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Allos Therapeutics Initiates Study Of PDX In Patients With Cutaneous T-Cell Lymphoma
Allos
Therapeutics, Inc. (Nasdaq: ALTH) today announced the initiation of patient
enrollment in a Phase 1, open-label, multi-center study of the Company's
novel antifolate PDX (pralatrexate) with vitamin B12 and folic acid
supplementation in patients with relapsed or refractory cutaneous T-cell
lymphoma (CTCL).
"Based on our experience with PDX in patients with peripheral T-cell
lymphoma, we're excited to initiate this study in patients with cutaneous
T- cell lymphoma and view this effort as a natural progression of our PDX
development program in hematologic malignancies," said Pablo J. Cagnoni,
M.D., Chief Medical Officer of Allos. "Therapies currently used to treat
cutaneous T-cell lymphoma fail to produce durable remissions in the
majority of patients with advanced disease."
In this study, patients with either relapsed or refractory cutaneous T-
cell lymphoma will receive PDX as part of a weekly schedule for two or
three weeks followed by one week of rest. Patients will receive starting
doses of PDX at 30 mg/m2, with dose reduction in subsequent cohorts based
on toxicity. Up to 56 evaluable patients will be enrolled in the study with
the objective of determining the optimal dose and safety profile of PDX in
this population. A total of 20 of these patients will be enrolled at what
is determined to be the optimal dose and schedule. Steven Horwitz, M.D.,
Assistant Attending Physician, Lymphoma Service, Memorial Sloan-Kettering
Cancer Center, will serve as the study chair.
"Given the evidence of activity observed to date with PDX in patients
with aggressive T-cell lymphomas, coupled with the common cell lineage
between PTCL and CTCL, there is a strong clinical rationale to pursue
development of PDX in this setting," said Dr. Horwitz.
Information regarding this study is available at http://www.allos.com or the
U.S. government's clinical trials database at
http://www.clinicaltrials.gov.
About Cutaneous T-cell Lymphoma
The cutaneous T-cells lymphomas are comprised of a number of
non-Hodgkins T-cell lymphomas, including mycosis fungoides and Sezary
syndrome, which have their primary manifestations in the skin. According to
the Lymphoma Research Foundation, CTCL comprises about 2% to 3% of the
estimated 63,000 new cases of non-Hodgkin's lymphoma diagnosed annually.
About PDX (pralatrexate)
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. We believe 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 certain
other DHFR inhibitors.
About Allos Therapeutics, Inc.
Allos Therapeutics is a biopharmaceutical company focused on the
development and commercialization of small molecule therapeutics for the
treatment of cancer. The company's lead product candidate, PDX
(pralatrexate), is a novel antifolate currently under evaluation in a
pivotal Phase 2 trial in patients with relapsed or refractory peripheral
T-cell lymphoma. The company is also investigating PDX in patients with
non-small cell lung cancer and a range of other lymphoma sub-types. The
Company's other product candidate is RH1, a targeted chemotherapeutic
agent, for which the company expects to initiate a Phase 1 trial in
patients with advanced solid tumors in the second half of 2007. For
additional information, please visit the Company's website at
http://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
relating to the potential safety and efficacy profile of PDX for the
treatment of CTCL 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 this Phase I trial, whether caused
by competition, adverse events, patient enrollment rates, regulatory issues
or other factors; that clinical trials may not demonstrate that PDX is both
safe and more effective than current standards of care; 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 PDX will not support an application for marketing
approval in the United States or any other country; and the risk that the
Company may lack the financial resources and access to capital to fund
future clinical trials for PDX 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,
2006 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.
The Allos logo is a trademark of Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
http://www.allos.com
Allos therapeutics iniþiazã studiu de pdx cutanate la pacienþii cu limfom cu celule T - - Allos Therapeutics Initiates Study Of PDX In Patients With Cutaneous T-Cell Lymphoma - articole medicale engleza - startsanatate