NVCR were trading up more than 24 percent in Friday’s after-hours session, after new Phase 3 showed that “glioblastoma patients who received TTFields in combination with chemotherapy at first recurrence lived significantly longer than patients who received chemotherapy alone.”
Bluebird Bio Speakers at CAR-T Summit
Richard Morgan VP, Immunotherapy
Kevin Friedman Associate Director, Immunotherapy
A radical gene therapy to combat HIV using genetically modified cells that are resistant to the virus has been declared a success by scientists following the first clinical trial.
The treatment, which has never been tested on humans before, raised patients' defences against HIV by replacing some of their natural immune cells with GM versions.
Tests on people enrolled in the trial found that the disease-resistant cells multiplied in their bodies.
Half of patients were taken off their usual drugs for three months and scientists recorded reduced levels of the virus.
Scientists were cautious not to draw strong conclusions from the small scale trial, which was designed to assess the safety of the therapy, but the early signs have raised their hopes.
"We are absolutely encouraged by these results," said Bruce Levine, who helped to run the trial with a colleague, Carl June, at the University of Pennsylvania. "This is potentially a new therapy for HIV."
A baby girl with aggressive leukaemia has become the first in the world to be treated with designer immune cells that were genetically engineered to wipe out her cancer.
Maxim Group analyst Jason Kolbert wrote in a research note that even those patients who needed transfusions benefited from the treatment. He added that the mixed result in beta-thalassemia doesn't necessarily translate to sickle cell disease, which creates anemia by a different mechanism.
"In SCD, LentiGlobin has to produce enough beta globin to keep sickled hemoglobin below 30% (done)," Kolbert wrote. "Most beta thalassemia patients need enough beta globin from LentiGlobin to make good hemoglobin levels to eliminate transfusions (done). Patients (beta-zero) that have the most severe disease make good hemoglobin as a result of LentiGlobin but have only had reduction in transfusions, not independence."
3:52 am MiMedx Group comments on the FDA Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products (MDXG) :
The co commented on the proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products that the Food and Drug Administration published for comment on October 28, 2015 and the Notice of Public Hearing and Request for Comments released today indicating the agency would hold a public hearing on April 13, 2016 to obtain input on that Guidance as well as three other recently issued guidance documents on HCT/Ps.
"It is our management's opinion that we are and have been in compliance with the homologous use requirements. We have always marketed our products with general intended uses that have been documented by the FDA as being homologous use for amniotic tissue. Our marketing does not reflect statements about our membranes being intended for use for specific indications such as dermal ulcers. Our materials are much more general, and reflect uses that the FDA has already declared as homologous use for amniotic tissue."
“We are thrilled to have a significant presence at ASTRO’s annual meeting and look forward to introducing Optune for newly diagnosed GBM to this important clinical community,” said Pritesh Shah, Novocure’s US General Manager. “Both Novocure and radiation oncologists treat glioblastoma with a physical modality and we believe there is a natural fit for us to work together to bring Tumor Treating Fields therapy to patients.”
About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).
Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
For the treatment of recurrent GBM, Optune is indicated following histologically-or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
American Society for Radiation Oncology (ASTRO)