Navigation Links
Lithera Initiates Phase 2b Clinical Trial of LIPO-202 Targeting Aesthetic Reduction of Subcutaneous Abdominal Fat
Date:3/12/2013

SAN DIEGO, March 12, 2013 /PRNewswire/ -- Lithera, Inc., a clinical stage pharmaceutical company focused on lifestyle and medical indications in aesthetic medicine and ophthalmology, announced today that the first patient has been treated with LIPO-202 (Salmeterol Xinafoate for Injection) in its 500-patient Phase 2b "RESET" trial.  LIPO-202, Lithera's lead product candidate, is a novel injectable pharmaceutical product designed to produce localized reduction of subcutaneous fat.

"Initiating the RESET trial is a significant milestone for Lithera and in the development of LIPO-202 as a non-ablative treatment for the aesthetic reduction of subcutaneous abdominal fat," stated George W. Mahaffey , President and CEO of Lithera.  "Following our recent Series C financing, Lithera is focused on advancing LIPO-202 in the clinic as we see tremendous potential for the drug to address a significant opportunity in aesthetic medicine – the ability to offer a quick and minimally invasive 'lunch time' procedure with no patient down time that effectively reduces abdominal fat."  

RESET is a 500-patient, multi-center, randomized, placebo-controlled clinical trial designed to measure the effects of three different doses of LIPO-202, compared to placebo, on abdominal bulging due to excess subcutaneous fat in healthy, non-obese subjects.  Patients randomized into each of the four trial arms will receive subcutaneous injections spaced evenly across the abdomen once per week for eight weeks.  Trial endpoints include multiple qualitative and quantitative measures of bulge reduction, as well as key safety information.

"The RESET trial incorporates indication-specific objective and subjective efficacy measures, as well as a suitably large sample size in order to provide what we hope to be a very clear demonstration of LIPO-202's effectiveness and a definition of its optimal dose," remarked Murray C. Maytom, MBChB, Chief Medical Officer of Lithera.  "Despite the trial's size, we expect top-line results in the third quarter of 2013 due to the short treatment duration and time to response, historically rapid trial enrollment, as well as strong interest from clinicians and patients in trial participation."

For more information on the Phase 2b trial of LIPO-202, including specific patient inclusion and exclusion criteria, please visit www.clinicaltrials.gov

About Lithera:

Lithera is a clinical stage company developing pharmaceutical and biomedical products addressing both lifestyle and medical indications in aesthetic medicine and ophthalmology. Using FDA-registered drugs approved for use in other indications, Lithera's products target and stimulate natural fat tissue metabolism to achieve non- ablative, non-surgical fat tissue reduction in specific locations. Our lead product candidate, LIPO-202 (Salmeterol Xinafoate for Injection), is a novel injectable pharmaceutical product designed to produce local, selective fat tissue reduction (pharmaceutical lipoplasty). LIPO-202 is currently under development for the aesthetic reduction of subcutaneous fat in the periumbilical area. LIPO-102 (Salmeterol Xinafoate and Fluticasone Propionate for Injection) is currently under development for the treatment of symptomatic exophthalmos (protrusion of the eye from the orbit) associated with thyroid-related eye disease (the thyroid condition is also known as Graves' Disease). Founded in 2007, the Company has assembled an exceptional team of senior executives, employees and advisors and has been financed by top-tier venture capital firms. For more information on Lithera, Inc., please visit www.lithera.com.

Lithera, LIPO-102, LIPO-202 and the Lithera logo are trademarks or registered trademarks of Lithera, Inc. Other names and brands may be claimed as the property of others.

 

Lithera, Inc.:  

Susan Knudson

Vice President, Finance & Administration

858-750-1008

sknudson@lithera.com

 

Media Inquiries:

Jason Rando / Andrew Mielach

Tiberend Strategic Advisors, Inc.

212-827-0020

jrando@tiberend.com

amielach@tiberend.com

 

 


'/>"/>
SOURCE Lithera, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Asubio Initiates Landmark Clinical Study in Spinal Cord Injury
2. CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase Inhibitor in Patients with Hereditary Angioedema
3. Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
4. Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403
5. Oncos Therapeutics Initiates Phase I Clinical Study of CGTG-102, an Oncolytic Adenovirus for the Treatment of Solid Tumor Cancers
6. MAQUET Initiates Class I Recall of the FLOW-i Anesthesia System
7. Stryker Initiates Voluntary Product Recall of Modular-Neck Stems
8. Inovio Initiates H1N1 Universal Influenza Vaccine Clinical Trial Targeting Over-65 Population, Which Represents 90% of Flu Deaths
9. Grifols Initiates Safety Study of Inhaled Alpha1-Proteinase Inhibitor (Human) Following Orphan Drug Designation for Cystic Fibrosis
10. Empire Asset Management Co. Initiates Coverage on Transcept Pharmaceuticals Inc., (NASDAQ: TSPT)
11. Karyopharm Therapeutics Initiates Two Phase 1 Trials with Oral KPT-330, the First Selective Inhibitor of Nuclear Export (SINE), in Patients with Advanced Cancers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):