Navigation Links
Orexigen(R) Therapeutics Initiates First Clinical Trial of OREX-003 for the Mitigation of Antipsychotic-Associated Weight Gain
Date:10/2/2008

- Two Milestones Reached in Zonisamide Patent Portfolio -

SAN DIEGO, Oct. 2 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, today announced the initiation of its first clinical trial with OREX-003, a proprietary sustained release formulation of zonisamide plus olanzapine. The Phase 2a clinical trial, OZ-101, is designed to examine the effectiveness of OREX-003 in mitigating drug-associated weight gain and/or other metabolic consequences commonly experienced by patients taking atypical antipsychotic medications, as well as the potential enhancement of antipsychotic activity.

In additional Company news, the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 7,425,571 providing broad coverage of the use of zonisamide either alone or in combination with other drugs for the treatment of obesity through 2023. The USPTO has also issued U.S. Patent No. 7,429,580 which broadly covers zonisamide in combination with various marketed atypical antipsychotics including olanzapine, clozapine, risperidone, quetiapine, aripiprazole and ziprasidone through 2025. We believe that these patents complement each other and provide a strong patent portfolio for OREX-003. Orexigen has licensed both patents on an exclusive basis from Duke University.

"The initiation of the OZ-101 clinical trial and progress in securing comprehensive intellectual property coverage for zonisamide are important milestones for Orexigen as we grow our product candidate pipeline beyond our initial obesity programs by extending into other central nervous system disorders," said Gary Tollefson, M.D., Ph.D., Orexigen President and CEO. "Based on our preclinical data, we believe that OREX-003 has the potential to have an improved metabolic profile and be a more effective long-term option in the management of schizophrenia and a number of related conditions."

About OZ-101

The OZ-101 clinical trial is a double-blind, placebo-controlled clinical trial evaluating the combination of olanzapine plus zonisamide SR versus olanzapine plus placebo in 75 patients with schizophrenia over 16 weeks at nine centers in the U.S. Preclinical studies conducted by Orexigen have demonstrated that zonisamide mitigated both weight gain and elevated blood glucose associated with olanzapine through novel mechanisms. The clinical trial is currently enrolling. More information can be found at http://www.clinicaltrials.gov.

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders. The Company's lead combination product candidates targeted for obesity are Contrave(R), which is in Phase 3 clinical trials, and Empatic(TM), which is in late-stage of Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Beyond obesity, Orexigen is developing drug combinations for use in schizophrenia and obsessive-compulsive disorder. Further information about the company can be found at http://www.Orexigen.com.

Forward-Looking Statements

Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the enrollment, timing, execution and completion of clinical trials of its product candidates, the potential to obtain regulatory approval for, and effectively treat antipsychotic-associated weight gain with OREX-003, and the scope and duration of protection of issued patents relating to the Company's product candidates. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the progress and timing of the Company's clinical trials; the potential that earlier clinical trials may not be predictive of future results; the ability for the Company's product candidates to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to the Company's product candidates to delay or prevent regulatory approval or commercialization, or result in product liability claims; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.


'/>"/>
SOURCE Orexigen Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. OREXIGEN(R) Therapeutics Receives Notice of Allowance for U.S. Patent Covering the Composition of Matter in OREX-003
2. Orexigen(R) Therapeutics Schedules Webcast Discussion of Financial Results for the Second Quarter Ended June 30, 2008
3. Orexigen(R) Therapeutics to Present at Upcoming Investor Conferences
4. Orexigen(R) Therapeutics Appoints Dennis Kim, M.D., as Senior Vice President, Head of Obesity and Metabolic Disorders
5. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
6. DJO Incorporateds Pending Merger With ReAble Therapeutics Clears U.S. Antitrust Review
7. PeriCor Therapeutics Announces Closing of Licensing Agreement for Acadesine with Schering-Plough Corporation
8. Systems Medicine (SM), a Subsidiary of Cell Therapeutics, Inc. (CTI), Announces Execution of CRADA with NCI/NIH to Develop Potential Cancer Treatments Targeting the Insulin Growth Factor (IGF) Pathway
9. Amsterdam Molecular Therapeutics to Release H1 2007 Results on August 29, 2007
10. Nektar Therapeutics Appoints Tim Harkness as Chief Financial Officer
11. ExonHit Therapeutics: Allergan and ExonHits First Collaboration Compound to Begin Human Clinical Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... Jan. 20, 2017 Ginkgo Bioworks, the ... a pioneer in the synthesis and assembly of ... in assembling pathway-length synthetic DNA into Ginkgo,s automated ... in the construction of new organism designs for ... "Gen9 was founded to significantly increase the ...
(Date:1/19/2017)... and HOUSTON , Jan. ... Prenatal") today announced the formation of its Medical/Clinical ... clinicians and industry veterans who enhance the range ... it accelerates development of its novel prenatal diagnostic ... medical, clinical and strategic guidance for the company,s ...
(Date:1/19/2017)... GAITHERSBURG, Md. , Jan. 19, 2017 /PRNewswire/ ... a privately-held immunotherapeutics company targeting infectious diseases, announced ... the merger of PharmAthene and Altimmune in an ... Fund, HealthCap, Truffle Capital and Redmont Capital. The ... immunotherapeutics company with four clinical stage and one ...
(Date:1/19/2017)... ... January 19, 2017 , ... FireflySci Inc. is a go-getter ... The tremendous growth is accounted to two main factors. The first is the ... network of vendors supplying FireflySci products all around the world. , 2016 was a ...
Breaking Biology Technology:
(Date:12/22/2016)... MOUNTAIN VIEW, Calif. , Dec. 20, 2016  As ... all levels, 23andMe, the leading personal genetics company, recently released ... Only Me . The book focuses on the topics ... the Next Generation Science Standards (NGSS) taught in elementary school ... the second in a series by illustrator Ariana Killoran ...
(Date:12/20/2016)... and GENEVA, Dec, 20, 2016   Valencell , ... technology, and STMicroelectronics (NYSE: STM), a global ... electronics applications, announced today the launch of a ... biometric wearables that includes ST,s compact SensorTile ... Benchmark™ biometric sensor system. Together, SensorTile and ...
(Date:12/16/2016)... Research and Markets has announced the addition ... to 2021" report to their offering. ... The biometric vehicle access system market, ... of 14.06% from 2016 to 2021. The market is estimated to ... 854.8 Million by 2021. The growth of the biometric vehicle access ...
Breaking Biology News(10 mins):