Emergent BioSolutions Inc., of Rockville, Md., said it started a Phase II study of TRU-016 in combination with bendamustine in patients with relapsed chronic lymphocytic leukemia, triggering a $6 million milestone payment to Emergent by Abbott, of Abbot Park, Ill. The study is designed to compare the combination of the anti-DC37 monospecific protein therapeutic plus bendamustine to bendamustine alone in about 100 randomized patients, with a primary endpoint of overall response rate defined by
and one outside – and will enroll previously untreated follicular lymphoma patients, with the primary objectives of complete response rate and progression-free survival...Secondary objectives will include event-free survival, overall survival, overall response rate, health-related quality of life and safety
The primary efficacy endpoint for the trial is intra-cranial response rate...secondary endpoints include progression-free survival and objective tumor response rates
Clinical response rates of 93 percent, 96 percent and 88 percent for the 100 U/kg, 50 U/kg and 2100 U Rhucin doses, respectively, were observed compared with 41 percent in the placebo group
The study also showed trends in favor of TTF compared to chemotherapy in PFS6 (21.4 percent vs. 15.2 percent, respectively, p = ns) and radiological response rates (14 percent vs. 9.6 percent, respectively, p = ns
The study's primary objective is to determine the antitumor effects of Imprime PGG, an immunomodulatory drug, when used in combination with a monoclonal antibody and standard chemotherapy, based on overall response rate as assessed by RECIST criteria
Ltd., of Seoul, South Korea, said interim data from its Phase II trial in Stage III non-small-cell lung cancer (NSCLC) patients vaccinated with the telomerase peptide GV1001 after chemoradiotherapy demonstrated an 80 percent immune response rate
In a previous Phase Ib trial, once-daily oral IPI-926 and gemcitabine generated a response rate of 31 percent, compared to a historic overall response rate of less than 10 percent for gemcitabine
The primary objective is to determine the hematologic improvement-erythroid response rate, as determined by clinically significant transfusion reduction or independence
Pevion Biotech AG, of Bern, Switzerland, reported the latest results from its ongoing clinical study of volunteers vaccinated with the intramuscular high dose of Candida vaccine PEV7, showing high levels of specific antibodies and a 100 percent mucosal immune response rate
Celgene International Sarl, of Boudry, Switzerland, said results from a Phase II study in previously untreated advanced pancreatic cancer showed that Abraxane (paclitaxel albumin-bound particles for injectable suspension) in combination with gemcitabine produced a response rate in nearly half of the patients (21/44, 48 percent...The study's primary endpoint is objective response rate, while secondary endpoints include progression-free survival, duration of response, overall survival and safety
GeoVax also reported the unblinding of data for neutralizing antibody responses in part of the study, which showed elicitation of unexpectedly high response rates of neutralizing antibody for tier 2 isolates of HIV-1
The study found that Telintra, a GST P1-1 inhibitor, produced a 63 percent (12/19) hematologic improvement-erythroid response rate in a group of 19 patients who were transfusion-dependent and Dacogen and Vidaza naïve
Results showed that, in 43 evaluable patients, there were two complete responses, 10 partial responses and 17 patients with disease stabilization, for an estimated overall response rate of 30.8 percent and a clinical benefit rate of 74.4 percent
Emergent BioSolutions Inc., of Rockville, Md., said it started a Phase II study of TRU-016 in combination with bendamustine in patients with relapsed chronic lymphocytic leukemia, triggering a $6 million milestone payment to Emergent by Abbott, of Abbot Park, Ill. The study is designed to compare the combination of the anti-DC37 monospecific protein therapeutic plus bendamustine to bendamustine alone in about 100 randomized patients, with a primary endpoint of overall response rate defined by