Update regarding the clinical results from the phase II study of TEMODEX
Double Bond Pharmaceutical AB (DBP) presents today an update regarding the clinical study on TEMODEX, the company's new asset in brain cancer treatment, which was used in combination with the standard treatment consisting of surgical resection, radiotherapy, and concomitant temozolomide therapy followed by adjuvant chemotherapy with temozolomide.
The data from this trial show that in 39 patients with advanced glioblastoma and astrocytoma, the use of TEMODEX gives a median overall survival of 18.1 months compared to 9.7 months for the control group, consisting of 89 patients and given the standard treatment. Treatment-related adverse events in the TEMODEX group were similar to those in the control group.
"We have demonstrated a significant improvement in survival of patients treated with TEMODEX in combination with the standard treatment for an intractable disease such as glioblastoma and astrocytoma," says Dr Igor Lokot, CEO of DBP. "Our next step is to summarise all the data and based on advice from the regulatory authorities develop the best possible strategy for a registration of the product in Europe".
TEMODEX, which is a locally acting form of temozolomide, was developed by the RI PCP in Minsk in Belarus and has successfully been clinically assessed. TEMODEX is registered as a first line treatment of glioblastoma multiforme in Belarus since 2014. For more info: www.doublebp.com
Additional Information about the Clinical Trial of TEMODEX
The study was carried out at Minsk City Emergency Hospital (Belarus) starting in November 2012 and the last patient was recruited in December 2013. The latest follow-up data from living patients were obtained in October 2015. It is planned to present the details of the study at national and international scientific conferences. Which exactly conferences it will be depends on which conferences would be willing to present the data.
About Glioblastoma Multiforme
Glioblastoma multiforme, also known as glioblastoma and grade IV astrocytoma, is the most common and aggressive malignant form of all primary brain tumors. It affects glial cells and accounts for 52% of all brain tissue tumor cases and 20% of all tumors inside the skull. About 50% of the patients diagnosed with glioblastoma die within one year and 90% within three years.
: Double Bond Pharmaceutical International AB
Corporate identity number : 556991-6082
Stock short name : DBP B
ISIN code : SE0007185525
Information about Double Bond Pharmaceutical International AB:
DBP is a pharmaceutical company that primarily develops drugs against cancer through its proprietary drug delivery technology. The company was granted Orphan Drug status by the European Medicines Agency in June 2015 for its first product, SA033, for treatment of hepatoblastoma.