Eximias Pharmaceutical Corporation announced that 223 patients have been enrolled into its ETHECC (Efficacy of Thymitaq in Hepatocellular Carcinoma) trial, achieving 50% recruitment. The ETHECC trial is a randomized, Phase III study comparing the survival benefit of Thymitaq versus doxorubicin in patients with unresectable hepatocellular carcinoma (HCC). Patients from North America, the European Union, and South Africa have been recruited into the ETHECC trial, which was designed to confirm the results of three completed Phase II trials and to demonstrate a clear survival benefit in Thymitaq-treated patients with HCC.
“This is a very significant milestone for the only Phase III trial in the United States and rest of world that involves a new compound aiming to provide a survival benefit for HCC patients,” said Dr. García-Vargas, VP of Oncology Clinical Development at Eximias. “We are well on track to complete the ETHECC trial next year and hopefully add a significant treatment to the armamentarium in the fight against cancer,” added Dr. Elizabeth Corsi, President and Chief Executive Officer. Dr. Salomon Hamburg (North America), Dr. Camilo Porta (Europe), and Dr. Paul Ruff (South Africa), the principal investigators of the ETHECC trial, also expressed their satisfaction with achieving this current milestone.
Thymitaq is a potent and direct inhibitor of the enzyme thymidylate synthase (TS), and unlike most other TS inhibitors, binds to both folate sites of TS. The drug is the only non-polyglutamated, lipophilic, direct TS inhibitor in development. Because the drug is lipophilic, Thymitaq does not require the reduced folate carrier (RFC) to enter the cell. Since the drug does not have a glutamate moiety and is not polyglutamated, its activity is therefore not dependent upon folyl polyglutamyl synthase (FPGS) levels for activity. The FDA has granted Thymitaq orphan status and “Fast Track” designation. The NDA is expected to be submitted to the FDA in 2004 and a priority review is anticipated.
Eximias is a specialty pharmaceutical company that acquires, develops, and markets unique pharmaceutical products for oncology and acute care markets. The company has two novel late stage products, and intends to acquire additional products that will generate near term revenues and establish a commercial infrastructure.