Allos Therapeutics' Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Cutaneous T-Cell Lymphoma ...
17 Juin 2010 - 3:00PM
Business Wire
Allos Therapeutics, Inc. (Nasdaq:ALTH) announced today that the
European Commission (EC) has granted orphan medicinal product
designation for pralatrexate for the treatment of cutaneous T-cell
lymphoma (CTCL). The Company is currently investigating
pralatrexate in a Phase 1 clinical study in patients with relapsed
or refractory CTCL. In addition, the Company plans to conduct a
Phase 3 clinical study comparing FOLOTYN in combination with
systemic bexarotene versus systemic bexarotene alone in patients
with CTCL who are refractory to at least one prior systemic
therapy. Prior to initiation of the Phase 3 study, the Company
will conduct a Phase 1 study to determine the maximum
tolerated dose of the combination, which the Company plans to
initiate in 2010. The EC previously granted orphan designations for
pralatrexate for the treatment of patients with peripheral T-cell
lymphoma (PTCL) and non-papillary transitional cell carcinoma (TCC)
of the urinary bladder, a form of bladder cancer.
“This orphan medicinal product designation further strengthens
our global development strategy for pralatrexate in patients with
T-cell lymphomas,” said Paul L. Berns, president and chief
executive officer of Allos Therapeutics. “CTCL is a devastating
condition that greatly impacts patients’ lives. To date,
pralatrexate has demonstrated encouraging evidence of clinical
activity in patients with relapsed or refractory CTCL and we look
forward to continuing to advance the pralatrexate development
program in this difficult-to-treat patient population.”
The European orphan medicinal product designation is intended to
promote the development of drugs that may provide significant
benefit to patients suffering from rare diseases identified as
life-threatening or very serious. Under EC legislation, orphan
medicinal product designation provides ten years of potential
market exclusivity once the product candidate is approved for
marketing for the designated indication in the European Union.
Orphan medicinal product designation also allows for protocol
assistance free of charge on clinical trials, a reduced Marketing
Authorisation Application (MAA) filing fee and the potential for
grant funding. This designation is based on a positive opinion from
the Committee for Orphan Medicinal Products (COMP) of the European
Medicines Agency (EMA).
About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma, or CTCL, is comprised of a number of
indolent non-Hodgkin’s T-cell lymphomas which have their primary
manifestations in the skin. The most common CTCL subtypes are
mycosis fungoides and Sézary syndrome. 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. The estimated annual prevalence of
CTCL is 16,000 - 20,000 cases in the U.S., 51,000 cases in the
European Union2, and 3,000 cases in Canada.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.
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 Company’s intent to
develop and conduct clinical trials for pralatrexate for the
treatment of 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. 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; 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 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 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.
Sources:
1Cutaneous Lymphoma Foundation. CTCL-MF Fast Facts.
http://clfoundation.org/publications/CL_fast_facts.pdf. Accessed
March 19, 2010.
2European Medicines Agency Committee for Orphan Medicinal
Products Public Summary of Opinion on Orphan Designation.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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