Investor Meeting to discuss the data presented at the American Society of Hematology (ASH) Annual Meeting will be held in San Diego, CA on December 3 at 11 pm
Monday, December 3, 2018
Bluebird Bio to hold an analyst and investor event
In conjunction with the American Society of Hematology (ASH) Annual Meeting, Management holds an Analyst and Investor Event in San Diego, CA on December 3 at 11:30 pm.
Seattle Genetics to hold an investor and analyst event
Management discusses the Phase 3 ECHELON-2 Trial, as well as other key data presented at the ASH Annual Meeting, at an Investor and Analyst Event being held in San Diego, CA on December 3 at 11:15 pm.
Celgene announces initial clinical data of JCARH125 in multiple myeloma
Celgene announced initial safety data from its ongoing proof-of-concept trial of JCARH125 in patients with relapsed/refractory multiple myeloma. JCARH125 is an investigational BCMA-targeting CAR T cell therapy being developed by Juno Therapeutics, a Celgene company. Results were presented by Sham Mailankody, MBBS, in an oral presentation at the 60th American Society of Hematology Annual Meeting. The data reported from the multicenter, phase 1/2 EVOLVE trial includes patients who have been treated with JCARH125 in the dose escalation study. The primary objectives of the phase 1 portion of the trial are safety and identification of a recommended phase 2 dose. The patients enrolled in the study had to have received at least three prior lines of multiple myeloma therapy, including an autologous stem cell transplant for transplant eligible patients, a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Dose escalation is currently ongoing. At data cut off, 44 patients have been infused with JCARH125 in three dose escalation cohorts. These patients were heavily pretreated, with a median of seven prior lines of therapies , and 77% had high-risk cytogenetics. Seventy-one percent of patients experienced grade 1 and 2 cytokine release syndrome with 9% of patients experiencing grade 3/4 CRS. In addition, 18% of patients experienced grade 1 and 2 neurological events with 7% of patients experiencing a grade 3/4 event. Other frequent grade 3/4 AEs included neutropenia in 86%, anemia in 50%, thrombocytopenia in 43% and infection in 14%. In this first report of JCARH125 data, the median follow up was only 11 weeks, yet among infused patients, the overall response rate was 82%. At the lowest dose level of 50×106 CAR T cells, the ORR was 79% and 43% of patients achieved stringent complete response or complete response.
https://thefly.com/landingPageNews.php?id=2831625
Allogene, Servier present data from UCART19 phase 1 study
Allogene Therapeutic and Servier announced results from an updated analysis of pooled clinical data from two ongoing Phase 1 studies of UCART19, the first allogeneic CAR T-cell therapy in clinical study, in pediatric and adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The analysis showed that 82% of patients who received a lymphodepletion regimen consisting of fludarabine, cyclophosphamide and an anti-CD52 mAb achieved a complete remission or complete remission with incomplete blood recovery. In the four patients who received fludarabine and cyclophosphamide only, there was minimal UCART19 expansion and no response. Overall, 67% or 14/21 of patients achieved a CR/CRi. These data suggest an anti-CD52 antibody is an important addition to the lymphodepletion regimen for allogeneic CAR T cell expansion. The most common adverse events were related to cytokine release syndrome and were generally manageable.
https://thefly.com/landingPageNews.php?id=2831633
Kite Pharma announces updated Zuma-3 data from KTE-X19 Phase 1/2 study
Kite, a Gilead Company, announced updated results from ZUMA-3, a single-arm Phase 1/2 study evaluating KTE-X19, an investigational CD19 chimeric antigen receptor T cell therapy, in adult patients with relapsed or refractory acute lymphoblastic leukemia. With a median follow-up of 15.1 months following a single infusion of KTE-X19, 69 percent of evaluable patients achieved complete tumor remission, defined as complete remission or CR with incomplete hematological recovery. The rate of undetectable minimal residual disease in patients who achieved complete tumor remission was 100%. Adverse events were consistent with the known toxicities of CD19 CAR T treatment, including Grade 3 or higher cytokine release syndrome and neurologic events in 23% and 39% of patients, respectively. The majority of these adverse events were resolved, with the exception of two patients who had ongoing neurological events at the time of death from other causes. Two patients died from adverse events deemed by the treating investigator to be related to KTE-X19.
https://thefly.com/landingPageNews.php?id=2831635
Benefits of Cannabidiol for Epilepsy Fades in One-Third of Patients
About one-third of patients who used cannabidiol (CBD) to manage treatment-resistant epilepsy developed tolerance to it, researchers from Israel reported here.
In a study of 92 children and young adults with treatment-resistant seizures who used cannabis oil extract for an average of 19.8 months, tolerance to CBD emerged in 32.6% of patients, reported Shimrit Uliel-Sibony, MD, of Tel Aviv Sourasky Medical Center’s Dana Children’s Hospital, and colleagues at the American Epilepsy Society annual meeting.
“CBD is a good option for children and adults with certain kinds of epilepsy, but as with anti-epileptic drugs, it can become less effective over time and the dose may need to be increased to manage the seizures,” Uliel-Sibony said in statement. While previous research has shown that the effectiveness of cannabinoids can decrease when it is used for pain management and in the treatment of animals with seizures, this is the first large study to show it can occur with humans who use CBD to treat epilepsy, she added.
In the U.S., the FDA has approved a purified, pharmaceutical-grade formulation of cannabidiol (Epidiolex), a chemical component of the Cannabis sativa plant, for children with Lennox-Gastaut and Dravet syndromes.
In this prospective study, Uliel-Sibony and colleagues followed patients in Tel Aviv, ages 1-37 years (average age 11.8) from 2014 to 2017 with treatment-resistant epilepsy of various etiologies, ranging from Dravet syndrome and Lennox-Gastaut syndrome to epilepsy caused by stroke. All patients subsequently had been treated with one of two strains of CBD-enriched cannabis oil extract that had a 20:1 CBD-to-tetrahydrocannabinol (THC) ratio.
The researchers defined tolerance as either the necessity to increase dose by ≥30% after efficacy declined, or a response reduction of >30%. They saw tolerance in 30 patients, on an average dose of 12.6 mg/kg/day. The mean time until tolerance appeared was 7.3 months (range 1-24 months).
The researchers increased the CBD dose in most patients who developed tolerance; 12 patients achieved their previous response level and 15 did not.
“By definition, most patients with treatment-resistant epilepsy do not enjoy long-term benefits from a new anti-seizure therapy — that is, a ‘honeymoon effect,'” said Orrin Devinsky, MD, of New York University Langone Health in New York City, who was not involved with the study.
“This study found that tolerance develops in one-third of patients with treatment-resistant epilepsies who showed an initial reduction in seizures to a high CBD/low THC product after 7 months,” Devinsky told MedPage Today. “The observation that two-thirds of patients did benefit over a long follow-up period is a key finding.”
There was no statistically significant correlation between patient’s age and tolerance, but patients with shorter epilepsy duration showed a higher tendency to develop tolerance, Uliel-Sibony’s group noted. Predictive factors and mechanisms are unknown, and long-term studies to better characterize the long-term efficacy and safety of CBD are needed, they added.
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