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DBP receives EU funding SME instrument Phase I

As previously announced, Double Bond Pharmaceutical has submitted an application to the European Commission for an SME instrument grant within the framework of the Horizon2020 program, where groundbreaking innovation projects with market-generating potential can be supported. The company funds alone to implement a more in-depth and up to date business plan for continued successful development of SI053. The project under the name TARGLIO has now been funded with the amount of SEK 500,000, which corresponds to the entire sought amount and is the ceiling for this type of grant. "I am glad

Scientific Advice from EMA continues

As previously announced, Double Bond Pharmaceutical has submitted a Protocol Assistance request to EMA to obtain scientific advice regarding SI-053 and has now received the answers to their questions. After reviewing the answers, some advice revealed to require a more detailed clarification and the company has therefore sent supplementary questions to EMA to ensure the best strategy for product development in crucial detail and the optimal planning of coming steps. The advice from EMA is be based on a number of questions from DBP mainly

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,

Scientific Advice from EMA is due the first week of March

As previously announced, Double Bond Pharmaceutical has submitted a Protocol Assistance request to EMA to obtain scientific advice regarding SI-053 . The advice from EMA will be based on a number of questions from DBP mainly regarding the preclinical development of SI-053 and the planned Phase I trial in glioblastoma patients. DBP expects useful advice for the product development. Yesterday, DBP were noticed that a final advice letter will be obtained from EMA during the first week in March. The Protocol Assistance is free of charge

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

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