Five out of the six evaluable
patients achieved a confirmed, partial response as defined by standard RECIST criteria for an overall response rate of 83%, including durable responses of more than 18 months in two patients.
Evaluation of the evaluable
criteria by means of formulas
In the trial, patients will receive 18mg of enobosarm once daily for up to 12 months and the initial stage will be assessed among the first 21 evaluable
Of 270 patients who were evaluable
at 4 months, 77% opted to participate in a single-blind 8-month extension of the initial study that included continuation of the lifestyle intervention.
Overall cure rates in the clinically evaluable
population were 93.
During follow-up, LVEF increased by an average of 3% over baseline in 92 evaluable
control patients and by an average of 5.
The ITT group was defined as patients who received at least one dose of study medication and completed at least one study evaluation, while the evaluable
population was the subset of 75 patients (n=50 chromium picolinate and 25 placebo), who took at least 80% of the study product with no significant protocol deviations.
Efficacy -- Data on the debridement of wound eschar (removal of burned tissue) were analyzed from seven evaluable
patients and data on the time to 90 percent epithelialization (the point at which wounds appear to be healing normally) were analyzed from 12 evaluable
As of a data cutoff date of February 1, 2018, 20 evaluable
patients have completed 24 weeks of KD025 treatment, and 9 evaluable
patients in the BSC arm have completed 24 weeks of follow-up.
The open-label, multi-centre, multinational Phase two clinical trial (NCT02463032) will evaluate the efficacy and safety of orally administered enobosarm in up to 88 evaluable
patients with metastatic or locally advanced, ER+/AR+ breast cancer.
The study with Onyvax-P targets a total of 48 evaluable