Allos Therapeutics’ FOLOTYN™ Shows Activity in a Dose Finding Phase 1 Study of Relapsed or Refractory Cutaneous T-Cell Ly...
08 Décembre 2009 - 3:15PM
Business Wire
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). These data were showcased during
an oral presentation at the 51st Annual Meeting of the American
Society of Hematology (ASH) in New Orleans, LA.
Data were presented on 31 patients with relapsed or refractory
CTCL who received a median of 4 prior systemic therapies. The
dosing regimen of 15 mg/m2 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. In this dose
de-escalating study, 18 patients who received FOLOTYN at the
optimal dose or higher, responses were observed in 11 patients
(61%). In the overall study, which included doses lower than the
optimal dose, responses were observed in 12 patients (39%),
including two complete responses and nine partial responses in
patients who received FOLOTYN. An expansion cohort at the optimal
dose of 15 mg/m2 weekly for three out of a four week cycle is
actively enrolling.
“We really need new therapies for our patients with relapsed or
refractory CTCL,” said Steven Horwitz, M.D., assistant attending,
medical oncologist, Memorial Sloan-Kettering Cancer Center, who is
serving as the study chair. “We are encouraged by the responses
we’ve seen so far. Many of these patients have had excellent
responses, even at relatively low doses of pralatrexate.”
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 study employed a dose de-escalating strategy
to determine an active, well tolerated dose and schedule of FOLOTYN
in this population. To date, 31 patients with CTCL have received
FOLOTYN, including 18 (58%) men and 13 (42%) women, with a median
age of 57 years. Patients were randomized into various dosing
regimens to determine the optimal dose and schedule.
The most common Grade 3 adverse events were stomatitis (13%).
The incidence of hematological adverse events were low with
thrombocytopenia (3%) and neutropenia (3%) observed in one patient.
No Grade 4 adverse events were observed. The most common adverse
events, any grade, were nausea (52%) and fatigue (48%).
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphomas, or CTCLs, are comprised of a number
of 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.
Allos is also exploring the potential of FOLOTYN in other
indications. Allos retains exclusive worldwide rights to FOLOTYN
for all indications. Allos is headquartered in Westminster, CO. For
additional information, please visit 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 for FOLOTYN
to provide clinical benefit to patients with relapsed or refractory
CTCL or any other type of cancer; 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 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 Quarterly Report on
Form 10-Q for the quarter ended September 30, 2009, 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 trademarks of Allos
Therapeutics, Inc.
Source:
1Cutaneous Lymphoma Foundation. CTCL-MF
fast facts. http://clfoundation.org/publications/CL_fast_facts.pdf.
Accessed December 6, 2009.
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