Cases of Ebola virus infection in the Democratic Republic of Congo have reached 319, with 198 people dead, making it the largest outbreak in the country's history. "The risk of the outbreak spreading to other provinces in the Democratic Republic of the Congo, as well as to neighboring countries, remains very high," the World Health Organization said.
An international panel of medical and academic experts identified a range of priority issues related to toxicity assessment in clinical trials of treatments for hematologic conditions and defined potential solutions. The commission included toxicities unique to hematopoietic stem cell transplantation among the issues, and the recommendations were reported in The Lancet Haematology.
Sangamo Therapeutics will not be submitting an abstract for presentation at the American Society of Hematology's meeting next month for SB-525, a gene therapy candidate for hemophilia A. An additional dose escalation will be carried out in a Phase I/II study before the data are released.
Maternal use of hormonal contraception during or just before pregnancy was associated with a slightly elevated risk of non-lymphoid leukemia in children, according to a Danish population-based study in The Lancet Oncology. The overall risk remained low, researchers said.
Researchers found that development of graft-versus-host disease was associated with reductions in reservoirs of latent HIV, based on an analysis of data from six men with HIV who received hematopoietic stem cell transplants for the treatment of hematologic conditions. Five of the six had undetectable proviral HIV DNA in blood and tissue and undetectable replication-competent virus after transplant, and of those men, four had developed GVHD. "We believe this reactivity [between donor cells and host cells] might eventually help to sweep away any leftover infected cell[s] from the recipient that might still be circulating in the body, thus contributing to the clearance of the viral reservoir," said Javier Martinez-Picado, an author of the study in Annals of Internal Medicine.
BeiGene's BTK inhibitor candidate zanubrutinib will be evaluated in comparison to AbbVie's Imbruvica, or ibrutinib, in a head-to-head late-stage study in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. Overall response rate will be the primary endpoint in the international trial.
Sorrento Therapeutics has announced positive findings from its Phase Ib trial assessing its chimeric antigen receptor T-cell therapy candidate indicated for patients with carcinoembryonic antigen-positive unresectable metastatic adenocarcinoma with liver metastases. Sorrento will present the data at the Society for Immunotherapy of Cancer annual meeting this week.
A study indicated similar efficacy profiles for daclatasvir plus sofosbuvir plus ribavirin and velpatasvir/sofosbuvir plus ribavirin in patients with hepatitis C virus genotypes 2 and 3. The study appears in the Journal of Hepatology.
Bristol-Myers Squibb's Empliciti, or elotuzumab, in combination with Celgene's Pomalyst, or pomalidomide, and dexamethasone, was approved by the FDA under priority review to treat adult patients with multiple myeloma who have received two or more prior lines of treatment.
Rocket Pharmaceuticals announced that its investigational new drug application for its gene therapy candidate RP-L102, indicated for the treatment of Fanconi anemia, has been approved by the FDA. The study is scheduled to launch next quarter, and Rocket will collaborate with regulatory authorities in the second half of 2019 on a registration process.