Allos Therapeutics' Pralatrexate Granted Orphan Medicinal Product Designation for the Treatment of Hodgkin Lymphoma by the Eu...
15 10월 2010 - 10:00PM
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 Hodgkin lymphoma
(HL). The Company is currently investigating pralatrexate in a
number of ongoing studies, including a Phase 2 clinical study in
patients with relapsed or refractory non-Hodgkin lymphoma or
Hodgkin lymphoma. The EC previously granted orphan designations for
pralatrexate for the treatment of patients with peripheral T-cell
lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and non-papillary
transitional cell carcinoma (TCC) of the urinary bladder, a form of
bladder cancer.
Charles Morris, MB ChB, MRCP, chief medical officer at Allos
Therapeutics, said: “The orphan medicinal product designation
represents another important regulatory achievement for Allos and
further strengthens our global development strategy for
pralatrexate in patients with hematologic malignancies.”
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 Hodgkin Lymphoma (HL)
Hodgkin lymphoma is a type of cancer of the lymphatic system, a
network of vessels that transport fluid from tissues through the
lymph nodes and into the bloodstream. Because lymph nodes are found
throughout the body, the cancer can begin in almost any part of the
body. Many people with HL can be cured if the disease is found and
treated early. However, despite the treatments available, HL
remains a serious and life-threatening disease, mainly because it
is associated with poor survival in patients whose disease does not
respond to treatment or has come back after previous treatment. HL
affects approximately 1.1 in 10,000 people in the European Union.*1
The National Cancer Institute estimated that approximately 8,490
new cases of HL were expected to be diagnosed in the United States
in 2010.
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 developing FOLOTYN in other hematologic malignancies
and solid tumors. 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 Company’s intent to
develop and conduct clinical trials for pralatrexate for the
treatment of patients with Hodgkin lymphoma; 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 June 30, 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.
*Disclaimer: For the purpose of the designation, the number of
patients affected by the condition is estimated and assessed on the
basis of data from the European Union (EU 27), Norway, Iceland and
Liechtenstein. This represents a population of 506,500,000
(Eurostat 2010).
Source:
1European Medicines Agency Committee for Orphan Medicinal
Products Public summary of opinion on orphan designation,
Pralatrexate for the treatment of Hodgkin lymphoma.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
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