Allos Therapeutics Announces Updated Data from Pivotol Phase 2 PROPEL Study of Pralatrexate to be Presented at ASCO 2009
15 5월 2009 - 7:15AM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that
updated data from its pivotal Phase 2 PROPEL study of pralatrexate
in patients with relapsed or refractory peripheral T-cell lymphoma
will be presented at the 45th Annual Meeting of the American
Society of Clinical Oncology (ASCO) to be held in Orlando, Fla.,
from May 29 to June�2, 2009.
The final results from the PROPEL study were reported in early
February and formed the basis of the Company�s New Drug Application
(NDA), which was submitted to the U.S. Food and Drug Administration
(FDA) in March 2009. The poster presentation at ASCO will include
analyses of response rate and durability of response, as well as
overall survival.
Presentation details are as follows:
Date/Time:
� Saturday, May 30, 2009, 8:00 a.m. - 12:00 p.m. (Eastern)
Track:
Lymphoma and Plasma Cell Disorders
Poster Title:
PROPEL: Results of the Pivotal, Multi-center, Phase 2 Study of
Pralatrexate in Patients with Relapsed or Refractory Peripheral
T-cell Lymphoma (PTCL)
Abstract Number:
8561
Location:
Level 2, West Hall C, Poster Board R6 �
About Pralatrexate
Pralatrexate is a targeted antifolate designed to accumulate
preferentially in cancer cells. Based on preclinical studies, the
Company believes that pralatrexate selectively enters cells
expressing RFC-1, a protein that is over-expressed on cancer cells
compared to normal cells. Once inside cancer cells, pralatrexate is
efficiently polyglutamylated, which leads to high intracellular
drug retention. Polyglutamylated pralatrexate essentially becomes
�trapped� inside cancer cells, making it less susceptible to
efflux-based drug resistance. Acting on the folate pathway,
pralatrexate interferes with DNA synthesis and triggers cancer cell
death.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on
developing and commercializing innovative small molecule drugs for
the treatment of cancer. The Company�s lead product candidate,
pralatrexate, is a novel targeted antifolate designed to accumulate
preferentially in cancer cells. In February 2009, the Company
announced the final results from PROPEL, the Company�s pivotal
Phase 2 (PROPEL) trial of pralatrexate in patients with relapsed or
refractory peripheral T-cell lymphoma (PTCL). The PROPEL trial was
conducted under an agreement reached with the U.S. Food and Drug
Administration under its special protocol assessment (SPA) process.
Based on the results of the PROPEL trial, the Company submitted a
New Drug Application to the U.S. Food and Drug Administration for
pralatrexate for the treatment of relapsed or refractory PTCL in
March 2009. The Company is also investigating pralatrexate in
patients with non-small cell lung cancer, bladder cancer and a
range of lymphoma sub-types. The Company currently retains
exclusive worldwide rights to pralatrexate for all indications. For
additional information, please visit www.allos.com.
Safe Harbor Statement
The anticipated presentation will contain forward-looking
statements that involve significant risks and uncertainties.
Additional information concerning these forward-looking statements
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 Dec. 31, 2008, 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
the presentation. All forward-looking statements are based on
information currently available to the Company on the date thereof,
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)
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