, Inc. DATASOURCE: Allos Therapeutics, Inc. CONTACT:
Jennifer Neiman, Manager, Corporate Communications of Allos
Therapeutics, +1-720-540-5227, Web site: http://www.allos.com/
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Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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