4SC AG has been taking scientific advice from regulators about the design of a prospective Phase 3 study of its HDAC inhibitor for liver cancer, resminostat. Pending the conclusion of a partnership, a study could start in the 2013 first half, according to management.
Amgen has stopped a Phase 3 trial of its monoclonal antibody for metastatic pancreatic cancer after the independent data monitoring committee concluded the drug was unlikely to show improved overall survival compared with gemcitabine.
A second experimental treatment for severe sepsis, a significant area of unmet medical need, has been discontinued following the failure of a proof-of-concept trail. AstraZeneca Plc has stopped development of AZD9773, an anti-TNF-alpha antibody fragment.
Agennix AG is set to restructure after the surprise failure of a Phase 3 trial of its lead product for non-small cell lung cancer, talactoferrin alfa (talactoferrin). The trial did not meet its primary endpoint of improving overall survival, despite promising earlier data.
Johnson & Johnson Inc and Pfizer Inc have announced the termination of their jointly-run investigation of the drug, bapineuzumab, for patients with mild-to-moderate Alzheimer’s disease. This follows the failure of two Phase 3 studies.
The US Food and Drug Administration has lifted a clinical hold – imposed in 2007 – on an allergy vaccine trial that was being conducted by Allergy Therapeutics Plc, paving the way for further testing and commercialisation of the product.
Apogenix GmbH said that a final analysis of data from its Phase 2 proof-of-concept trial of a new drug for glioblastoma, APG101, confirmed the agent’s therapeutic effect as well as its safety and tolerability. The trial recruited 84 patients in 25 centres in Europe.
Pfizer Inc has announced the failure of the first of four studies of a prospective antibody treatment for patients with mild-to-moderate Alzheimer’s disease who carry the ApoE4 genotype. The other three studies are still ongoing.
Sanofi SA and Regeneron Pharmaceuticals Inc have started enrolling patients in a Phase 3 programme that will evaluate the effectiveness of a new antibody in lowering low-density lipoprotein cholesterol. The antibody targets the PCSK9 enzyme.
Convergence Pharmaceuticals Ltd is making plans to advance a second small molecule drug for neuropathic pain into Phase 2 following a successful first-in-man trial. The compound, CNV2197944, is a calcium channel blocker.