19 January - At the American Society of Clinical Oncology - Gastro Intestinal conference on 15-17 January 2009 TopoTarget presented positive data from a phase Ib/II study with belinostat and 5-fluorouracil (FU) for patients with colorectal cancer were presented. The study has established that belinostat and 5-FU can be safely given together in full doses. The study also indicates that the treatment can be targeted to a selected group of patients who can benefit from the treatment with belinostat and 5-FU (BelFU).
12 January - Genzyme Corp. and Isis Pharmaceuticals, Inc. announce that they have begun two new studies of mipomersen, a novel lipid-lowering drug in late-stage development, and a third is currently screening patients. These three trials will provide additional data on mipomersen in high-risk patient populations.
8 January - TopoTarget A/S has announced that belinostat can be safely administered at higher doses than previously applied in the standard belinostat day 1-5 schedule. A phase 1 study including patients with previously untreated hepatocellular (liver) cancer being conducted by the Cancer Therapeutic Research Group (CTRG) and sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI, US) has been completed.
6 January - TopoTarget A/S has moved belinostat into the randomized portion of a study in patients with hematologic malignancies where patients with Myelodysplastic Syndrome or Acute Myelogenous Leukaemia will be treated. The study is sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute under a Clinical Trials Agreement with TopoTarget for the development of belinostat.
5 January - Genmab A/S has announced that the interim survival analysis of the Phase III pivotal study investigating zalutumumab (HuMax-EGFr) in refractory head and neck cancer patients did not fulfill a criterion for early stopping after half the trial has been completed. An Independent Data Monitoring Committee (IDMC) has evaluated the interim results and concluded that the benefit-risk profile of zalutumumab is acceptable. The IDMC recommended that the trial should continue to enroll up to a maximum of 273 patients and a final analysis performed.
>> December