Allos Therapeutics’ Pralatrexate Granted FDA Orphan Drug Designation for the Treatment of Bladder Cancer
18 Maio 2010 - 9:00AM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the
U.S. Food and Drug Administration (FDA) has granted orphan drug
designation to pralatrexate for the treatment of advanced or
metastatic transitional cell carcinoma (TCC) of the urinary
bladder, a form of bladder cancer. The Company is currently
investigating pralatrexate in a Phase 2 clinical study in patients
with advanced or metastatic relapsed TCC of the urinary
bladder.
"We are pleased that the FDA has recognized the unmet medical
need for effective new therapies for the treatment of patients with
advanced or metastatic transitional cell carcinoma of the urinary
bladder, which is a very difficult disease," said Paul L. Berns,
president and chief executive officer. "This orphan drug
designation supports our development strategy for pralatrexate, and
we look forward to completing patient enrollment in our ongoing
Phase 2 study of pralatrexate in this patient population.”
The U.S. Orphan Drug Act is intended to assist and encourage
companies to develop safe and effective therapies for the treatment
of rare diseases and disorders. Under the Orphan Drug Act, the FDA
will not accept or approve other marketing applications from other
sponsors to market the identical active moiety for the same
therapeutic indication for a seven-year period once a designated
orphan drug is approved for marketing. In addition to potential
market exclusivity, orphan drug designation provides potential
protocol assistance, advice on the conduct of clinical trials, tax
credits for clinical research expenses, grant funding for research
of rare disease treatments and waiver of the Prescription Drug User
Fee Act (PDUFA) filing fee for the drug's sponsor.
About Bladder Cancer
Advanced or metastatic TCC of the urinary bladder is a
life-threatening condition. According to the American Cancer
Society, an estimated 70,980 new cases of bladder cancer were
expected to be diagnosed in the United States in 2009. Transitional
cell carcinoma, or TCC, is the most common form of bladder cancer,
accounting for more than 97% of all bladder cancers. There are
currently no approved agents in the United States for the treatment
of advanced or metastatic relapsed TCC of the urinary bladder.
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 pralatrexate, a folate
analogue metabolic inhibitor. Pralatrexate, which is marketed in
the U.S. as 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 developing pralatrexate
in other potential indications. Allos retains exclusive worldwide
rights to pralatrexate 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 future
product development and regulatory strategies, including its intent
to develop or seek regulatory approval for pralatrexate in specific
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 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 to continue evaluating
its 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.
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