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:6/24/2016)... --  Pulmatrix, Inc ., (NASDAQ: PULM ), ... today that it was added to the Russell Microcap ... set of U.S. and global equity indexes on June ... for Pulmatrix," said Chief Executive Officer Robert Clarke ... in developing drugs for crucial unmet medical needs, and ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... ... ... crisis. Her son James, eight, was out of control. Prone to extreme mood shifts and ... him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife on ... say he was going to kill them. If we were driving on the freeway, ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
Breaking Medicine News(10 mins):