The Phase 1/2 interim data
include eight patients treated across four ascending dosage cohorts (9e11 vg/kg, 2e12 vg/kg, 1e13 vg/kg and 3e13 vg/kg, with two patients per cohort).
According to the company, this interim data
show a very good efficacy profile for melflufen in combination with either bortezomib or daratumumab.
from the trial, led by Horatio Cingolani, M.D., of the National University of La Plata (Argentina), showed that left ventricular ejection fractions significantly increased from 35% to 38% in the oxypurinol group and decreased from 30% to 29% from baseline in the placebo group.
United States-based Sangamo Therapeutics and Pfizer have revealed interim data
from the Phase 1/2 Alta study assessing investigational SB-525 gene therapy for severe haemophilia A, it was reported yesterday.
from Part 1 of the SUNFISH study in Type 2 and 3 SMA, also presented at WMS 2018, demonstrated a median >2-fold increase in SMN protein levels in the blood following 12 months of treatment.
Global Banking News-December 3, 2018-Oncopeptides announces presentation of first interim data
from the ongoing combination trial ANCHOR at the 60th ASH meeting
"The clinical observations and interim data
of these patients, all of whom received combined intramuscular and intrathecal injections of NurOwn cells, were very impressive and appear to reinforce the positive results from Brainstorm's Phase 1/2 ALS trial," Karussis said.
The interim data
showed a complete remission rate of some 46% in patients who failed to respond to cytarabine-containing first-course treatment, independent of their human equilibrative nucleoside transporter 1 (hENT1) status.
Analysts said it was a very positive development for both Elan and Wyeth, given that the acceleration of the drug into a Phase III study was only going to be considered if the interim data
showed a significant improvement in patient progress.
Based on a statistical method that takes into account when a pregnancy occurs and other factors, interim data
revealed that the device had a six-month failure rate of 12.2 percent, testified Gaston Farr, project manager of the trial and associate director of clinical trials at Family Health International in Research Triangle Park, N.C.
Upon review of the interim data
by the ISDMC, the sponsor decided to suspend recruitment, allow the data to mature and conduct additional sub-group analyses.
M2 PHARMA-April 4, 2019-Sangamo Therapeutics and Pfizer reveal interim data
from haemophilia Phase 1/2 Alta study