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Ardea Biosciences Reports Positive Phase 2a Results For Lead HIV Candidate, RDEA806, Demonstrating Up To 2.0 Log Reduction In Plasma Viral Load
Ardea Biosciences, Inc.
(Nasdaq: RDEA) announced positive preliminary results from its
ongoing Phase 2a proof-of-concept study of RDEA806, its novel
investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in
patients with human immunodeficiency virus (HIV).
Preliminary results from the first two of three cohorts demonstrate
that the oral dosing regimens tested so far produce robust reductions in
plasma viral load and are well tolerated.
"These preliminary data, together with RDEA806's unique activity
against resistant HIV in vitro and extensive safety experience, indicate
that RDEA806 is a highly potent antiretroviral that warrants further study
for both treatment-naive and treatment-experienced HIV patients," said
Graeme Moyle, MBBS, MD, Director of HIV Research, Chelsea and Westminster
Hospital, who is conducting the Phase 2a study and assisting with the
design of the Phase 2b study.
Phase 2a Clinical Trial Design & Preliminary Results
The Phase 2a, randomized, double-blind, placebo-controlled trial is
evaluating the antiviral activity, pharmacokinetics, safety and
tolerability of RDEA806 versus placebo in 36 HIV-positive patients who are
naive to antiretroviral treatment. Nine out of 12 patients in each of three
cohorts will receive RDEA806. The primary efficacy endpoint is the change
from baseline in plasma viral load. Preliminary results, which include
those from the first ten evaluable patients in the 400mg twice daily cohort
and the first eight evaluable patients in the 600mg once daily cohort,
showed the following:
-- Patients receiving 400mg twice daily had a 2.0 log placebo-adjusted
mean reduction in plasma viral load.
-- Patients receiving 600 mg once daily had a 1.7 log placebo-adjusted
mean reduction in plasma viral load.
-- There were no serious adverse events reported in either cohort.
-- There were no ECG-related adverse events reported in either cohort.
-- There were no discontinuations in either cohort.
-- None of the typical side effects associated with other NNRTIs were
reported in either cohort, such as drug-related rash or abnormal
dreams.
-- The percentage of patients with adverse events that were possibly
drug-related was lower in patients receiving drug than in those
receiving placebo.
A recently conducted single-dose human bioavailability study of a new
enteric-coated tablet formulation of RDEA806 demonstrated increased trough
plasma concentrations after 24 hours and greater flexibility in dosing,
with the potential for dosing with or without meals. The 80% drug loading
in these tablets also improves our ability to co-formulate RDEA806 with
other antivirals. The Company plans to evaluate this improved formulation
at a dose of 800 mg once daily in a third cohort of its Phase 2a study and
advance this formulation into its planned Phase 2b study.
"The viral load reductions observed with RDEA806 are among the largest
observed in short-term monotherapy studies of an HIV antiviral, including
those of other marketed or investigational NNRTIs and raltegravir
(ISENTRESS(TM); Merck)," said Barry D. Quart, PharmD, Ardea's President and
CEO. "Based on these positive results, together with the recent successful
completion of our new formulation and three-month toxicology studies, we
plan to initiate a multi-national Phase 2b study comparing RDEA806 to
efavirenz (SUSTIVA(R); Bristol-Myers Squibb) in first-line patients in the
second quarter of this year."
About RDEA806
RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor
(NNRTI) for the potential treatment of HIV infection. Based on preclinical
and clinical studies to-date, Ardea believes that RDEA806 may have
important competitive advantages. These include the potential for potent
antiviral activity against a wide range of HIV viral isolates, including
those that are resistant to efavirenz (SUSTIVA(R)) and other currently
available NNRTIs; a high genetic barrier to resistance; the potential to be
administered in a patient-friendly, oral dosing regimen; limited
pharmacokinetic interactions with other drugs; and the ability to be
co-formulated with other HIV antiviral drugs.
About Ardea Biosciences, Inc.
Ardea Biosciences, of San Diego, California, is a biotechnology company
focused on the discovery and development of small-molecule therapeutics for
the treatment of HIV, cancer and inflammatory diseases, including gout. The
Company has two product candidates in clinical development and several
others in preclinical development. Ardea's most advanced clinical
development candidate is RDEA806, a non-nucleoside reverse transcriptase
inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV.
In addition, the Company is investigating RDEA806 for the treatment of
gout. The Company's lead mitogen-activated ERK kinase (MEK) inhibitor,
RDEA119, is in a Phase 1 study in advanced cancer patients and is being
investigated for the treatment of inflammatory diseases. Ardea also is
developing a next-generation NNRTI for HIV and a next-generation MEK
inhibitor for both cancer and inflammatory diseases.
Statements contained in this press release regarding matters that are
not historical facts are "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking
statements. Such statements include, but are not limited to, statements
regarding: Ardea's goals, including the expected properties and benefits of
RDEA806 and RDEA119 and its other compounds and the results of clinical and
other studies. Risks that contribute to the uncertain nature of the
forward-looking statements include: risks related to the outcomes of
preclinical and clinical studies, risks related to regulatory approvals,
delays in commencement of preclinical and clinical studies, and costs
associated with internal development and in-licensing activities. These and
other risks and uncertainties are described more fully in Ardea's most
recently filed SEC documents, including its Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All
forward-looking statements contained in this press release speak only as of
the date on which they were made. Ardea undertakes no obligation to update
such statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Ardea Biosciences, Inc.
http://www.ardeabio.com
View drug information on Isentress; Sustiva.
Ardea Biotehnologie rapoarte de faza 2a rezultate pozitive pentru HIV, duce candidate, RDEA806, sã demonstreze pânã la 2.0 jurnalul de reducere a încãrcãturii virale în plasmã - Ardea Biosciences Reports Positive Phase 2a Results For Lead HIV Candidate, RDEA806, Demonstrating Up To 2.0 Log Reduction In Plasma Viral Load - articole medicale engleza - startsanatate