Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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From Jul 2019 to Jul 2024
Allos Therapeutics, Inc. (Nasdaq: ALTH), a biopharmaceutical company
focused on the development and commercialization of small molecule
therapeutics for the treatment of cancer, today announced that the U.S.
Food and Drug Administration (FDA) granted orphan drug designation to
the Company's novel antifolate, pralatrexate (PDX), for the treatment of
patients with diffuse large B-cell lymphoma.
"We are pleased with this designation, which highlights the need for
novel therapies to treat lymphoma,” said Paul L. Berns, President and
Chief Executive Officer. “Pralatrexate previously received orphan drug
designation from the FDA for the treatment of patients with T-cell
lymphoma. This additional designation reinforces our intention to
further evaluate pralatrexate as a potential treatment for patients with
B-cell lymphoma.”
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 Pralatrexate (PDX)
PDX is a novel, small molecule chemotherapeutic agent that inhibits
dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme
involved in the building of nucleic acid, or DNA, and other processes.
PDX was rationally designed for efficient transport into tumor cells via
the reduced folate carrier, or RFC-1, and effective intracellular drug
retention. The Company believes these biochemical features, together
with preclinical and clinical data in a variety of tumors, suggest that
PDX may have a favorable safety and efficacy profile relative to
methotrexate and other related DHFR inhibitors. The Company believes PDX
has the potential to be delivered as a single agent or in combination
therapy regimens.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on developing
and commercializing small molecule therapeutics for the treatment of
cancer. The Company's lead product candidate, pralatrexate (PDX), is a
novel antifolate currently under evaluation in a pivotal Phase 2
(PROPEL) trial in patients with relapsed or refractory peripheral T-cell
lymphoma. The PROPEL trial is being conducted under an agreement reached
with the U.S. Food and Drug Administration under its special protocol
assessment, or SPA process. The Company is also investigating
pralatrexate in patients with non-small cell lung cancer, bladder cancer
and a range of lymphoma subtypes. The Company's other product
candidate is RH1, a targeted chemotherapeutic agent currently being
evaluated in a Phase 1 trial in patients with advanced solid tumors or
non-Hodgkin’s Lymphoma (NHL). The Company currently retains exclusive
worldwide rights to pralatrexate and RH1 for all indications. For
additional information, please visit the Company’s website 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. Such forward-looking statements include
statements regarding the potential safety and efficacy profile of
pralatrexate for the treatment of lymphoma 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. These risks and
uncertainties include, among others: that the Company may experience
delays in the completion of clinical trials, whether caused by adverse
events, regulatory issues or other factors; that clinical trials may not
demonstrate that pralatrexate is both safe and effective for the
treatment of patients with lymphoma, relapsed or refractory PTCL, or any
other type of cancer; that data from preclinical studies and clinical
trials may not necessarily be indicative of future clinical trial
results; that the safety and/or efficacy results of clinical trials for
pralatrexate will not support an application for marketing approval in
the United States or any other country; and that the Company may lack
the financial resources and access to capital to fund future clinical
trials for pralatrexate or any of its other product candidates.
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 Annual Report on Form 10-K for the year ended December 31,
2007 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.