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DBP's first income from sales of Temodex in Latin Amerika

Today DBP has received their first payment from CLOSTER PHARMA for 3 units of Temodex that will be delivered from the supplier to Colombia shortly. As previously announced, Double Bond Pharmaceutical and CLOSTER PHARMA SAS (Colombia) signed a distribution agreement for Temodex in Mexico, Brazil, Colombia, Peru, Ecuador and Costa Rica in September 2018. At the beginning of November same year, Double Bond Pharmaceutical and Closter Pharma organized an exchange of experience where eight doctors from leading hospitals in Colombia were able to meet and exchange experience with developers,

DBP’s scientific paper about MGMT and Temodex is in PubMed

Double Bond Pharmaceutical’s pilot study on whether MGMT, the well-known biomarker in glioma treatment, can affect the overall survival of brain cancer patients treated with Temodex is now available online at PubMed as “ahead of print”. The paper was, as earlier reported, peer-reviewed by an expert panel and thereafter accepted for publication in Neoplasma. The hard copy of the article in the journal will be issued in the beginning of 2019. "The study results provide an important insight into the potential magnitude of the therapeutic value of Temodex and SI053", - says Igor Lokot, CEO

DBP's first purchase order from Closter Pharma

As previously announced, Double Bond Pharmaceutical and CLOSTER PHARMA SAS (Colombia) signed a distribution agreement for Temodex in Mexico, Brazil, Colombia, Peru, Ecuador and Costa Rica in September 2018. At the beginning of November, Double Bond Pharmaceutical and Closter Pharma organized an exchange of experience where eight doctors from leading hospitals in Colombia were able to meet and exchange experience with developers, manufacturers and users of Temodex in Minsk, Belarus. For three days, they had the opportunity to be with their Belarussian colleagues and see with their own eyes

DBP gets free Protocol Assistance from EMA for SI-053

Double Bond Pharmaceutical has submitted an application to EMA for scientific advice, known as Protocol Assistance, for SI-053. The assistance will be given during a pre-submission meeting, where DBP is able to get advice on issues and plans that exist for SI-053 before the more formal procedure starts. The assistance is free of charge since the product has orphan drug status, and is expected to be completed in March 2019. Double Bond Pharmaceuticals goal is to then start the clinical trial with SI-053 as soon as possible. “The possibility to consult the agency to discuss the development

Patent protecting Temodex and SI053 covering the Eurasian market has been granted

The institution of Physical and Chemical Problems´ (Minsk) patent application, which protects Temodex and SI053 has been granted by the Eurasian Patent Organization (EAPO). The patent approval provides protection for the products on the Eurasia market at least through 2036. The Eurasian patent is a part of a patent family filed in collaboration with Double Bond Pharmaceutical. The international patent application protecting SI053 received a positive Written Opinion during the international phase, and has just entered the national phase in US, EP, Asia, and other countries of interest. "I

Double Bond Pharmaceutical and Closter Pharma perform experience exchange

In week 44, i.e during 29/10 – 2/11, eight doctors from leading hospitals in Colombia will meet and exchange experiences with developers, manufacturers and users of Temodex in Belarus. During three days, they have the opportunity to be with their Belarussian colleagues and see with their own eyes how Temodex is manufactured and used on site. "It is gratifying to meet the enthusiasm of our colleagues from Colombia and see their zeal to learn more about Temodex" -commented Igor Lokot, CEO of Double Bond Pharmaceutical. "I am proud to be part of introducing our innovative product in Latin

Double Bond aims on adaptive design for SI-053 Phase I

Double Bond Pharmaceutical (DBP) has signed a service contract with Cytel Inc, a leading provider of clinical research services and software, to develop an adaptive model-based study design for upcoming Phase I clinical trial for SI-053. “In our planned Phase I dose-escalation study we aim on using an adaptive model-based design to help identify the maximum tolerated dose (MTD) of SI-053, - says Dr Breezy Lindqvist, CMO of DBP. - This is considered to be much more effective than the traditional 3+3 model and is a crucial step in the clinical development of SI-053, as it also decides the

Two studies start simultaneously to verify the toxicological safety profile of SI-053

Today, a pre-clinical toxicological GLP study will start to verify the safety profile of SI-053 in a certified laboratory in Italy. The possibility to conduct this study is a result of a successful pre-study and a fruitful cooperation between two laboratories that developed an administration method that resembles the planned intracerebral administration in humans. The experimental part of the study will take about 3 weeks and the final report with all data evaluated is expected in July. This toxicological study is in accordance with European guidelines for drug development (GLP) and will be

No serious adverse effects in GLP-tox preliminary study for Temodex

Double Bond Pharmaceutical (DBP) has initiated the toxicological evaluation of the company's drug candidate against brain cancer, Temodex, as announced earlier. This study package is intended to demonstrate the safety of Temodex in the brain in rats to clarify the improved safety profile seen in previous studies. The toxicological package begins with a preliminary study followed by the major GLP study.The first animals have now been dosed in the preliminary study without observing any serious adverse effects."The preliminary results we have obtained are entirely in line with the

New study confirms safety of Temodex and shows it to be restrictive to the right organ

Double Bond Pharmaceutical has now completed a study investigating how much Temodex - the novel drug against brain cancer - spreads in the brain in rat. The purpose of the study was to follow and chart the concentration of the active substance and its metabolite in both brain and blood circulation. The study is one in the line of complementary preclinical studies to prove and strengthen proof of concept for the company's drug candidate against brain cancer - Temodex. The results show, among other things, that the concentration of active substance in rat brain is several times above the

Positive judgement on the international patent application for Temodex

Double Bond Pharmaceutical AB has now received a positive judgement on a comprehensive review of the international patent application for Temodex – the novel therapy against brain cancer. The European Patent Office (EPO) was selected as the Examining Authority to get a critical and detailed analysis on how the application will be reviewed and evaluated by EPO in the European phase. The international patent application (PCT) for Temodex was submitted by Double Bond Pharmaceutical on April 28th 2017. "It is extremely important for Double Bond Pharmaceutical that EPO considers our patent

DBP signed a "Memorandum of Understanding" with international partner regarding a possible licensing agreement on development of Temodex

Today, the 5thof April, DBP AB has signed a so-called "Memorandum of Understanding" (MoU) with a potential partner for the development of Temodex. Development involves clinical development, manufacturing, marketing, distribution and othr product-related activities. MoU describes the cooperation terms between DBP and the upcoming partner and can potentially lead to an exclusive license agreement on the development of Temodex. DBP builds today a portfolio of drug candidates for various types of cancers. These candidates should then be outlicensed for commercialization. Temodex - acting

Promising results for Temodex, drug candidate against brain cancer, after completion of the first MGMT study

Preliminary results indicate that there is no significant difference in survival between MGMT methylation-positive and negative patients treated with Temodex, and that all patients who received Temodex had a significantly better survival than the control group when both DNA and protein data for MGMT were taken into account. This result will later this year be presented at scientific meetings and in scientific journals. Further studies on a larger group of patients are scheduled to start shortly. "MGMT status permits to distinguish patients who respond well or respond poorly to standard-

Double Bond Pharmaceutical AB and N.N. Alexandrov National Cancer Centre of Belarus has entered into agreement about clinical use of Temodex.

DBP announced 5 december 2016 that the company started a collaboration with N. N. Alexandrov National Cancer Centre of Belarus. The main goal was to get access to skills and resources that are relevant to the development of DBP’s products including Temodex that is a drug against brain cancer. The cooperation has been now further developed through a partnership agreement concerning a follow-up of patients with brain tumors treated in Belarus in N. N. Alexandrov National Centre, which will accelerate the process of making Temodex commercially viable worldwide. Under the agreement, all

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