Clinical Data

16 patients have been enrolled in the first four dose cohorts in the initial phase of the trial, receiving a 100 mg, 200 mg, 400 mg or 600 mg oral dose of CPI-818 two times per day, with no dose limiting toxicities and no grade 3 or 4 treatment related adverse events observed.

The median patient follow-up period is now three months, with 11 patients remaining on therapy. One patient with CTCL treated with the 200 mg dose of CPI-818 achieved a reduction in lymphadenopathy and improvement of PET scan imaging; another patient with CTCL receiving the 400 mg dose has exhibited improvement in cutaneous disease. These patients continue on therapy.

The results from the pharmacokinetic and occupancy studies for the first 12 patients have been in-line with expectations, with increasing target occupancy with higher doses based on available data from the 100 mg, 200 mg, and 400 mg doses. The maximum target occupancy has not yet been achieved in the first three dose cohorts, but the Company continues to anticipate that maximum target occupancy will be achieved in the 600 mg cohort, which was recently initiated.