Humanigen Inc (fka HGENQ)

[cowtown jay]

It seems to me that we could be approaching the time to begin reporting the Primary Endpoint outcomes from the PREACH-M trial for CMML. The Primary Endpoint, "To assess the frequency of complete response (CR) and partial response (PR)...," could apparently be reported at any point during the first 12 cycles of active therapy.

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

In June, we also had 10 of those patients already meeting certain Secondary Endpoints, such as Overall survival, Progression-free survival, The proportion of participants who derive a clinical benefit, and perhaps more. "All ten evaluable participants had a rapid clinical response."

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Presents-Promising-New-Hematologic-Data-from-PREACH-M-Trial-for-Chronic-Myelomonocytic-Leukemia-Treatment-at-the-2023-Europ-OYZCQ.pdf

Dr, Thomas, the trial investigator, told 'Medscape' "the investigators have been "pleasantly surprised” at how well patients tolerated the monoclonal antibody.

"We haven't had any infusion reactions, we haven't had any pulmonary alveolar proteinosis, we haven't had any fevers from the infusion, from the antibody,” he said."

Each parameter (blood monocytes, bone marrow blast percentage, platelet count, blood hemoglobin concentration, and spleen size) has exhibited a durable return to normal or near normal values, with statistical significance. Two of the ten participants have been in the trial for 18 months, the longest of any participants, and exhibit lasting improvement. No participants have relapsed. One participant is now a candidate for stem cell transplantation, which may lead to a potential cure in that patient." Does this indicate a Complete Response?