Aeras and Emergent BioSolutions advance TB vaccine to phase II trials
Rockville-based biotechs Aeras andEmergent BioSolutions Inc.
, along with their clinical partners, are beginning a phase 2b clinical trial of a tuberculosis vaccine, the first such trial for people infected with HIV.
, along with their clinical partners, are beginning a phase 2b clinical trial of a tuberculosis vaccine, the first such trial for people infected with HIV.Tuberculosis is a leading cause of death among those suffering from HIV.
This trial will be conducted at research sites in Senegal and South Africa and will use the investigational vaccine known as MVA85A, which is being developed by OETC — a joint venture between the University of Oxford and Emergent BioSolutions (NYSE: EBS) — and Aeras, a nonprofit drug developer.
The trial will test the vaccine candidate in approximately 1,400 adults, ages 18 to 50, who are infected with HIV. The study will be led by the U.K. Medical Research Council in The Gambia, Aeras and the University of Oxford. The study wil be conducted at two sites by the University of Cape Town Institute of Infectious Disease and Molecular Medicine in Khayelitsha, South Africa and Laboratoire de Bacteriologie-Virologie du Centre Hospitalier Universitaire Aristide Le Dantec in Dakar, Senegal.
The successful genetic engineering of cancer-attacking cells have created a buzz that a cure may be in the near future.
In the clinical trial conducted by researchers at the University of Pennsylvania, a single genetically designed T-cell -- a type of white blood cell -- was able to destroy 1,000 cancer cells, multiple itself by 1,000 times and survive for months, reported the Los Angeles Times.
Two out of the three patients who participated in the study have been cancer-free for more than a year whereas the third patient still has some cancer cells, but shows signs of improvement.
All three participants suffered from chronic lymphocytic leukemia, a type of cancer of the blood and bone marrow.
To produce T-cells, researchers injected a virus into blood samples before infusing it back into the body. The genetically altered molecule would "instruct" T-cells to attach and attack cancer cells.
"We knew [the therapy] could be very potent," said Dr. David Porter, director of the blood and marrow transplantation program at the Hospital of the University of Pennsylvania in Philadelphia and a coauthor of both papers, which were published in the New England Journal of Medicine and Science Translational Medicine. "But I don't think we expected it to be this dramatic on this go-around."
"This is a huge accomplishment — huge," said Dr. Lee M. Nadler, dean for clinical and translational research at Harvard Medical School, who discovered the molecule on cancer cells that the Pennsylvania team's engineered T cells target.
The findings may be used as a treatment for a range of cancers, including blood, breast and colon.
Currently, bone marrow transplants are the sole type of treatment for eliminating cancer, but procedures are risky and one-fifth of patients typically die of complications.
Result from the study were published in the "New England Journal of Medicine" and "Science Translational Medicine."
