понедельник, 2 мая 2011 г.

Ardea Biosciences, Inc. Announces Completion Of Phase 1 Clinical Trials Of Novel Investigational HIV Drug RDEA806

Ardea Biosciences,
Inc. (Pink Sheets: ARDC) announced that it has successfully completed
Phase 1 single-ascending-dose, multiple-ascending-dose, food-effect, and
drug-interaction studies of RDEA806, a novel HIV non-nucleoside reverse
transcriptase inhibitor (NNRTI), in healthy volunteers.



The data from these Phase 1 clinical trials, together with select
preclinical data, will be discussed in four poster presentations at the
47th Annual Interscience Conference on Antimicrobial Agents and
Chemotherapy (ICAAC), which is being held September 17-20 in Chicago,
Illinois. Abstracts can be accessed on the official ICAAC web site at
icaac. The poster titles and presentation details are as
follows:


-- "The Discovery of RDEA806: A Potent New HIV NNRTI in Phase 1 Clinical
Trials" will be presented during Poster Session 101 (HIV: New Drugs),
Poster Board #299, Abstract #3285, on Tuesday, September 18,
12:15-1:15 PM in Hall D.


-- "RDEA806: A Potent NNRTI with Broad Activity Against Resistant Strains
of HIV-1 and a High Genetic Barrier to Resistance" will be presented
during Poster Session 101 (HIV: New Drugs), Poster Board #300, Abstract
#1662, on Tuesday, September 18, 12:15-1:15 PM in Hall D.


-- "Safety and Pharmacokinetics of Ascending Single Oral Doses of RDEA806,
a Novel HIV NNRTI, in Healthy Volunteers" will be presented during
Poster Session 160 (Antiviral Agents), Poster Board #23, Abstract
#1609, on Wednesday, September 19, 11:15 AM-12:15 PM in Hall D.


-- "RDEA806, a Potent Non-Nucleoside Reverse Transcriptase Inhibitor with
Less Potential for Drug-Drug Interactions" will be presented during
Poster Session 160 (Antiviral Agents), Poster Board #25, Abstract
#3390, on Wednesday, September 19, 11:15 AM-12:15 PM in Hall D.



"We are very encouraged by our Phase 1 clinical trial results in
healthy volunteers. Based on these results, we plan to initiate a Phase 2a
proof-of-concept study of RDEA806 in HIV-infected patients before the end
of this year, the results of which may be available by the first quarter of
2008. Assuming positive results, a larger Phase 2b study in HIV-infected
patients could start in the second quarter of 2008," said Barry D. Quart,
PharmD, President and CEO. "ICAAC is an international conference where many
new therapeutic innovations and discoveries are first disclosed, and we
look forward to presenting our preclinical and initial clinical data on
RDEA806 at this important meeting."



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 possesses several
attractive attributes. These include: potent antiviral activity against a
wide range of HIV viral isolates, including those that are resistant to
efavirenz (Sustiva(R), Bristol-Myers Squibb) 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 is focused on the discovery and development of
small-molecule therapeutics for the treatment of viral diseases, cancer and
inflammatory diseases. The Company plans to initiate clinical studies on
four compounds this year. These include RDEA806, the Company's lead
non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of
HIV, which recently completed Phase 1 clinical trials, RDEA119, a
mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer
and inflammatory diseases, scheduled to enter Phase 1 clinical trials in
the second half of 2007, and a follow-on NNRTI and a follow-on MEK
inhibitor, both of which are scheduled to enter first-in-human studies in
the fourth quarter of 2007.



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 its goal of initiating a Phase 2 study
of RDEA806 in HIV-infected patients and initiating clinical studies on
three additional compounds this year, the expected properties and benefits
of its 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 trials,
risks related to regulatory approvals, delays in commencement of
preclinical and clinical tests, 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.

ardeabiosciences

Комментариев нет:

Отправить комментарий