Allos Therapeutics, Inc. (NASDAQ:ALTH) today reported interim
results from the Company’s ongoing Phase 1 combination study of
FOLOTYN® (pralatrexate injection) and bexarotene in patients with
relapsed or refractory cutaneous T-cell lymphoma (CTCL). The
combination treatments demonstrated encouraging activity in heavily
pre-treated patients (median of 3 prior systemic regimens). Data
were presented during an oral presentation at the Fourth Annual
T-cell Lymphoma Forum, on January 28 in San Francisco, CA.
Of the 14 patients treated to date, response data were available
for 10 patients and 4 patients have not yet reached their first
response assessment. Overall, 6 out of 10 patients achieved a
response, including one complete response and 5 partial responses.
At the maximum tolerated dose, 4 of 7 patients achieved a response,
including one complete response and 3 partial responses. Interim
data indicates that the combination regimen has been reasonably
well tolerated. The most common adverse events (AE) among the 4
patients with AE data available were dizziness, dyspnea, myalgia,
mucosal inflammation, and pyrexia (n=2 each).
“We are encouraged by the response rates and tolerability
observed at the maximum tolerated dose of the combination FOLOTYN
plus bexarotene in heavily pre-treated patients with relapsed or
refractory CTCL,” said Charles Morris, MB ChB, MRCP, chief medical
officer at Allos Therapeutics. “We look forward to completing
patient enrollment of the expanded cohort in order to further
inform the design of a planned Phase 3 registration study.”
CTCL is a group of T-cell non-Hodgkin lymphomas. In its early
stages, CTCL primarily affects the skin, causing patches, plaques,
and tumors, as well as redness and itching; however, as it
progresses, CTCL can spread to the blood, lymph nodes, and internal
organs. For some patients, their disease will progress despite
treatment with topical and skin directed therapies and will require
systemic treatments, including chemotherapies.1-2 Even when CTCL is
found in an early stage, it can be difficult to treat and usually
returns after initial treatment.2
About the Study
This ongoing, open label, multicenter, dose-finding, Phase 1
study is evaluating the combination of FOLOTYN and bexarotene in
patients with relapsed or refractory CTCL who received at least one
prior systemic therapy. The first phase of the study employed a
standard dose-escalation design to determine the maximum tolerated
dose (MTD). The maximum tolerated dose has been determined to be 15
mg/m2 of weekly FOLOTYN and 150 mg/m2 of daily bexarotene. The
cohort determined to be the optimal dose/schedule is currently at
14 patients and is being expanded to evaluate FOLOTYN and
bexarotene in a total of 30 patients at the MTD.
About FOLOTYN
FOLOTYN, a folate analogue metabolic inhibitor, was discovered
by Sloan-Kettering Institute for Cancer Research, SRI International
and Southern Research Institute and developed by Allos
Therapeutics. In May 2011, the Company entered into a strategic
collaboration agreement with Mundipharma International Corporation
Limited (Mundipharma) to co-develop FOLOTYN globally. Under the
agreement, Allos retains full commercialization rights for FOLOTYN
in the United States and Canada, with Mundipharma having exclusive
rights to commercialize FOLOTYN in all other countries.
In September 2009, the U.S. Food and Drug Administration (FDA)
granted accelerated approval for FOLOTYN for use as a single agent
for the treatment of patients with relapsed or refractory PTCL.
This indication is based on overall response rate. Clinical benefit
such as improvement in progression-free survival or overall
survival has not been demonstrated. FOLOTYN has been available to
patients in the U.S. since October 2009.
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphoma, or CTCL, is comprised of indolent
non-Hodgkin T-cell lymphomas which have their primary
manifestations in the skin. The most common CTCL subtypes are
mycosis fungoides and Sézary syndrome.1-2 The incidence of CTCL is
increasing in the United States with approximately 3,000 new cases
being diagnosed annually. CTCL affects over 30,000 in the U.S. and
Canada.3
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
approved in the U.S. for the treatment of patients with relapsed or
refractory PTCL. 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.
Fatal dermatologic reactions may occur. Dermatologic reactions
may be progressive and increase in severity with further treatment.
Patients with dermatologic reactions should be monitored closely,
and if severe, FOLOTYN should be withheld or discontinued.
Tumor lysis syndrome may occur. Monitor patients and treat if
needed.
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.
Adverse Reactions
The most common adverse reactions were mucositis (70%),
thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most
common serious adverse events are 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/sulfamethoxazole) may result
in delayed renal clearance.
Please see FOLOTYN Full Prescribing Information at
www.FOLOTYN.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 of FOLOTYN and bexarotene for the treatment of patients
with relapsed or refractory CTCL, the Company’s intent to initiate
a Phase 3 registration study of FOLOTYN and bexarotene in patients
with relapsed or refractory CTCL; 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 data from
clinical trials may not necessarily be indicative of future
clinical trial results; that the safety and/or efficacy profile for
FOLOTYN in combination with bexarotene may not support further
clinical development in relapsed or refractory CTCL; and the risk
that the Company may lack the financial resources and access to
capital to fund future clinical trials 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 September 30, 2011, 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: The Allos logo and FOLOTYN name are registered trademarks
of Allos Therapeutics, Inc.
References:
- Cutaneous Lymphoma Foundation. Fast
Facts: Cutaneous T-Cell Lymphoma.
http://www.clfoundation.org/sites/default/files/content/CTCL_2011.pdf.
Accessed January 24, 2012.
- Cutaneous Lymphoma Foundation. Fast
Facts: Sézary Syndrome.
http://www.clfoundation.org/sites/default/files/content/Fact%20Sheet_SS.pdf.
Accessed January 24, 2012.
- Accessed January 24, 2012.Cutaneous
Lymphoma Foundation. About Cutaneous T-Cell Lymphoma.
http://www.clfoundation.org/about-cutaneous-lymphoma/who-gets-cutaneous-lymphoma-and-how-many-people-have-it.
Accessed January 24, 2012.
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