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GlaxoSmithKline And Theravance Announce Start Of Large Phase 2B ICS And LABA Studies For Asthma In The Horizon Program
GlaxoSmithKline (NYSE: GSK) and Theravance, Inc. (Nasdaq: THRX)
announced the start of large Phase 2b asthma dose-optimization studies with
both the lead inhaled corticosteroid (ICS) GW685698 ('698) and the lead
long-acting beta agonist (LABA) GW642444 ('444) assets in the 'Horizon'
program to develop a next-generation combination product.
GSK began enrolling patients with mild to severe asthma in the '698
Phase 2b clinical program on 21st December 2007 and began enrolling
patients with persistent asthma in the '444 Phase 2b clinical program on
29th December 2007. These clinical programs will determine the most
effective doses to be taken into Phase 3 combination studies. The Phase 2b
COPD program with '444 is also on schedule to commence in 1H 2008.
Darrell Baker, SVP GSK Respiratory Medicines Development Centre said,
"The program is progressing well and we are delighted to have two very
strong assets to progress into our large Phase 2b studies." He continued,
"We have seen encouraging results in previous studies and have confidence
in our ongoing program. Both asthma and COPD are serious, debilitating
diseases where there remains a considerable unmet need. We believe through
this program we will introduce a meaningful option for the treatment of
patients with these conditions."
"We are very pleased to have met the important milestone of initiating
the larger Phase 2b studies with the lead compound '444 and with the
progress of '698," said Rick E Winningham, Chief Executive Officer at
Theravance. "Based upon recent clinical and preclinical results, the
collaboration's confidence in the overall profile of '444 has increased and
we are focusing our resources on this compound to move it forward as
quickly as possible. This important step brings us closer to our joint goal
of bringing a new treatment option to patients in this important
therapeutic area."
These studies will enroll in excess of 2,400 patients recruited
globally. The '444 LABA Phase 2b dose-optimization study will enroll
approximately 600 patients with persistent asthma who are receiving inhaled
steroids. The '698 ICS Phase 2b studies will be undertaken in three
separate studies in mild, moderate and severe asthma patients with a total
enrollment of 1,800 patients. All studies will be carried out using a new
inhaler device. In parallel, enabling studies involving '444 and '698 given
in combination will be undertaken prior to commencing large-scale Phase 3
combination studies.
In a recently-completed Phase 2 study, '698 demonstrated once-a-day
efficacy in patients with moderate asthma, with significant improvements in
lung function in excess of 200mL seen within the first two weeks of dosing
and maintained throughout the remainder of the 8 week treatment period,
without any adverse effect on adrenal function (a marker of systemic
steroid effect).
Darrell Baker concluded, "Our goal will be to offer patients the
benefit of a once-daily medication to address a significant unmet patient
need. As a leader in respiratory medicine, GSK is leveraging years of
experience in the development of combination products with the goal of
providing physicians and patients with an effective and innovative
medicine."
About GSK
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies. GlaxoSmithKline is committed to
improving the quality of human life by enabling people to do more, feel
better and live longer. For company information visit http://www.gsk.com.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally
discovered product candidates. Theravance is focused on the discovery,
development and commercialization of small molecule medicines across a
number of therapeutic areas including respiratory disease, bacterial
infections and gastrointestinal motility dysfunction. Of the six programs
in development, four are in late stage -- its telavancin program focusing
on treating serious Gram-positive bacterial infections with Astellas Pharma
Inc., the Gastrointestinal Motility Dysfunction program, the Horizon
program (Beyond Advair collaboration) with GlaxoSmithKline, and TD-1792 for
the treatment of serious Gram-positive bacterial infections. By leveraging
its proprietary insight of multivalency toward drug discovery focused on
validated targets, Theravance is pursuing a next generation strategy
designed to discover superior medicines in areas of significant unmet
medical need. For more information, please visit the company's web site at
http://www.theravance.com. THERAVANCE(R), the Theravance logo, and MEDICINES THAT
MAKE A DIFFERENCE(R) are registered trademarks of Theravance, Inc.
GlaxoSmithKline Forward-Looking Statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, including
those made in this announcement, are subject to risks and uncertainties
that may cause actual results to differ materially from those projected.
Factors that may affect the Group's operations are described under 'Risk
Factors' in the Business and Prospects in the company's Annual Report on
Form 20-F for 2006.
Theravance Forward Looking Statements
This press release contains certain "forward-looking" statements as
that term is defined in the Private Securities Litigation Reform Act of
1995 regarding, among other things, statements relating to goals, plans,
objectives and future events. Theravance intends such forward-looking
statements to be covered by the safe harbor provisions for forward-looking
statements contained in Section 21E of the Exchange Act and the Private
Securities Litigation Reform Act of 1995. Examples of such statements
include statements relating to the goals, timing and expected results of
clinical and preclinical studies, statements regarding the potential
benefits and mechanisms of action of drug candidates, statements concerning
the goals and timing of seeking regulatory approval of our product
candidates, the enabling capabilities of Theravance's approach to drug
discovery and its proprietary insights, statements concerning expectations
for product candidates through development and commercialization and
projections of revenue and other financial items. These statements are
based on the current estimates and assumptions of the management of
Theravance as of the date of this press release and are subject to risks,
uncertainties, changes in circumstances, assumptions and other factors that
may cause the actual results of Theravance to be materially different from
those reflected in its forward-looking statements. Important factors that
could cause actual results to differ materially from those indicated by
such forward-looking statements include, among others, the potential that
results of clinical or preclinical studies indicate product candidates are
unsafe, ineffective, inferior or not superior, and delays or failure to
achieve regulatory approvals and risks of collaborating with third parties
to develop and commercialize products. These and other risks are described
in greater detail under the heading "Risk Factors" contained in Item 1A of
Theravance's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on November 7, 2007 and the risks discussed in
our other filings with the SEC. Given these uncertainties, you should not
place undue reliance on these forward-looking statements. Theravance
assumes no obligation to update its forward-looking statements.
GlaxoSmithKline
http://www.gsk.com
GlaxoSmithKline ªi Theravance Anunþarea Start mari Faza 2B ICS ºi LABA studii pentru Astm În orizontul de Program - GlaxoSmithKline And Theravance Announce Start Of Large Phase 2B ICS And LABA Studies For Asthma In The Horizon Program - articole medicale engleza - startsanatate