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CrystalGenomics Announces Positive Phase IIa Results for Osteoarthritis Study of CG100649


12/18/2008 7:05:56 AM

First-in-class NSAID with 'tissue-specific' activity

EMERYVILLE, Calif., Dec. 18 /PRNewswire/ -- CrystalGenomics, Inc. (Seoul, Korea) and CG Pharmaceuticals, Inc. (Emeryville, CA) announced positive results today from a Phase IIa osteoarthritis (OA) study of the efficacy and safety of a next-generation NSAID, CG100649. The CG100649 treatment group met the primary efficacy endpoint by demonstrating a clinically and statistically significant change in the WOMAC(TM) OA score from baseline to Day 21 (p=0.010) compared to placebo. The study also met all key secondary endpoints, with the high dose demonstrating clinically and statistically significant superiority in the WOMAC(TM) OA score over the entire 21-day active treatment period (p=0.009) and in the WOMAC(TM) subscales of pain, stiffness and physical function (p=0.016, p=0.023, p=0.010, respectively) over the entire 35-day treatment and follow-up evaluation periods. Weekly pain relief scores showed statistically significant improvements at Days 7, 14, 21, and 28 (p<0.05 at all time periods) which demonstrated that CG100649 had an early onset of activity and provided sustained treatment benefits over the entire treatment period.

On the primary endpoint of change in the WOMAC(TM) score from baseline to Day 21, the high dose of CG100649 showed more than a 2-fold greater magnitude of improvement than the placebo group (median values were 37% vs. 17%, respectively).

CG100649 is a first-in-class NSAID drug candidate with a new mode of "tissue-specific" activity which is designed to deliver sustained levels of drug to inflamed tissues while maintaining low systemic exposure by binding to carbonic anhydrase (CA) in red blood cells. Its unique dual COX-2 and CA binding properties are designed to provide greater safety to cardiovascular, renal, and gastrointestinal tissues than approved COX-1 or COX-2 inhibitor drugs. The CAs are highly expressed constitutively in vascular, kidney, and gastrointestinal tissues as well as in red blood cells. Previous Phase I single and multi-dose data showed that red blood cells act as a reservoir for CG100649 by carrying large amounts of the drug in a protected and inactive state until it reaches tissues with low CA activity. CAs are not highly expressed in inflamed knee or hip joints which allows CG100649 to dissociate and inhibit COX-2 enzymes. This makes osteoarthritis an ideal target for this tissue-specific compound.

The CrystalGenomics' phase IIa clinical study was conducted in 25 clinical centers located in Germany, Hungary, and Ukraine. Clinical trial CG100649-2-01 was a randomized, double-blind study with 248 subjects that was designed to evaluate the safety and efficacy of three parallel dose regimens of CG100649 to placebo in the treatment of OA. After a 5-14 day washout period from other pain relief medications, all doses were administered orally, once a day in the morning. Subjects returned to the study center once a week on Days 7, 14, and 21 during the treatment period and on Days 28 and 35 during the follow-up period for safety and efficacy assessments.

"We are excited about the strong efficacy and superior safety results from this study, and look forward to further demonstration of CG100649's unique tissue-specific mode of action. Based on these results, we are confident that CG100649 can fulfill the current unmet medical need for an efficacious analgesic and anti-inflammatory agent with potential cardiovascular, renal, and gastrointestinal safety advantages over currently available treatments," commented Dr. Joong Myung Cho, President & CEO of CrystalGenomics.

Positive efficacy results in comparison to placebo

The CG100649 high dose was shown to be superior to placebo on the primary and secondary efficacy endpoints measured in sum of the WOMAC OA index, and its subscales of pain, stiffness, and physical function. Additional measures of weekly pain relief scores and the global assessment by subject and physician showed improvements in OA pain control, with all of these parameters being statistically significant (p<0.05) compared to placebo. These primary and secondary endpoints are confirmed by well-established guidelines in demonstrating the efficacy of new drugs for the treatment of the signs and symptoms of osteoarthritis.

CG100649's beneficial results were also demonstrated on secondary endpoints using the well-established Brief Pain Inventory (BPI). Both the medium and high doses of CG100649 showed clinically and statistically significant improvement in average and worst daily pain intensity (DPI) scores over the entire 21-day active treatment period compared to final 3 days of washout period. In addition to the improvement of WOMAC and DPI scores, overall quality of life was improved in the high dose treatment group compared to placebo group, as shown in indices such as improved sleep, morning stiffness, walking ability, relationships to others, etc.

Early onset and sustained efficacy

The high dose group's clinically and statistically significant effects on the WOMAC OA index and on weekly pain relief scores were apparent from the first time point assessed (Day 7) and continued after the treatment had ended. The sustained efficacy results are consistent with the pharmacokinetic profile of CG100649 established from earlier Phase I studies. The results support CG100649's favorable efficacy profile and suggest a potential compliance advantage with the prospect that missing a daily dose of medication will have minimal effect on steady-state drug levels in target tissues.

No safety concerns

There were no safety concerns relating to CG100649 treatment throughout the study. There were no drug-related serious adverse events (SAEs). All similar minor adverse events (AEs) were observed evenly among the active treatment and placebo groups. As expected from the high gastrointestinal (GI) safety margin observed in preclinical toxicology studies, few subjects reported any GI-related adverse events and there were no differences among any of the active treatment groups and placebo. 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. In particular, there were no increases in systolic or diastolic blood pressure in either younger or older osteoarthritis patients.

Notes:

About CrystalGenomics

CrystalGenomics is a leading structure-based drug discovery and development company headquartered in Seoul, Korea with a US presence (CG Pharmaceuticals, Inc) in Emeryville, California. The company has a diverse pipeline in the disease areas of cancer, inflammation and anti-infectives and two other pre-clinical candidates of a novel antibiotics for MRSA and VRSA, CG400549 and an oral/IV HDAC inhibitor for cancer, CG200745. The Company has established several drug discovery collaborations with leading pharmas and VC groups, including Daiichi-Sankyo, SBI-Biotech, Carna Biosciences, Yuyu Pharma, AmorePacific, Hanmi Pharmaceuticals and ProQuest Investments. CrystalGenomics is publicly-held with a listing on the KOSDAQ exchange (Seoul, Korea).

For further information on CrystalGenomics, please visit the Company's websites at www.cgxinc.com/ and www.cgpharma.com.

Forward-Looking Statements

This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular statements related to the research and development of CG100649 and other compounds. Such statements reflect the current views of CrystalGenomics management and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. There can be no assurance that such development efforts will succeed, that the products will receive required regulatory clearance or, even if such regulatory clearance is received, that the subsequent products will ultimately achieve commercial success. Further, any forward-looking statements contained in this announcement speak only as of the date hereof, and CrystalGenomics expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Paul Kim of CrystalGenomics|CG Pharmaceuticals, +1-510-594-8202,
paulk@cgpharma.com

Web site: http://www.cgpharma.com/
http://www.cgxinc.com//



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