Virexxa Technology-Based Candidates

Internal Pipeline

Preclinical Phase 1 Phase 2 Phase 3
Virexxa® Virexxa Endometrial cancer
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
Triple Negative Breast Cancer
Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
  • Indicates programs completed.
  • Indicates programs in progress in such phase.

Our development program for Virexxa (sodium cridanimod) includes an ongoing Phase 2 study under our US IND for Virexxa in conjunction with progestin therapy in a population of subjects with progesterone receptor negative (PR) recurrent or persistent endometrial cancer. This study is also active under the same IND (through Pharmsynthez/Kevelt) in Belarus and Ukraine. It is an open-label, multicenter, single-arm Phase 2 study calling for a total of 58 subjects with documented evidence of PR endometrial cancer as determined by immunohistochemistry.

The primary objective of this study is to assess the anti-tumor activity of Virexxa in conjunction with progestin therapy as measured by objective response rate (partial/complete) in women with progesterone receptor negative recurrent or persistent endometrial carcinoma not amenable to surgical treatment, radiotherapy, or chemotherapy.

Secondary objectives of the study are:

  • to assess progression free survival, time to response, time to progression, duration of overall survival and Overall Disease Control Rate for subjects receiving Virexxa and progestin therapy; and
  • to evaluate the safety and tolerability of Virexxa in conjunction with progestin therapy, as measured by adverse events, laboratory safety parameters, and cardiac safety assessments.

Additional translational objectives include determining the efficacy of Virexxa in combination with progestin on PR levels in tumor tissue, to assess the association of change of PR levels with efficacy variables and to assess pharmacokinetic data for Virexxa and progestins after a single-dose and multiple-dose administration.