Here are some amendments to the GvHD trial as spel
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Posted On: 02/02/2019 10:26:55 PM
Here are some amendments to the GvHD trial as spelled out in the latest 10q. RP touched on some changes in the latest conference, having everyone on the same treatment plan, so they can easier compare results. I really like his method of meeting the experts and coming up with a better game plan, it made me feel we are in good hands here with the future trial designs. Also the slide deck gave as a milestone interim results 2H2019. The total cost of $4M is relatively inexpensive versus mono trial spread out over the trial length of one year, with first primary endpoint measured after 200 days, 100 days of treatment+100 day wait. I see the added value with good results vs low cost, giving a high return to shareholders.
Phase 2 Trial for Graft-versus-Host Disease
This Phase 2 multi-center100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab (PRO 140) as an add-on therapy to standard graft-versus-host disease (“GvHD”) prophylaxis treatment for prevention of acute GvHD in adult patients with acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) undergoing allogeneic hematopoietic stem cell transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, the Company announced that the FDA had granted orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, the Company filed amendments to the protocol with the FDA. The amendments included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning (“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive leronlimab (PRO 140). The amendments also provide for a 100% increase in the dose of leronlimab (PRO 140), to 700 mg, to more closely mimic preclinical dosing. The next review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Management estimates the cost of this trial to be approximately $3.5 to $4 million.
Phase 2 Trial for Graft-versus-Host Disease
This Phase 2 multi-center100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab (PRO 140) as an add-on therapy to standard graft-versus-host disease (“GvHD”) prophylaxis treatment for prevention of acute GvHD in adult patients with acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) undergoing allogeneic hematopoietic stem cell transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, the Company announced that the FDA had granted orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, the Company filed amendments to the protocol with the FDA. The amendments included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning (“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive leronlimab (PRO 140). The amendments also provide for a 100% increase in the dose of leronlimab (PRO 140), to 700 mg, to more closely mimic preclinical dosing. The next review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Management estimates the cost of this trial to be approximately $3.5 to $4 million.
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