Two Pralatrexate Studies Presented at the 50th Annual Meeting of the American Society of Hematology
December 06 2008 - 12:30PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that results
from two pralatrexate (PDX) studies were presented as posters
during the 50th Annual Meeting of the American Society of
Hematology (ASH), on December 6, 2008, in San Francisco,
California. One poster reports interim data from a Phase 1 trial of
pralatrexate as a single agent in patients with relapsed or
refractory cutaneous T-cell lymphoma (CTCL). The second poster
reports interim data from a Phase 1/2a trial of pralatrexate in
combination with gemcitabine in patients with relapsed or
refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's lymphoma. �We
are encouraged by these interim data which suggest that
pralatrexate has activity when administered as a single agent in
patients with CTCL and in combination with gemcitabine in patients
with lymphoma,� said Pablo J. Cagnoni, M.D., Chief Medical Officer
of Allos. �The studies will continue with the objective of
determining the optimal dose and schedule for these indications.�
Pralatrexate in CTCL (Phase 1) The poster (abstract 1569) entitled
�Pralatrexate (PDX) is Active in Cutaneous T-Cell Lymphoma:
Preliminary Results of a Multi-center Dose-finding Trial� presented
interim data from the Company�s ongoing Phase 1 trial of
pralatrexate in patients with relapsed or refractory CTCL. Data
were presented on 24 patients, including 22 evaluable patients who
completed at least one cycle of treatment at doses ranging from
10-30 mg/m2 as part of a weekly schedule for two or three weeks
followed by one week of rest. Responses were observed in 12 of 22
evaluable patients (55%), including one complete response and 11
partial responses. Patients received a median of four prior
systemic therapies. The most common adverse event was mucosal
inflammation, with Grade 1/2 mucosal inflammation observed in 11 of
24 patients and Grade 3 mucosal inflammation observed in 4 of 24
patients. There was no Grade 4 mucosal inflammation and no
thrombocytopenia above Grade 1. Up to 56 evaluable patients will be
enrolled in the study with the objective of determining the optimal
dose and schedule for pralatrexate in this patient population.
Steven Horwitz, M.D., Assistant Attending Physician, Lymphoma
Service, Memorial Sloan-Kettering Cancer Center, is the Principal
Investigator of the study. Pralatrexate and Gemcitabine in
Lymphoproliferative Malignancies (Phase 1/2a) The poster (abstract
1570) entitled �A Phase 1/2a Open-label Study of Pralatrexate and
Gemcitabine in Patients with Relapsed or Refractory
Lymphoproliferative Malignancies� presented interim data from the
Company�s ongoing Phase 1/2a open-label, multi-center study of
pralatrexate in combination with gemcitabine in patients with
relapsed or refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's
lymphoma. Data were presented on 27 patients, 22 of whom were
evaluable for response. Patients have been enrolled in eight
cohorts with different doses and schedules. Partial responses were
observed in 6 of 22 evaluable patients, including five patients on
a sequential dosing schedule and one patient on a same-day dosing
schedule. Patients received a median of three prior systemic
regimens. The most common adverse event was thrombocytopenia, with
Grade 3 observed in four patients and Grade 4 observed in seven
patients. The maximum tolerated dose for the sequential dosing
schedule was established as 10 mg/m2 of pralatrexate followed by
300 mg/m2 of gemcitabine, once every two weeks. Enrollment in the
trial is ongoing to determine the maximum tolerated dose for the
same same-day dosing schedule. Dr. Horwitz is the Principal
Investigator of the study. Reprints of the posters will be
available under the �Presentations� tab of the �Investor Relations�
section of the website (www.allos.com). About Pralatrexate (PDX)
Pralatrexate is a novel targeted antifolate designed to accumulate
preferentially in cancer cells. Based on preclinical studies, the
Company believes that pralatrexate selectively enters cells
expressing RFC-1, a protein that is over expressed on cancer cells
compared to normal cells. Once inside cancer cells, pralatrexate is
efficiently polyglutamylated, which leads to high intracellular
drug retention. Polyglutamylated pralatrexate essentially becomes
�trapped� inside cancer cells, making it less susceptible to
efflux-based drug resistance. Acting on the folate pathway,
pralatrexate interferes with DNA synthesis and triggers cancer cell
death.�The Company believes pralatrexate has the potential to be
delivered as a single agent or in combination therapy regimens.
About Cutaneous T-Cell Lymphoma Cutaneous T-cells lymphomas, or
CTCLs, are comprised of a number of non-Hodgkin's T-cell lymphomas,
including mycosis fungoides and Sezary syndrome, which have their
primary manifestations in the skin. According to the Lymphoma
Research Foundation, CTCL accounts for approximately 2% to 3% of
the estimated 63,000 new cases of non-Hodgkin's lymphoma diagnosed
each year in the United States. The Company estimates the current
annual prevalence of CTCL in the United States is between 16,000
and 20,000 cases. 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. According to the
American Cancer Society, approximately 66,000 patients are expected
to be diagnosed with NHL in the United States in 2008. About Allos
Therapeutics, Inc. Allos Therapeutics is a biopharmaceutical
company focused on developing and commercializing small molecule
therapeutics for the treatment of cancer.�The Company's lead
product candidate, pralatrexate, is a novel antifolate currently
under evaluation in a pivotal Phase 2 (PROPEL) trial in patients
with relapsed or refractory peripheral T-cell lymphoma. The PROPEL
trial is being conducted under an agreement reached with the U.S.
Food and Drug Administration under its special protocol assessment,
or SPA process. The Company is also investigating pralatrexate in
patients with non-small cell lung cancer, bladder cancer and a
range of lymphoma subtypes. The Company's other product
candidate�is RH1, a targeted chemotherapeutic agent currently being
evaluated in a Phase 1 trial in patients with advanced solid tumors
or non-Hodgkin�s lymphoma (NHL). The Company currently retains
exclusive worldwide rights to pralatrexate and RH1 for all
indications. For additional information, please visit the Company�s
website at 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 activity of pralatrexate when administered
as a single agent in patients with CTCL and in combination with
gemcitabine in patients with lymphoma, and other statements which
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 difficulties or delays in the
initiation, progress or completion of its clinical trials, whether
caused by competition, adverse events, investigative site
initiation rates, patient enrollment rates, regulatory issues or
other factors; that the interim data from the clinical trials
discussed in this press release may not be confirmed upon full
analysis of the detailed results of the trials, and may not be
predictive of future clinical trial designs or results; and that
the Company may lack the financial resources and access to capital
to fund ongoing or planned clinical trials for pralatrexate or any
of its other product candidates, or to continue evaluating their
therapeutic utility in other potential indications. 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, 2007, 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.
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