Results Reported at the American Society of Hematology Annual Meeting Affirm Impressive Activity of Allos Therapeutics' Novel An
12 December 2006 - 3:46AM
PR Newswire (US)
WESTMINSTER, Colo., Dec. 11 /PRNewswire-FirstCall/ -- Allos
Therapeutics, Inc. (NASDAQ:ALTH) today announced the presentation
of interim results from its on-going Phase 1/2 trial of PDX
(pralatrexate) in patients with relapsed or refractory
non-Hodgkin's Lymphoma and Hodgkin's Disease. Owen A. O'Connor,
M.D., Ph.D., Head of the Laboratory of Experimental Therapeutics
for Lymphoproliferative Malignancies, Lymphoma and Development
Chemotherapy Services, Memorial Sloan-Kettering Cancer Center
(MSKCC), and the study's principal investigator, presented the
findings in an oral presentation today at the 48th Annual Meeting
of the American Society of Hematology in Orlando, FL. "Pralatrexate
continues to demonstrate a remarkably high response rate and
duration of response in heavily pre-treated peripheral T-cell
lymphoma patients," said Dr. O'Connor. "Results of the expanded
Phase 1/2 experience suggest that pralatrexate has the potential to
alter the clinical course of disease in a wide variety of patients
with refractory T-cell lymphoma." In an oral presentation titled
"Pralatrexate (PDX) Produces Durable Complete Remissions in
Patients with Chemotherapy Resistant Precursor and Peripheral
T-Cell Lymphomas: Results of the MSKCC Phase I/II Experience," Dr.
O'Connor presented interim data from the ongoing Phase 1/2 trial,
designed to determine the maximum tolerated dose (MTD), dose
limiting toxicities (DLT) and efficacy of PDX in patients with
relapsed or refractory aggressive lymphomas. Results of the
analysis demonstrated a high overall response rate in patients with
various subtypes of T-cell lymphoma. Notably, responses were
observed in 10 of 22 (45%) evaluable patients with T-cell lymphoma,
including nine complete responses. Six of the patients remain in
remission three to 21 months later. "These results continue to
validate our belief in PDX's potential as a promising new
therapeutic option for patients with peripheral T-cell lymphoma,
and heighten our excitement around the on-going pivotal Phase 2
PROPEL trial," said Paul L. Berns, Allos' President and Chief
Executive Officer. "We look forward to reporting results from an
interim assessment of safety data from the PROPEL trial in the
first quarter of 2007." In total, 54 patients have been treated
with PDX in this study. The overall response rate for the evaluable
population was 28%. Twenty-four of 54 (44%) patients had B-cell
lymphoma, of which 10% achieved a partial response with PDX. The
addition of vitamins to the treatment regimen appeared to mitigate
the occurrence of stomatitis, the toxicity commonly associated with
PDX. DLTs observed to date have been primarily hematologic. "We
believe the clinical signal we've observed in patients with B-cell
lymphoma in this study, coupled with compelling pre-clinical
results, provides strong justification for further evaluation of
PDX in this setting," said Michael E. Saunders, Allos' Vice
President, Clinical Development. "Moving forward we plan to explore
alternate doses, schedules and combinations, which we believe may
allow us to broaden the population of patients that benefit from
PDX." PDX is currently the subject of a pivotal Phase 2,
international, multi- center, open-label, single-arm study called
PROPEL that will seek to enroll 100 evaluable patients with
relapsed or refractory PTCL who have progressed after at least one
prior treatment. The primary endpoint of the study is objective
response rate (complete and partial response). Secondary endpoints
include duration of response, progression-free survival and overall
survival. Dr. O'Connor is the international chair of this study. In
August 2006, the Company announced that it reached agreement with
the FDA under the Special Protocol Assessment process on the design
of this pivotal Phase 2 trial. The Company currently anticipates
that patient enrollment at up to 35 centers in the U.S., Canada and
Europe will be completed by the third quarter of 2008. In July
2006, the FDA awarded orphan drug designation to PDX for the
treatment of patients with T-cell lymphoma. About the Phase 1/2
Study In the Phase 1 portion of this study, patients with
aggressive non- Hodgkin's lymphoma (diffuse large B- or T-cell
lymphoma, mantle cell lymphoma, transformed large cell lymphomas)
or Hodgkin's Disease were administered increasing doses of PDX with
vitamin B12 and folic acid supplementation as part of either a
three or six week schedule. Accrual is currently on-going in the
Phase 2 portion of the study with the recommended dose of 30 mg/m2
of PDX once every week for six weeks followed by one week of rest
per cycle of treatment. Patient response is assessed using the
Cheson criteria, which includes both CT and PET. Analyst/Investor
Event The Company will host an event in Orlando on Monday, December
11, 2006, at the Rosen Centre Hotel from 1:00 PM - 2:30 PM to
discuss the emerging role of PDX in the treatment of patients with
peripheral T-cell lymphoma. This event will be accessible by
conference call and webcast. Conference Call/Webcast The dial in
number for U.S. residents to participate is 877-407-8031.
International callers should dial 201-689-8031. Participants should
reference the Allos Therapeutics conference call. The webcast will
be available from the homepage and the investors/media section of
the Company's web site at http://www.allos.com/ and will be
archived for 10 days. Slides will be available to call participants
via the webcast. About PDX (pralatrexate) PDX is a novel, small
molecule chemotherapeutic agent that inhibits dihdrofolate
reductase (DHFR), a folic acid (folate) dependent enzyme involved
in the building of DNA and other processes. PDX was rationally
designed for improved transport into tumor cells via the reduced
folate carrier (RFC-1), and greater intracellular drug retention.
These biochemical features, together with preclinical data in a
variety of tumors, suggest that PDX has an enhanced potency and
improved toxicity profile relative to methotrexate and other
related DHFR inhibitors. About Peripheral T-cell Lymphoma
Peripheral T-cell lymphomas, or PTCLs, are a biologically diverse
and uncommon group of blood cancers that account for approximately
10% to 15% of all cases of non-Hodgkin's lymphoma, or about 6,700
patients annually. The average 5-year survival rate for PTCL
patients is approximately 25%. There are currently no
pharmaceutical agents approved for use in the treatment of either
first-line or relapsed or refractory PTCL. About Allos
Therapeutics, Inc. Allos Therapeutics, Inc. (ALTH) is a
biopharmaceutical company focused on the development and
commercialization of small molecule therapeutics for the treatment
of cancer. The Company has two product candidates in late-stage
clinical development: EFAPROXYN (efaproxiral), a radiation
sensitizer currently under evaluation in a pivotal Phase 3 trial in
women with brain metastases originating from breast cancer, and PDX
(pralatrexate), a novel, next generation antifolate currently under
evaluation in a pivotal Phase 2 trial in patients with relapsed or
refractory peripheral T-cell lymphoma. The Company is also
evaluating RH1, a targeted chemotherapeutic agent, in a Phase 1
trial in patients with advanced solid tumors. For additional
information, please visit the Company's website 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
relating to the potential safety and efficacy of PDX for the
treatment of T- cell and B-cell lymphoma; the Company's projected
timelines for completing enrollment in the PROPEL trial; the
Company's intent to explore alternate treatment regimens for PDX
for the treatment of B-cell lymphoma 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 the Company may
experience delays in the completion of the PROPEL trial, whether
caused by competition, adverse events, patient enrollment rates,
regulatory issues or other factors; that clinical trials may not
demonstrate that PDX is both safe and effective for the treatment
of patients with T-cell lymphoma or any other type of cancer; that
data from preclinical studies and clinical trials may not be
indicative of future clinical trial results; that the safety and/or
efficacy results of clinical trials for PDX may not support an
application for marketing approval in the United States or any
other country; that an application for marketing approval may not
be accepted for priority review or at all by the FDA or any other
regulatory authority; and that the Company may lack the financial
resources and access to capital to fund future clinical trials for
PDX 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, 2005 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 for Allos Therapeutics,
+1-720-540-5227, On-Site: +1-303-518-4114, Web site:
http://www.allos.com/
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