OSI Pharmaceuticals Provides Update on Diabetes and Obesity Clinical Programs
May 11 2009 - 3:30PM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) provided an update
today on the progress of two early clinical programs from its
diabetes and obesity R&D operations. Phase I clinical trial
data on both PSN821 and PSN602 showed positive evidence of clinical
activity, and both candidates are now progressing to the next stage
of clinical development. PSN821 completed a single dose Phase I
trial in healthy volunteers and diabetes patients, where evidence
of glucose lowering was seen in response to a standard nutrient
challenge. PSN602 completed a Phase I trial, where indications of
activity in the form of significant reductions in food intake in
standardized meal intake assessments were seen after 14 days of
dosing in overweight/obese subjects. PSN821, an oral GPR119 agonist
being developed for the treatment of type 2 diabetes and PSN602, an
oral dual monoamine reuptake inhibitor and 5-HT1A agonist being
developed for the treatment of obesity, were discovered by OSI�s
diabetes and obesity R&D team and are wholly owned by OSI. Full
data from the PSN602 Phase I trial will be presented at a
scientific meeting in the second half of 2009.
�We are pleased with the progress we have made in the
first-in-human studies of PSN821 and PSN602,� stated Anker
Lundemose, M.D., Ph.D., President of (OSI) Prosidion. �In keeping
with our view that we should focus on establishing differentiation
early in development programs, the follow-on studies for both
PSN821 and PSN602 will include active comparator arms.�
PSN821 has progressed to a 14-day Phase I trial which may allow
a preliminary assessment of impacts on gastric emptying and glucose
data in addition to safety. Presuming continued success in this
program, OSI will initiate a follow-on 28-day dosing Phase IIa
study or a 3-month dosing Phase IIb study in 2010. The Phase II
study will include sitagliptin as a comparator. PSN602 is now
progressing with a 28-day dosing Phase IIa study, which includes
sibutramine as a comparator.
PSN821-101: Phase I
Data
In the double-blind, placebo-controlled, ascending single dose
first-in-human study, PSN821 was generally well tolerated at doses
up to 3000mg in healthy volunteers and 1000mg (the top dose tested)
in patients with type 2 diabetes, with no clinically important
adverse effects on laboratory tests, 12-lead ECGs or vital signs.
Pharmacokinetics showed a profile consistent with once or twice
daily dosing. In patients with type 2 diabetes, PSN821 showed
substantial and statistically significant reductions in glucose
responses to a standard nutrient challenge of approximately 30% at
250mg and 500mg. The data from this study was supportive of
progression of PSN821 into a 14-day dosing ascending multiple dose
study in healthy subjects and patients with type 2 diabetes and
will be submitted for presentation at a scientific meeting together
with the data from the multiple ascending dose study.
PSN602-101: Phase I
Data
In the double-blind, placebo-controlled, ascending single and
multiple dose first-in-human study, PSN602 was generally well
tolerated at doses up to 20mg daily for 14 days. At 30mg daily for
14 days, the incidence of adverse events increased and one subject
experienced syncope. There were no clinically important adverse
effects on laboratory tests, 12-lead ECGs or vital signs apart from
post-dose postural tachycardia. Pharmacokinetics showed a profile
consistent with once daily dosing. In multiple dosing over 14 days
in overweight/obese subjects, PSN602 showed substantial and
statistically significant reductions from baseline in test meal
intake of 36% and 25% at 20mg and 30mg respectively, comparing
favourably with literature values for sibutramine of 15-25%. The
data from this study is supportive of progression of PSN602 into a
28-day dosing clinical study, at a top dose of 20mg daily, with
weight loss as the primary endpoint and sibutramine as a
comparator, and will be presented at a scientific meeting.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality, novel and differentiated personalized medicines
designed to extend life and improve the quality of life for
patients with cancer and diabetes/obesity. For additional
information about OSI, please visit http://www.osip.com.
This news release contains forward-looking statements. These
statements are subject to known and unknown risks and uncertainties
that may cause actual future experience and results to differ
materially from the statements made. Factors that might cause such
a difference include, among others, OSI's and its collaborators'
abilities to effectively market and sell Tarceva and to expand the
approved indications for Tarceva, OSI�s ability to protect its
intellectual property rights, safety concerns regarding Tarceva,
competition to Tarceva and OSI�s drug candidates from other
biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission.
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