Allos Therapeutics Announces Interim Data from Phase 1 Study of PDX in Patients with Relapsed or Refractory Cutaneous T-Cell Lym
05 Junho 2008 - 4:00PM
Business Wire
Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced the
presentation of interim data from its Phase 1 study of PDX
(pralatrexate) with vitamin B12 and folic acid supplementation in
patients with relapsed or refractory cutaneous T-cell lymphoma
(CTCL), at the 10th International Conference on Malignant Lymphoma
in Lugano, Switzerland, June 4-7, 2008. Data were presented on 17
patients, including 14 evaluable patients who completed at least
one cycle of treatment with PDX at doses ranging from 15 - 30 mg/m2
as part of a weekly schedule for two or three weeks followed by one
week of rest. Patients received a median of three prior systemic
therapies. In this Phase 1 dose optimization study,
investigator-assessed responses were observed in seven of 14
evaluable patients (50%), including two complete responses and five
partial responses. Responses were observed in all four treatment
cohorts. The most common adverse event was mucositis, with Grade 2
mucositis observed in six of 17 patients and Grade 3 mucositis
observed in two of 17 patients. There were no Grade 4 toxicities
and no thrombocytopenia above Grade 1. �We are encouraged by these
data, in which PDX has shown activity at a range of doses in
patients with relapsed or refractory CTCL,� said Pablo J. Cagnoni,
M.D., Chief Medical Officer of Allos. �The study will continue with
the objective of determining the optimal dose and schedule for PDX
in this patient population.� The interim data were presented in a
poster session on Thursday, June 5, 2008. To view a copy of the
poster, visit the �Presentations� page under the �Investor/Media�
section of the Company�s website at www.allos.com. In this Phase 1
open-label multi-center study, patients with either relapsed or
refractory CTCL receive PDX as part of a weekly schedule for two or
three weeks followed by one week of rest. In the first cohort,
patients received starting doses of PDX at 30 mg/m2, with dose
reduction in subsequent cohorts based on toxicity. Up to 56
evaluable patients will be enrolled in the study with the objective
of determining the optimal dose and schedule for PDX in this
patient population. A total of 20 of these patients will be
enrolled at what is determined to be the optimal dose and schedule.
Steven Horwitz, M.D., Assistant Attending Physician, Lymphoma
Service, Memorial Sloan-Kettering Cancer Center, is serving as the
study chair. Information regarding this study is available at the
U.S. government�s clinical trials database at
http://www.clinicaltrials.gov. 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 PDX
(pralatrexate) PDX is a novel, small molecule chemotherapeutic
agent that inhibits dihydrofolate reductase, or DHFR, a folic acid
(folate)-dependent enzyme involved in the building of nucleic acid,
or DNA, and other processes. PDX was rationally designed for
efficient transport into tumor cells via the reduced folate
carrier, or RFC-1, and effective intracellular drug retention. The
Company believes these biochemical features, together with
preclinical and clinical data in a variety of tumors, suggest that
PDX may have a favorable safety and efficacy profile relative to
methotrexate and certain other DHFR inhibitors. The FDA has granted
orphan drug status and fast track designation to PDX for the
treatment of patients with T-cell lymphoma. About Allos
Therapeutics, Inc. Allos Therapeutics is a biopharmaceutical
company focused on developing and commercializing innovative small
molecule drugs for the treatment of cancer.�The Company's lead
product candidate, PDX (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 PDX
in patients with non-small cell lung cancer and a range of lymphoma
sub-types. The Company's other product candidate�is RH1, a targeted
chemotherapeutic agent currently under evaluation in a Phase 1
trial in patients with advanced solid tumors or non-Hodgkin�s
lymphoma (NHL). 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 regarding the potential safety and efficacy
profile of PDX for the treatment of CTCL or any other type of
cancer; the potential safety and efficacy profile of PDX relative
to methotrexate and other related DHFR inhibitors; 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 Phase 1 CTCL study, 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 relapsed or refractory CTCL or any other type of cancer; that
the interim data from the Phase 1 CTCL study may not be confirmed
upon full analysis of the detailed results of the study, 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 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, 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.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Gráfico Histórico do Ativo
De Set 2024 até Out 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Gráfico Histórico do Ativo
De Out 2023 até Out 2024