NEWS RELEASE

For Immediate Release

Contact:

William J. Wechter
Chairman and CSO
Tel: (909) 559-4903
FAX: (909) 796-0290
Email:
wwechter@encorepharma.com

 

Encore Reports On Clinical Development Progress with Their Lead Drug Candidate E-7869

 

Encore Pharmaceuticals, Inc., Loma Linda, California; April 17, 2000

 

Encore Pharmaceuticals Inc. (EPI), a start-up company, focused on anti-neoplastic pharmaceuticals, reports clinical progress with E-7869 (R-flurbiprofen) its lead investigational agent for treatment of prostate and colon cancer.

At the March meeting of ASCPT, Encore reported results from a completed Phase I trial (Clin. Pharma. Therap. 67; 103; 2000). The study in normal subjects showed E-7869 to have an extraordinary safety profile with none of the gastrointestinal toxicities that are associated with the aryl propionic acid class of drugs. The study also showed the drug to have an excellent pharmacokinetic profile in men and women given single oral doses up to 2 grams. Contrary to findings in animals, the compound was found to be enantiomerically stable at high doses. Prior to this definitive study, the enantiomeric stability of E-7869 at high doses had been a safety question since the S-enantiomer is a known source of gastrointestinal toxicity in this class of drug. These findings will allow a rapid preclinical and pharmacokinetically-guided clinical development for multiple cancer treatment indications.

Findings from a second study were reported in part at the AACR meeting in San Francisco on April 4, 2000. In an ongoing, multiple dose, safety and tolerance study of E-7869 in hormone refractory prostate cancer patients with disease progression (rising PSA levels), the drug continues to show an excellent safety profile. This is the case when the drug is given as either a once or twice daily oral dose regimen. In this trial, some patients have received daily oral doses of E-7869 for up to 32 weeks. The study is a pharmacokinetically-guided trial. It is designed to evaluate the effect of various E-7869 dose levels and regimens on plasma drug levels and to monitor any emerging bioinversion to S-flurbiprofen which could lead to gastrointestinal intolerance. Biochemical progression is also being monitored in these patients as well as pharmacodynamic measures relevant to the drugs mechanism of action. Recent experimental evidence indicates the mechanism of action for the anti neoplastic effects of E-7869 is related to an effect on the activation pathway of the transcription factor NFkB through a novel undisclosed molecular target.

Encore Pharmaceuticals is currently in active discussions with multiple US and European based pharmaceutical companies to partner the development and commercialization of E-7869.

 

 

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