Date: 2016-06-02
Type of information: Results
phase: preclinical
Announcement: results
Company: Onxeo (France)
Product: Beleodaq® oral formulation (belinostat)
Action
mechanism: histone deacetylase inhibitor. Belinostat is a small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and bortezomib for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. Beleodaq® (belinostat) has received accelerated approval by the FDA for the treatment of relapsed or refractory peripheral T-cell lymphoma in July 2014.
Disease:
Therapeutic area: Cancer - Oncology - Rare diseases
Country:
Trial details:
Latest
news: * On June 2, 2016, Onxeo announced the first set of positive results from a preclinical pharmacokinetic (PK) study on the
bioavailability of an oral formulation of belinostat (Beleodaq®) and the next steps in its development plan for the new formulation. The current formulation of belinostat is a lyophilized formulation for intravenous use. The aim of the
company is to develop an oral formulation of belinostat offering strong benefits for patients and physicians in terms of compliance, as well as opening new opportunities for indications for which an oral formulation of belinostat is relevant.
The company has performed a canine PK bioavailability study to screen two enabling formulation technologies dedicated to improving solubility and assessed two prototypes selected based on dissolution properties, and physical and chemical stability. Findings from this study showed a good level of bioavailability approaching the theoretical maximum achievable as indicated by the performance of the oral solution. Onxeo will then select the best of the two formulation technologies, to pursue formulation development and obtain a suitable clinical prototype and, in parallel, fine tune the optimal dosing regimen to then start clinical development in selected indications.
