$GALE: Galena Biopharma presents combined safety d
Post# of 23069
Posted On: 06/13/2016 9:08:03 AM
$GALE: Galena Biopharma presents combined safety data from its GALE-401 clinical trials at EHA Congress; results demonstrated that GALE-401 is well tolerated in MPN patients as well as in healthy volunteers
The poster, entitled, "Anagrelide Controlled Release (GALE-401) Safety Profile Consistently Well Tolerated in Myeloproliferative Neoplasms Patients and Healthy Volunteers" was designed to characterize the safety profile of GALE-401 in all subjects treated to date.
In the Phase 2 study, fewer moderate to severe (Grade 3/4) adverse events and fewer AEs per patient (2.3 vs. 3.3) were observed with GALE-401 compared to what has been reported previously with the IR formulation.Additionally, for a small subset of subjects treated in the Phase 2 study who were intolerant to anagrelide IR (n=5), GALE-401 appears to offer a longer duration on therapy compared to previous administration of anagrelide IR. Therefore, a randomized trial comparing GALE-401 vs. anagrelide IR in anagrelide nave subjects, alternatively or together with a trial evaluating anagrelide IR intolerant subjects is warranted. Co states, "Overall, in our Phase 2 study, we observed predominantly mild to moderate toxicities that did not reveal any unexpected AEs, and we are encouraged by the results as it relates to patients who were previously intolerant to anagrelide IR who were able to continue their treatment with GALE-401 for a meaningful longer duration. Given this data, we plan to meet with the FDA later this year to discuss the next stages of development for the asset."
The poster, entitled, "Anagrelide Controlled Release (GALE-401) Safety Profile Consistently Well Tolerated in Myeloproliferative Neoplasms Patients and Healthy Volunteers" was designed to characterize the safety profile of GALE-401 in all subjects treated to date.
In the Phase 2 study, fewer moderate to severe (Grade 3/4) adverse events and fewer AEs per patient (2.3 vs. 3.3) were observed with GALE-401 compared to what has been reported previously with the IR formulation.Additionally, for a small subset of subjects treated in the Phase 2 study who were intolerant to anagrelide IR (n=5), GALE-401 appears to offer a longer duration on therapy compared to previous administration of anagrelide IR. Therefore, a randomized trial comparing GALE-401 vs. anagrelide IR in anagrelide nave subjects, alternatively or together with a trial evaluating anagrelide IR intolerant subjects is warranted. Co states, "Overall, in our Phase 2 study, we observed predominantly mild to moderate toxicities that did not reveal any unexpected AEs, and we are encouraged by the results as it relates to patients who were previously intolerant to anagrelide IR who were able to continue their treatment with GALE-401 for a meaningful longer duration. Given this data, we plan to meet with the FDA later this year to discuss the next stages of development for the asset."
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