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Re: None

Thursday, 09/07/2023 5:21:03 PM

Thursday, September 07, 2023 5:21:03 PM

Post# of 43375
The CMML trial design:

Primary endpoint with 7 secondary endpoints.

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

Trial data needs to be updated. We know that we had 17 active participants as of June 9th.

"Response: The study currently has 17 active participants, ten of which were evaluable on June 9, 2023 when the EHA poster was presented...

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."

https://medicalresearch.com/cancer-_-oncology/preach-m-trial-humanigen-study-evaluates-lenzilumab-and-azacitidine-for-cmml/

In addition, we have the on-going RATinG study for, "... patients who have undergone allogeneic hematopoietic stem cell transplantation and been diagnosed with high-risk aGvHD. The trial will be conducted at up to 22 sites across the UK transplant network in two stages. The first stage of the study will treat 20 patients with lenzilumab before halting for an interim assessment of safety, efficacy, and futility. If an independent data monitoring committee deem the second stage to be feasible, then the trial will progress... " It is this recommendation I am eagerly anticipating.

https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Clinical-Trial-Collaboration-to-Evaluate-Lenzilumab-in-Acute-Graft-Versus-Host-Disease/default.aspx
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