Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced updated
data from its ongoing dose finding Phase 1 study of FOLOTYN®
(pralatrexate injection) in patients with relapsed or refractory
cutaneous T-cell lymphoma (CTCL), a group of often slow-growing
non-Hodgkins lymphomas that primarily manifest in the skin. These
data were presented during a poster presentation at the European
Hematology Association (EHA) meeting being held June 10-13, 2010 in
Barcelona, Spain.
Of the 54 patients enrolled in this dose de-escalation study,
data were available for 48 patients with relapsed or refractory
CTCL who received a median of 4 prior systemic therapies. FOLOTYN
administered at 15 mg/m2 via IV push weekly for three weeks out of
a four-week cycle was determined to be the optimal starting dose
and schedule that provided activity with tolerability. Of the 29
patients who received FOLOTYN at the optimal dose, 22 were
evaluable for efficacy and 23 were evaluable for safety. The
response rate for patients treated at the optimal dose was 45%
(10/22). Of the patients who received FOLOTYN at the optimal dose
or higher, 53% (18/34) achieved a response, including one complete
response and 17 partial responses. In a subgroup analysis,
responses to FOLOTYN were observed in patients who had failed key
prior systemic therapies, including 42% (10/24) of patients who
failed prior oral bexarotene, 40% (4/10) of methotrexate failures,
35% (7/20) of patients who failed HDAC inhibitors, and 24% (4/17)
of interferon failures. FOLOTYN was well tolerated at the optimal
dose, with forty-eight percent (11/23) of patients experiencing at
least one adverse event. The only grade 3 adverse event observed
was mucositis in 17% (4/23) of patients. No grade 4 adverse events
were observed at the optimal dose. The most common adverse events,
any grade, were mucositis (39% grade 1-3), nausea (22% grade 1-2)
and fatigue (17% grade 1-2).
“CTCL is often an indolent disease, thus the goal of this trial
was to identify an optimal dose with good activity and acceptable
toxicity to allow continuous or maintenance treatment,” said
Charles Morris, MB ChB, MRCP, chief medical officer at Allos
Therapeutics, Inc. "We are encouraged by the consistent, high
response rates and tolerability achieved at the optimal dose in
this heavily pre-treated relapsed or refractory CTCL patient
population. We look forward to completing patient follow up in this
study and to further clinical evaluation of FOLOTYN as a potential
treatment option for patients with CTCL."
About the Study
This ongoing, open-label, multi-center, dose finding Phase 1
study is evaluating FOLOTYN in patients with relapsed or refractory
cutaneous T-cell lymphoma (CTCL) who received at least one prior
systemic therapy. The first phase of the study employed a dose
de-escalating strategy to determine an active, well-tolerated dose
and schedule of FOLOTYN in this population. Patients were
randomized into various dosing regimens to determine the optimal
dose and schedule. Once the maximum tolerated dose (MTD) was
determined at 15 mg/m2 weekly for three weeks out of a four-week
cycle, this MTD cohort was expanded to include a total of 29
patients. Patient enrollment in the expanded cohort has been
completed and patient follow-up is ongoing to assess final efficacy
and tolerability.
About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphomas, or CTCLs, are comprised of a number
of indolent non-Hodgkin's T-cell lymphomas, including mycosis
fungoides and Sézary 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 66,000 new cases of non-Hodgkin's lymphoma diagnosed each
year in the United States. According to the Cutaneous Lymphoma
Foundation, the estimated annual prevalence of CTCL in the United
States is between 16,000 and 20,000 cases.1
About Allos Therapeutics
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. Allos is currently focused on
the development and commercialization of FOLOTYN® (pralatrexate
injection), a folate analogue metabolic inhibitor. FOLOTYN is the
first and only drug approved in the U.S. for the treatment of
patients with relapsed or refractory peripheral T-cell lymphoma.
The FDA approved FOLOTYN under the agency’s accelerated approval
process. Allos is also developing FOLOTYN in other potential
indications. Allos retains exclusive worldwide rights to FOLOTYN
for all indications. Allos is headquartered in Westminster, Colo.
For additional information, please visit www.allos.com.
Important Safety Information
Warnings and Precautions:
FOLOTYN may suppress bone marrow function, manifested by
thrombocytopenia, neutropenia, and anemia. Monitor blood counts and
omit or modify dose for hematologic toxicities.
Mucositis may occur. If ≥ Grade 2 mucositis is observed, omit or
modify dose.
Patients should be instructed to take folic acid and receive
vitamin B12 to potentially reduce treatment-related hematological
toxicity and mucositis.
FOLOTYN can cause fetal harm. Women should avoid becoming
pregnant while being treated with FOLOTYN, and pregnant women
should be informed of the potential harm to the fetus.
Use caution and monitor patients when administering FOLOTYN to
patients with moderate to severe renal function impairment.
Elevated liver function test abnormalities may occur and require
monitoring. If liver function test abnormalities are ≥ Grade 3,
omit or modify dose.
Dermatologic reactions may occur. Patients with dermatologic
reactions should be monitored closely.
Adverse Reactions:
The most common adverse reactions observed were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events were pyrexia, mucositis, sepsis,
febrile neutropenia, dehydration, dyspnea and thrombocytopenia.
Use in Specific Patient Population:
Nursing mothers should be advised to discontinue nursing or the
drug, taking into consideration the importance of the drug to the
mother.
Drug Interactions:
Co-administration of drugs subject to renal clearance (e.g.,
probenecid, NSAIDs, and trimethoprim/sulfamethaxazole) may result
in delayed renal clearance.
For additional important safety information, please see the full
prescribing information for FOLOTYN 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. These forward-looking
statements include, but are not limited to, statements regarding
the estimated incidence of CTCL in the U.S.; Allos' future product
development and regulatory strategies, including its intent to
develop or seek regulatory approval for FOLOTYN in CTCL and other
additional indications; 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. Important factors
that may cause actual results to differ materially include, but are
not limited to, that Allos 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; and that Allos may lack the financial resources and
access to capital to support its future operations, including its
product development and commercialization plans for FOLOTYN.
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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2010, 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 Allos on the date hereof, and Allos 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: The Allos logo and FOLOTYN name are trademarks of Allos
Therapeutics, Inc.
References:
1. Cutaneous Lymphoma Foundation. CTCL-MF
fast facts http://clfoundation.org/publications/CL_fast_facts.pdf.
Accessed June 4, 2010.
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