Humanigen Inc (HGENQ)

[cowtown jay]

The tenths of a penny that our share price fluctuates is meaningful to you. I get that.

But the daily data that interests me is the following CMML trial data. especially for the Primary Endpoint, and Secondary Endpoints 4, 5, 6, and 7, all of which should have reportable data by now.

"Primary outcome [1] To assess the frequency of complete response (CR) and partial response (PR) at any point during the first 12 cycles of active therapy according to Savona Criteria. (composite outcome)
Timepoint [1] Any point during the first 12 cycles
Secondary outcome [1] Overall survival (as measured by medical records/follow-up.)
Timepoint [1] 2 years from Cycle 1, Day 1
Secondary outcome [2] Progression-free survival (as measured by medical records/follow-up)
Timepoint [2] 2 years from cycle 1, day 1
Secondary outcome [3] The proportion of participants who derive a clinical benefit according to Savona Criteria
Timepoint [3] The proportion of participants who derive a clinical benefit at any point during the 24 cycles of active therapy. This will be evaluated at the conclusion of study.
Secondary outcome [4] Assessment of the impact of treatment on physical capacity by serial assessment of Multidimensional Geriatric Assessment.
Timepoint [4] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal.
Secondary outcome [5] Toxicity evaluation, both haematological and non-haematologic for both arms of the study by assessment of adverse event reporting and test results.

(Composite outcome)

Tests include blood tests and bone marrow tests. Toxicity will also be evaluated by asking participants about their health at every visit.
Timepoint [5] Throughout the 24 cycles of active therapy. (Assessed throughout as serious adverse events reported immediately). Participants will be asked about their health at every visit (baseline, cycle 1 days 1, 2, 4, 7, 15 & 22 and then day 1 of each cycle (maximum of 24 cycles). Blood tests will be collected every visit (baseline, cycle 1 days 1, 2, 4, 7, 15 & 22 and then day 1 of each cycle (maximum of 24 cycles). Bone marrow tests will be collected after 3, 6, 12 & 24 cycles of treatment.
Secondary outcome [6] Assessment of the impact of treatment on functional capacity by serial assessment of Multidimensional Geriatric Assessment.
Timepoint [6] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal.
Secondary outcome [7] Assessment of the impact of treatment on social wellbeing by serial assessment of quality of life questionnaires.
Timepoint [7] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal."

https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380941&isReview=true