Navigation Links
CrystalGenomics Initiates CG100649 Phase 2b Study in Patients with Osteoarthritis
Date:5/31/2011

SEOUL, South Korea, May 31, 2011 /PRNewswire/ -- CrystalGenomics, Inc. (Seoul, Korea) and CG Pharmaceuticals, Inc. (Emeryville, California), a biopharmaceutical company with 3 clinical stage candidates, has announced that the first patient has been enrolled for a Phase 2b clinical study of CG100649, CrystalGenomics' clinical stage novel NSAID candidate, in patients with knee or hip osteoarthritis (OA).

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 carbonic anhydrase 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.

An earlier placebo-controlled Phase 2a efficacy study in hip and knee in 248 OA patients in Europe showed that a 1.2 mg daily dose provided a highly significant efficacy profile vs. the three major OA symptoms of pain, stiffness, and physical disability.  Although this was not an active-comparator trial, the efficacy profile of CG100649 appeared to be at least as favorable as other COX-2 drugs. This prompted CrystalGenomics to conduct a supra-threshold Phase 1 Multiple Ascending Dose (MAD) study in healthy subjects last year that showed that higher doses of CG100649 (2, 4, or 8 mg per day) are likely to provide even higher levels of efficacy while maintaining CG100649's favorable safety profile.

The current Phase 2b study is a double-blind, randomized, multicenter, non-inferiority, repeat dose study of CG100649 versus celecoxib (Celebrex®) in OA patients. This is the first time that the OA efficacy of CG100649 is being tested directly against celecoxib in the same clinical trial. Considering that CG100649 had already shown a high level of efficacy at 1.2 mg per day in its Phase 2a OA study, it is anticipated that doses of 2 mg/day and 4 mg/day in the Phase 2b study should demonstrate that CG100649 is at least comparable (non-inferior) to celecoxib in terms of efficacy. If the initial hypothesis is supported, additional tests will evaluate whether CG100649 produces superior efficacy compared to celecoxib.  Biomarker results from two previous clinical pharmacology studies in healthy volunteers suggest that CG100649 may produce efficacy results that are superior to celecoxib in this Phase 2b study.

In this Phase 2b study, only subjects recording average pain scores of 4 to 8 on a 0-10 numerical rating scale will be randomized into the study. Study participants will then receive 28 daily doses of either 2 mg/day or 4 mg/day of CG100649, or 200 mg/day of celecoxib. Anti-arthritic efficacy will be evaluated using the standardized Western Ontario and McMaster Universities (WOMAC) OA Index and the WOMAC subscales that measure pain, stiffness, and physical function.

According to Dr. Joong Myung Cho, President & CEO of CrystalGenomics, "This is an important milestone for CrystalGenomics and OA patients worldwide as we will be generating very exciting efficacy data against Celebrex, a multi-billion dollar OA drug that has been one of the pharmaceutical industry's best answers to combat OA symptoms. However, there is still great unmet medical need in this area as Celebrex and other NSAIDs fall short in either efficacy and/or safety in many patients who continue to suffer from the disabling symptoms of knee and hip osteoarthritis. We believe that CG100649 has the potential to provide greater levels of efficacy in osteoarthritis patients while maintaining a high level of cardiovascular and GI safety.  We hope that successful completion of this Phase 2b study will position CG100649 as the leader among the next generation of NSAIDs for treating pain and disability in patients with moderate-severe osteoarthritis."

Celebrex® is a registered trademark of Pfizer, Inc.

Media Contact:
Steven Kim
CrystalGenomics / CG Pharmaceuticals
+82-2-3010-8611
skim@cgxinc.com


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

Related biology technology :

1. Metabolex Initiates Phase 2 Trial of Arhalofenate
2. Isis Initiates Phase 1 Study of ISIS-TTRRx and Earns $5 Million Milestone Payment From GlaxoSmithKline
3. TissueGene Initiates Patient Enrollment for a Phase II Study of TG-C for Osteoarthritis of the Knee
4. Proteon Therapeutics Initiates Patient Enrollment in Phase 2 Clinical Study of PRT-201 in Hemodialysis Patients
5. S*BIO Initiates Phase 2 Clinical Trial of its Novel JAK2 Inhibitor SB1518 in North America for Advanced Lymphoid Malignancies
6. Stephens Initiates Coverage on Vermillion
7. Cell Therapeutics Initiates Pixantrone PIX-R Pivotal Trial for Treatment of Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
8. American Regent Initiates Voluntary Nationwide Recall of Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Single Dose Vials; 5 mL and 30 mL Multiple Dose Vials
9. CalciMedica Initiates Phase I Clinical Trial of First CRAC Channel Inhibitor (CCI) for Psoriasis
10. Max Neeman International Initiates Advisory Committee to Advance and Improve the Conduct of Complex Neurological Trials in India
11. Aperion Biologics Initiates Clinical Trial of Z-Lig™ Device for Anterior Cruciate Ligament Reconstruction
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... , ... AMRI, a global contract research, development and manufacturing ... and quality of life, will now be offering its impurity solutions as a ... requirements for all new drug products, including the finalization of ICH M7 earlier ...
(Date:10/11/2017)... ... October 11, 2017 , ... ... its endogenous context, enabling overexpression experiments and avoiding the use of exogenous expression ... guides is transformative for performing systematic gain-of-function studies. , This complement to ...
(Date:10/11/2017)... (PRWEB) , ... October 11, 2017 , ... ... pathology, announced today it will be hosting a Webinar titled, “Pathology is going ... Pathology Associates , on digital pathology adoption best practices and how Proscia improves ...
(Date:10/11/2017)... Tbilisi, Georgia (PRWEB) , ... October 11, 2017 , ... ... disaster, taking the lives of over 5.5 million people each year. Especially those living ... the greenovative startup Treepex - based in one of the most pollution-affected countries globally ...
Breaking Biology Technology:
(Date:6/30/2017)... 30, 2017 Today, American Trucking Associations ... of face and eye tracking software, became the ... program. "Artificial intelligence and advanced ... monitor a driver,s attentiveness levels while on the ... to detect fatigue and prevent potential accidents, which ...
(Date:5/16/2017)... , May 16, 2017   Bridge ... health organizations, and MD EMR Systems , ... development partner for GE, have established a partnership ... Portal product and the GE Centricity™ products, including ... EMR. These new integrations will ...
(Date:4/17/2017)... , April 17, 2017 NXT-ID, Inc. ... company, announces the filing of its 2016 Annual Report on Form ... Exchange Commission. ... Form 10-K is available in the Investor Relations section of the ... on the SEC,s website at http://www.sec.gov . 2016 ...
Breaking Biology News(10 mins):