Navigation Links
CrystalGenomics Announces Positive Results from Phase 2b Osteoarthritis Study of CG100649
Date:4/18/2012

SEOUL, South Korea, April 18, 2012 /PRNewswire/ -- CrystalGenomics, Inc., a biopharmaceutical company headquartered in Korea, has just announced positive results from the Phase 2b osteoarthritis (OA) study of the CG100649, CrystalGenomics' next-generation NSAID candidate. The study met its primary and secondary endpoints which were to evaluate the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex® (celecoxib) (200 mg per day) over the 4 week treatment period.

This Phase 2b study was a double-blind, randomized, multicenter, non-inferiority, repeat dose study of CG100649 versus Celebrex in OA patients. Following a 5-14 day washout from all prior pain medications except paracetamol (acetaminophen), subjects recording moderate to severe hip or knee OA pain of 4 to 8 on a 0-10 numerical rating scale were randomized into the study. All subjects received 28 daily doses of either CG100649 2 mg or 4 mg, or Celebrex 200 mg. Anti-arthritic efficacy was evaluated using the standardized WOMAC OA Index and the WOMAC subscales of pain, stiffness, and physical function. The primary efficacy outcome was determined by measuring the change in the average WOMAC-Pain subscale in the index joint at Day 28 vs. Baseline. Secondary efficacy outcomes included the change in the WOMAC Pain at Days 7, 14, 21, 35, and 42; changes in the total WOMAC OA Index at Days 14, 28, and 42, changes in the WOMAC Stiffness & Physical Function subscales at Days 14, 28, and 42; and Subject's Global Assessment and Physician's Global Assessment of OA pain at Days 1, 14, 28 and 42. Throughout the study, both of the CG100649 treatment groups demonstrated non-inferiority compared to Celebrex on all primary and secondary outcome measures.

There were no drug-related serious adverse events (SAEs) in either of the CG100649 treatment groups or in the Celebrex treatment group. Similar non-serious adverse events (AEs) were observed in the CG100649 and Celebrex treatment groups. Although a long-term cardiovascular safety profile could not be established by this short-term study, there were no indications that CG100649 had a negative impact on heart function, ECG profiles, or blood pressure.

Dr. William Schmidt, Vice President of Clinical Development, said, "The two higher doses of CG100649 used in this study complete the pre-planned Phase 2 dose-ranging phase for CG100649 and allow us to select a dose for the Phase 3 study that will be initiated later this year."

Dr. Joong Myung Cho, President & CEO of CrystalGenomics, stated, "This is an important milestone for CrystalGenomics and OA patients worldwide as we were successful in generating very exciting safety and efficacy data against Celebrex. The positive results from this Phase 2b study will strengthen CG100649's position of becoming the next generation NSAID for treating pain and other OA symptoms in patients with moderate to severe OA."

About CG100649
CG100649 is a first-in-class NSAID drug candidate that is a dual inhibitor of COX-2 and carbonic anhydrase (CA). CG100649's interaction with CA in red blood cells provides it with a novel 'tissue-specific' transport mechanism that is designed to deliver sustained levels of drug to inflamed tissues, while maintaining low systemic exposure. Its unique dual COX-2 and CA binding properties are designed to provide potentially superior safety to cardiovascular, renal, and gastrointestinal tissues compared to traditional NSAIDs or COX-2 inhibitor drugs.

About CrystalGenomics
CrystalGenomics, Inc. is a clinical stage biopharmaceutical company with drug discovery and development capabilities that is headquartered in Seoul, Korea, with a US presence for multi-national clinical management (CG Pharmaceuticals, Inc.) in Emeryville, California.  CrystalGenomics is publicly traded on the KOSDAQ exchange. CrystalGenomics is dedicated to the discovery and development of novel pharmaceuticals to address high unmet medical needs in areas of infectious disease, cancer, and inflammation. For more information on CrystalGenomics, please visit: www.cgxinc.com.

Celebrex® is a registered trademark of Pfizer, Inc.

Media Contact:
Steven Kim
CrystalGenomics
+82-31-628-2720
skim@cgxinc.com


'/>"/>
SOURCE CrystalGenomics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CrystalGenomics Completes Phase I MAD Study of its Novel Antibiotic Candidate CG400549, and Prepares for Phase II Clinical Study
2. CrystalGenomics Announces Successful Completion of a Phase I SAD Clinical Trial for CG400549, its Novel Antibiotic Candidate
3. Pinnacle Biologics Inc. Announces Appointment of Bioprojet Pharma as Exclusive Distributor in Select European Countries
4. Stemline Therapeutics Announces Two Presentations of Direct Injection Synthetic Peptide Vaccine for Brain Cancer, Now Being Developed as SL-701, at the Annual Meeting of the American Association of Cancer Research (AACR)
5. Akorn, Inc. Announces First Quarter 2012 Earnings Release and Conference Call Information
6. Tengion Announces IND Filing for Neo-Kidney Augment Expected During First Half of 2013
7. ConvaTec Healthcare Announces 2011 Year-end Earnings Call
8. The Galien Foundation Announces Prix Galien USA Awards Committee, Chaired by Dr. P. Roy Vagelos
9. Morphotek®, Inc. Announces Initiation of MORAb-004 Phase 2 Study in Metastatic Colorectal Cancer
10. Sangamo BioSciences Announces Presentation at the Future Leaders in the Biotech Industry Conference
11. Gamma Pharmaceuticals, Inc. Announces Distribution Agreement for New York Tri-state Area and Purchase Order for Gamma Energy GEL™
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... PITTSBURGH , Dec. 5, 2016  Wellbridge Health and ... innovative digital health solutions to Medicare and Medicaid plan members ... effort targeted at the unique needs of this group of ... on social work philosophies to provide insight into members, daily ... , ...
(Date:12/5/2016)... WOONSOCKET, R.I. , Dec. 5, 2016 /PRNewswire/ ... CVS ) Research Institute and the U.S. ... the Assistant Secretary for Preparedness and Response (ASPR), ... showed that automated pharmacy notifications encourage patients ... a forecasted natural disaster. The study also affirms ...
(Date:12/5/2016)... , Dec. 5, 2016  BD (Becton, Dickinson ... global medical technology company, will demonstrate an enhanced technology ... management technologies, including the company,s leading Pyxis™ and Alaris™ ... Pharmacists (ASHP) 2016 Midyear Meeting being held in ... While national data show that approximately 68 ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... December 05, 2016 , ... ... portfolio company, today announced it has acquired the assets of Frankfurt, Germany ... a subsidiary of Chiltern International and focuses on clinical trial drug packaging, ...
(Date:12/5/2016)... ... December 05, 2016 , ... ... physical therapist assistants, under direct supervision of a licensed physical therapist, to render ... receives a consultation and treatment plan from a licensed physical therapist (PT) and ...
(Date:12/5/2016)... ... 2016 , ... As renowned, board-certified dermatologists, Dr. Sabrina G. Fabi and Dr. ... do not do their research and undergo cosmetic dermatology treatments from unqualified practitioners or ... a renaissance and every other month a new treatment or device is launched, promising ...
(Date:12/5/2016)... ... December 05, 2016 , ... Z-Medica, LLC, a leading ... with The American College of Surgeons (ACS) to provide basic bleeding control instructor ... Control Basic” course is a pilot program that fulfills the intent of the ...
(Date:12/4/2016)... ... December 03, 2016 , ... The ... funding innovative lymphoma research and serving the lymphoma community through a comprehensive series ... A Wine Tasting Event in New York City, with long-time partners The Paul ...
Breaking Medicine News(10 mins):