Clinical Research

Lilly lung cancer trial misses primary endpoint

Country
United States

Eli Lilly and Company said that a Phase 3 trial (Pointbreak) of a combination treatment for patients with nonsquamous non-small cell lung cancer has failed to meet its primary endpoint of improved overall survival.

Oxford BioMedica moves forward across a broad front

Country
United Kingdom

On the heels of a successful share placement in July, Oxford BioMedica Plc is moving its gene therapy and cancer vaccine programmes ahead with a near-term focus on completing the dosing of patients in a Phase 1 study of a gene therapy for ‘wet’ age-related macular degeneration (AMD).

Lilly stops trials of schizophrenia drug

Country
United States

Eli Lilly and Company has announced a decision to stop Phase 3 development of pomaglumetad methionil for schizophrenia after a futility analysis showed that the second of two studies was unlikely to reach its primary endpoint.

Lilly to discuss solanezumab results with regulators

Country
United States

Eli Lilly and Company is to seek advice from regulators about the possible next step for its investigative Alzheimer’s treatment, solanezumab, following the failure of two Phase 3 trials in patients with mild-to-moderate forms of the disease.

Germany’s Mologen gives clinical update

Country
Germany

Mologen AG of Germany is expediting discussions with potential pharmaceutical company partners with a view towards starting a Phase 3 study of its lead product for colorectal cancer next year. The product, MGN1703, is a toll-like receptor 9 agonist.

Leg ulcers treated with cell-based therapy

Country
United States

A new allogeneic cell therapy has shown promise in the treatment of venous leg ulcers, a condition caused by persistently high blood pressure in the veins of the legs. Results from a 2b study of the therapy were published online in The Lancet on 3 August 2012.

Roche reports on trial with Avastin

Country
Switzerland

Roche said that its angiogenesis inhibitor, Avastin (bevacizumab), has shown a significant improvement in progression-free survival in newly diagnosed glioblastoma when added to radiation and temozolomide. Overall survival data are expected in 2013.

4SC gives update on resminostat

Country
Germany

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 stops ganitumab pancreatic cancer study

Country
United States

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.

AZ discontinues sepsis programme

Country
United Kingdom

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.