BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

La Jolla Pharmaceutical Company (LJPC) Announces Complete Enrollment Of Phase 2 Clinical Trial Of GCS-100 In Chronic Kidney Disease


12/16/2013 9:45:27 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

SAN DIEGO, CA--(Marketwired - December 16, 2013) - La Jolla Pharmaceutical Company (OTCBB: LJPC) (the "Company" or "La Jolla"), a leader in the development of therapeutics targeting significant unmet life-threatening diseases, today announced that it has completed enrollment of its placebo-controlled, randomized Phase 2 clinical trial of GCS-100 in patients with chronic kidney disease ("CKD"). A total of 121 patients with Stage 3b or 4 CKD were enrolled in the study. The Company expects to announce data on the primary endpoint in April 2014 and the full data package before the end of the second quarter 2014.

"We would like to gratefully thank the patients and Investigators for their participation in our Phase 2 study, and we look forward to analyzing the data," said George F. Tidmarsh, M.D., Ph.D., President and CEO of La Jolla. "We plan to make all data available to the public as soon as possible."

This Phase 2 study was designed to enroll approximately 117 subjects, at least 18 years of age, with Stage 3b or 4 CKD. Subjects were randomly assigned 1:1:1 to treatment with placebo, 1.5 or 30 mg/m2 of GCS-100. In addition, randomization was stratified by baseline renal function, defined by eGFR values of 15-29 and 30-44 mL/min/1.73m2. Once randomized, subjects receive eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.

The primary objective of this study is to compare the change in eGFR from baseline to the end of treatment between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for 8 weeks relative to placebo. In addition, the study measures the effect of GCS-100 on circulating galectin-3 and other markers of disease activity.

About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics for chronic organ failure and cancer. GCS-100, the Company's lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. LJPC-501, the Company's second product candidate, is a natural peptide for the treatment of hepatorenal syndrome. For more information on the Company please visit http://www.ljpc.com.

Forward Looking Statement Safe Harbor
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), all of which are available free of charge on the SEC's web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the development of GCS-100 and LJPC-501, the success and timing of future preclinical and clinical studies of these compounds, and potential indications for which GCS-100 and LJPC-501 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.


Company Contact

George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264
Email: GTidmarsh@ljpc.com

and

Chester S. Zygmont, III
Director of Finance
La Jolla Pharmaceutical Company
Phone: (858) 207-4262
Email: czygmont@ljpc.com



Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES