Investigators are halting recruitment for a small study using T cells reengineered with chimeric antigen receptors against CD19-positive B cells for aggressive non-Hodgkin lymphoma, triggering concerns about the potential fallout at Juno Therapeutics, the biotech formed to commercialize the effort.
Amgen's cancer-fighting viral vaccine has been rolling through Phase III, producing a series of positive results. But after missing a secondary endpoint in overall survival, the California-based biotech's hot prospect now has a big blot on its resume.
Just days after announcing that investigators had red-flagged a high-profile Phase III study of the cancer vaccine MAGE-A3 after failing to hit two primary endpoints for non-small cell lung cancer, GlaxoSmithKline has decided to bring a last-stab effort to find a subpopulation of patients who could benefit from the therapy to a halt. GSK says it was not possible to find a genetically defined group of patients who responded.
Results from a clinical trial of 59 patients with chronic ischemic heart disease and severe heart failure found that a new stem cell treatment improved heart pump function compared to the placebo group.
No matter how badly a drug fails in Phase III, investigators and the companies that employ them often bend over backward to highlight any positive sign of efficacy, no matter how weak the signal. And GlaxoSmithKline's team at the American College of Cardiology meeting over the weekend was in full spin mode with their heart drug darapladib.
Parexel is stretching its global network of clinical trial supply operations with a new distribution center in Singapore, bringing the facility online to better support studies across the globe.
J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J as well as Alkermes, which provided their NanoCrystal delivery tech for the new-and-improved therapy.
A week after the FDA put a halt to Geron's in-house studies of the cancer drug imetelstat over toxicity concerns, the agency stepped in on a Mayo Clinic-run trial of the same treatment, citing familiar dangers and imposing a partial clinical hold.
Once a top Phase III program at the pharma giant, MAGE-A3 failed to hit a pair of primary endpoints for non-small cell lung cancer, its second failure since the melanoma flop that occurred in the first hurdle of the study reported last fall.
If you take some time with Bionomics' release on the Phase II study of their lead cancer drug you'll see that the trial failed, with progression-free survival for a combo use of the therapy with Afinitor tracking closely to the same PFS rate for renal cancer as a control arm which was treated with Afinitor only. The investment community apparently managed to accomplish the heavy lifting, though, pushing shares for the Australian penny stock company down 30% after the data drop.