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Starting the evaluation of Temodex effectiveness in MGMT-positive brain cancer patients

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Today, June 8, 2016, Double Bond Pharmaceutical (DBP) and Department of Pathology at Rigshospitalet (Danish State Hospital) in Copenhagen start a collaboration project aiming to establish MGMT status in patients enrolled in the clinical trial of Temodex performed in Belarus. A positive result of this study will be a great opening towards a possibility to apply Temodex to all patients with glioblastoma and possibly also other types of brain tumors regardless of their MGMT status.

It is known that patients with glioblastoma that are in need of chemotherapy but are MGMT-positive have no use of a standard systemic chemotherapy treatment with temozolomide (Esteller et al. 2000, http://www.nejm.org/doi/full/10.1056/NEJM200011093431901; Hegi et al. 2004, http://clincancerres.aacrjournals.org/cgi/content/long/10/6/1871; Kristensen et al. 2016, http://dx.doi.org/10.1093/jnen/nlv024). Temodex, which allows to apply and retain temozolomide locally into the brain and thereby significantly increase the therapeutic concentration of temozolomide in the brain tissue, is thought to be able to exhaust the MGMT protein storages and thereby be effective even in MGMT-positive patients. To obtain the experimental proof of this hypothesis DBP starts a collaboration project with Department of Pathology at Danish State Hospital in Copenhagen where MGMT methylation analysis is routinely performed in all patients with brain tumors that are in need of chemotherapy. An experienced neuropathologist and a team of molecular biologists will analyze tissues from Temodex-treated patients and controls to establish the MGMT methylation status of the patients and help us to unravel MGMT impact on the effect of Temodex.

-          We see this project as an important step within the validation of Temodex efficiency, and in case we succeed we give a great new hope for MGMT-positive brain tumor patients, which are the majority of all patients with malignant glioma, says Igor Lokot, CEO for Double Bond Pharmaceutical AB.

If it turns out that the MGMT methylation status is not crucial for the efficiency of locally delivered temozolomide then the Temodex treatment will be basically the only and the best choice of chemotherapy treatment for MGMT-positive patients with operable brain tumors.

Information about Temodex

Temodex, which is a locally acting temozolomide formulation, was developed in RI PCP in Minsk, Belarus, and is clinically tested. Temodex is registered as a first line treatment of glioblastoma in Belarus since 2014. For more info: www.doublebp.com

Information about glioblastoma

Glioblastoma, also known as glioblastoma multiforme and Grade IV astrocytoma, is the most common and most aggressive form of the primary brain tumors. It affects glial cells and accounts for 52% of all brain tumors and 20% of all tumors inside the skull. About 50% of patients diagnosed with glioblastoma die within one year after diagnosis, and 90% die within three years.

Full Company Name:           Double Bond Pharmaceutical International AB
Corporate idenity:               556991-6082
Stock short name:               DBP B
Share ISIN code:                 SE0007185525 

        
For more info, contact
Igor Lokot, CEO

Homepage: http://www.doublebp.com/

E-mail: info@doublebp.com

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Information about Double Bond Pharmaceutical International AB

DBP is a pharmaceutical company with activity focused primarily on development of therapies against cancer through own-developed drug delivery technology BeloGal®. In June 2015 the company has received Orphan Drug Status for its first product – SA033 – for treatment of hepatoblastoma from European Medicines Agency (EMA).

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