WESTMINSTER, Colo., Dec. 12 /PRNewswire-FirstCall/ -- Allos Therapeutics,
Inc. (Nasdaq: ALTH) today announced the presentation of interim results from
an ongoing Phase 1/2 trial of PDX (pralatrexate) in patients with
non-Hodgkin's Lymphoma. Owen O'Connor, M.D., Ph.D., Attending Physician,
Lymphoma Department, Memorial Sloan-Kettering Cancer Center (MSKCC) and the
study's principal investigator, presented the findings in a poster
presentation yesterday at the 47th Annual Meeting of the American Society of
Hematology.
"PDX has achieved a remarkably high complete response rate in a difficult
to treat, drug resistant patient population," said Dr. O'Connor. "Results
seen to date suggest that PDX may offer distinct advantages over current
approaches used in the treatment of T-cell lymphoma."
In abstract #2678, titled "Pralatrexate (10-Propargyl-10-Deazaaminopterin
(PRX(1)), a Novel Antifolate, Effects Durable Complete Remissions (CR) in
Patients with a Diversity of Drug Resistant T-Cell Lymphomas with Minimal
Toxicity," Dr. O'Connor presented interim data from the ongoing Phase
1/2 trial, designed to determine the maximum tolerated dose (MTD), dose
limiting toxicities and preliminary views of efficacy of PDX in patients with
relapsed or refractory aggressive lymphomas. As part of the initial Phase 2
study, 16 patients were treated with PDX according to a dosing schedule of
135 mg/m2 of PDX every other week, with dose escalation (15 mg/m2) for
patients without significant toxicities. The protocol was amended in July
2004 to explore a weekly dosing schedule beginning at 30 mg/m2 for three weeks
in a four week schedule. To date, 11 patients have been accrued to the
amended Phase 1 study at dose levels up to 45 mg/m2, including seven patients
with T-cell lymphoma. In total, eight patients with T-cell lymphoma have been
treated with PDX, of whom five were evaluable for response. Notably, four of
five evaluable patients with T-cell lymphoma achieved a complete remission
within the first cycle, despite being chemotherapy refractory. Three of four
T-cell lymphoma patients remain on treatment and in complete remission four to
nine months later. Moreover, among those patients pre-treated with vitamins,
the previously established dose limiting toxicity of stomatitis was
eliminated. Little hematological toxicity has been observed. MSKCC
investigators are currently enrolling patients in the third dose cohort,
45 mg/m2 of PDX administered weekly for six weeks in a seven week cycle.
"We are encouraged by the activity observed in the on-going Phase 1/2
study and believe it provides strong rationale for continued clinical
development of PDX in T-cell lymphoma," said Michael E. Saunders, M.D., Vice
President, Clinical Development of Allos. "Our intent is to initiate a
multi-center Phase 2 study in this setting in the first half of 2006."
About the Study
In this Phase 1/2 Memorial Sloan Kettering sponsored 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 are
administered increasing doses of PDX with vitamin B12 and folic acid
supplementation. The initial dose level was 30 mg/m2 administered weekly for
three weeks, with one week rest. The dose was increased to 30 mg/m2 weekly
for six weeks in a seven week cycle and currently is being administered at
45 mg/m2 weekly for six weeks in a seven week cycle. There is no limit on the
number of prior therapies.
Conference Call
The Company will host a conference call on Friday, December 16, 2005, at
12 PM ET to review the data presented at the American Society of Hematology
Annual Meeting. The dial in number for U.S. residents to participate is
800-638-5495. International callers should dial 617-614-3946. The pass code to
participate is 57425540.
Webcast
Allos Therapeutics will hold a live webcast of the 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 30 days.
Slides will be available to call participants via the webcast.
About PDX (pralatrexate)
PDX is a small molecule chemotherapeutic agent that inhibits dihdrofolate
reductase, or DHFR, a folic acid (folate) dependent enzyme involved in the
building of DNA and other processes. Preclinical data suggests that PDX has
an enhanced potency and toxicity profile relative to methotrexate and other
related DHFR inhibitors. Drugs that inhibit DHFR, such as methotrexate, were
among the first chemotherapeutic agents discovered. Methotrexate remains one
of the most widely applied antifolate chemotherapeutics and has been used to
treat leukemia, breast, bladder, gastric, esophageal, head and neck cancers.
About Non-Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer and
the fifth leading cause of cancer death in the U.S. An estimated 56,000 new
cases of NHL will be diagnosed each year, of which T-cell lymphoma represents
approximately 12 percent, or 6,700 patients.
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
relating to the interim results of the Phase 1/2 study of PDX in patients with
NHL; the potential safety and efficacy profile of PDX; the Company's plans to
initiate Phase 2 clinical development of PDX for the treatment of patients
with T-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
interim results from the Phase 1/2 study of PDX in patients with NHL may not
be confirmed upon full analysis of the detailed results of the trial; that the
Company may experience delays in the initiation and/or completion of its
clinical trials, 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 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 PDX 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 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, 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: EFAPROXYNTM and the Allos logo are trademarks of Allos Therapeutics,
Inc.
(1) All references to "PRX" in the abstract were the result of a
typographical error, and should have properly referenced "PDX."
SOURCE Allos Therapeutics, Inc.
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Related links:
http://www.allos.com
CONTACT:
Jennifer Neiman Manager, Corporate
Communications of Allos Therapeutics, +1-720-540-5227, or cell,
+1-303-518-4114, jneiman@allos.com
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