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.
SOURCE Allos Therapeutics, Inc.
 back to top
Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman, Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227,
jneiman@allos.com
|
