Project Temodex for treatment of brain cancers
We are looking for a potential partner for Temodex, a novel treatment of brain cancers such as glioma/glioblastoma, to advance development and take on global or regional commercialization of the product. The currently standard of care treatment prolongs the survival in patients but there is a large need for improved remedies. Temodex, offering such an improvement, is a novel product based on temozolomide that is locally administered in the cavity formed after resection of brain tumors.
Double Bond Pharmaceutical AB has acquired global rights for Temodex from the Research Institute of Physical and Chemical Problems (RI PCP) in Belarus. DBPs market share covers all countries except the Eurasian Economic Union (Russia, Belarus, Kazakhstan, the Republic of Armenia, the Kyrgyz Republic), and Ukraine. Temodex was registered as a first line treatment of glioblastoma in Belarus 2014. Double Bond Pharmaceutical is currently focused on the registration of Temodex in EU, USA and other major markets.
Clinical studies performed
A phase II study has been performed at a single site in Belarus, comparing standard of care plus Temodex with solely standard of care. Forty one patients with malignant supratentorial brain tumours of Grade II-IV were included and compared with a historical control of 95 patients. Standard of care in Belarus is constituted of surgery followed by radiation therapy and concomitant temozolomide during 6 weeks followed by adjuvant temozolomide for up to 6 cycles. The median progression free survival was significantly longer for patients in the Temodex group compared to the control group: 16.1 versus 8.2 months, respectively. The median overall survival was also significantly longer for patients in the Temodex group compared to the control group: 18.3 versus 9.8 months, respectively. Adverse events during the first ten days after surgery were observed in nearly 10% of patients in the Temodex group versus in 13% of patients in the control group. Overall, the type and frequency of adverse events in the Temodex group did not differ from those in the control group.