Clinical Trials

Date: 2018-01-03

Type of information: Treatment of the first patient

phase: 1

Announcement: treatment of the first patient

Company: Basilea Pharmaceutica (Switzerland) Adult Brain Tumor Consortium (ABTC) (USA)

Product: BAL101553 in combination with standard radiation

Action mechanism:

  • microbutubule inhibitor. BAL101553 is an intravenous and oral microtubule-targeting agent. This highly water-soluble prodrug of the synthetic small molecule BAL27862 allows intravenous and oral administration without solubilizing excipients associated with adverse effects. BAL27862 arrests tumor cell proliferation and induces tumor cell death through a characteristic destabilizing effect on microtubules that is distinct from other anti-cancer agents also directed against the microtubule network. Anti-tumor activity has been demonstrated across a broad panel of solid tumor models, including those resistant against conventional microtubule-targeting drugs such as taxanes or Vinca alkaloids.
  • In addition to the activity in glioblastoma tumor lines, BAL101553 was shown to have potent anticancer activity against glioblastoma stem-like cells in a pre-clinical model as reported in a recent publication co-authored by Basilea and the research group of Prof. Diane Braguer of Aix-Marseille University, France. Tumor stem-like cells contribute to glioblastoma regrowth as well as brain invasion, a phenomenon which also occurs in the pre-clinical model used. The publication further reported the observation that BAL101553 promoted the loss of stem-cell properties. These published data further support the potential of BAL101553 to target glioblastoma, a tumor often associated with poor prognosis for patients.

Disease: newly-diagnosed glioblastoma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

Latest news:

  • • On January 3, 2018, Basilea Pharmaceutica announced the initiation of a phase 1 study conducted under its clinical study agreement with the Adult Brain Tumor Consortium (ABTC) in the U.S. The first patient has been treated in this open-label dose-escalation study to determine the safety and tolerability of the oral formulation of Basilea's novel anticancer drug candidate BAL101553 in combination with standard radiation in patients with newly-diagnosed glioblastoma. Patients participating in the study have a reduced sensitivity to standard chemotherapy with temozolomide due to an unmethylated MGMT promoter.
  • The study is performed at member sites of the ABTC in the United States, coordinated by the Johns Hopkins University's School of Medicine. The ABTC is funded by the U.S. National Cancer Institute (NCI).

Is general: Yes