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Double Bond Pharma signs agreement for distribution of Helixor products

Double Bond Pharmaceutical (DBP) and Helixor Heilmittel GmbH have today signed an agreement for distribution of Helixor products in Sweden. The distribution will be held through Drugsson AB. Helixor products are used as integrative cancer therapy, which means that they are given to the patient to decrease severe side effects from their current medication and substantially increase quality of life. Helixor products are available for integrative treatment of different types of cancers, both common and rare cancers, including breast cancer, colorectal cancer, lung cancer and brain cancer.

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

Double Bond Pharma signs logistics agreement with Tamro

Today, Double Bond Pharmaceutical has signed an agreement with the wholesaler Tamro for distribution and storage of its product Pileseptin in Sweden, Norway and Denmark. Tamro is Sweden’s only independent pharmaceutical logistics service provider and is known to have both the world-class knowledge and experience in this type of services. Pileseptin, a product that Double Bond signed a distribution agreement for in December 2017, is an innovative formulation that strengthens the healing effect of hemorrhoids, and is part of Double Bond’s venture into drug distribution through its subsidiary

Double Bond Pharma signs agreement for distribution of Pharysol

Double Bond Pharmaceutical (DBP) and Vitro-Bio have today signed an agreement for distribution of Pharysol in Sweden, Norway and Denmark. The distribution will be held through Drugsson AB. "In line with our goal to build a self-sustaining pharmaceutical company with a balanced portfolio consisting of both innovative development products and ready-to-sell unique products we are very pleased to be able to expand our collaboration with Vitro-Bio in terms of distribution of broader line of their products. Pharysol is a treatment against common cold and expected to bring the largest revenue

Double Bond Pharma signs distribution agreement with Belmedpreparaty

Double Bond Pharmaceutical (DBP) has signed an agreement with RUE Belmedpreparaty for distribution of selected dietary supplements on the Scandinavian market. Sales of these products will be managed by the newly established subsidiary of DBP, Drugsson AB.High quality dietary supplements can substantially improve quality of life for people with impaired uptake of crucial nutrients from the diet and people with increased nutritional needs during a certain situation in life. It is therefore important to be able to introduce high quality products to the market that can match these needs and

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

The pre-clinical toxicological development of SA-033 is now completed

DBP has now completed the final part of the toxicological studies required to apply for clinical trials of SA-033 – drug candidate against cancers in liver. SA-033 is a novel self-navigating formulation based on the known cancer drug doxorubicin.The final part of the pre-clinical development was comprised of a toxicology study performed in accordance to GLP-standard (i.e. the highest standard) where the ordinary doxorubicin was compared with the SA- 033 formulation. The purpose of this part of the toxicology program was to develop a detailed profile of SA-033 toxicity. The results show

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

Double Bond Pharmaceutical expands the cooperation with Alexandrov Cancer Centre to identify biomarkers for Temodex

As previously described, DBP has recently started an extensive partnership agreement with N. N. Alexandrov National Centre of Belarus on Temodex. Now the cooperation is deepened further and includes the identification of potential biomarkers for Temodex. "Biomarkers are absolutely central in the development of modern drugs, especially as so-called personalized medicine becomes increasingly vital in the pharmaceutical world. We see a great potential and opportunities in effective development of biomarkers, - says Igor Lokot, CEO of DBP. - This ensures further the therapeutic value of

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

Double Bond Pharmaceutical AB has started a scientific and technological collaboration with N. N. Alexandrov National Cancer Centre of Belarus

DBP and N. N. Alexandrov National Cancer Centre of Belarus will initiate the collaboration program immediately. The main goal for DBP is to get access to the knowledge and resources that are relevant to the development of DBPs front-line products - drugs SA-033 against liver cancer and Temodex against brain cancer - already from December 2016. "We are excited to be part of a long-term collaboration with N. N. Alexandrov National Cancer Centre of Belarus. This governmental organization can be a great resource and advisory board for the DBP within some clinical and technical

DBP introduces SA-101, a new drug candidate for the treatment of solid tumors, that is now entering the preclinical stage of development.

DPB announced today that SA-101 has been selected as its next drug candidate. Hereby, SA-101 is officially entering the preclinical phase of drug development, which is the first step for a successful drug candidate towards marketing. SA-101 targets solid tumors and is based on a new drug delivery mechanism. "We are building a portfolio of several drug candidates for those types of cancers that currently lack good treatments, said company CEO Igor Lokot. Through our broad yet focused product strategy with several oncological drug candidates in the pipeline in different stages of

The Annual report for Orphan Drug Designation status for SA-033 received no remarks from EMA

Double Bond Pharmaceutical International AB (DBP) has the 20th of September submitted the Annual report for the drug candidate SA-033 to the European Medicines Agency (EMA), which is mandatory after obtaining Orphan Drug Designation status. The Annual report received no remarks or objections, which means that the development of the product is in line with EMA’s requirements and expectations. The company was originally granted Orphan Drug Designation status in June 2015 by EMA for SA-033. The Designation applies to the treatment of hepatoblastoma, which is the most frequent type of liver

Double Bond Pharmaceutical AB has been granted Orphan Drug Designation status by EMA for the drug candidate Temodex.

July 22, 2016 Double Bond Pharmaceutical (DBP) has been officially granted Orphan Drug Designation (Orphan Drug) status for the drug candidate Temodex by the European Medicines Agency (EMA). The approval applies to the treatment of glioma, which is the most common type of brain cancer. Ten years of market exclusivity for the indication and a great support from the authority will hereby be given to DBP to accelerate the development of the drug. The EMA grants Orphan Drug Designation status to drugs that treat diseases with less than 200 000 people affected in Europe. For DBP this means

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

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

Gold medal to Belorussian State University for development and marketing of Temodex

Belorussian State University has in 2015 received a 1-st grade Diploma and a gold medal at RESTEC® HiTech exhibition forum in St. Petersburg for the development of Temodex – pharmaceutical formulation for local chemotherapy treatment of brain tumours. The prize was received in the category “Best Innovation Project: successful product marketing, best manufacturing, best stock handling and best logistics”. About TemodexTemodex, which is a locally acting form of temozolomide, was developed by the Research Institute of Physical and Chemical Preparations at Belorussian State University in

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

Double Bond Pharamceutical AB acquires Temodex, a locally acting brain tumor therapy based on temozolomide

· DBP will expand and diversify the company’s portfolio by acquiring Temodex indicated for the treatment of glioblastoma from RI PCP in Belarus · This transaction underscores DBP’s commitment to become a leading supplier of first-in-class drug delivery platforms, offering patients a wide range of treatments for oncology diseases while simultaneously delivering value to shareholders · DBP will acquire the global rights to Temodex, excluding the Eurasian Economic Union and Ukraine Double Bond Pharmaceutical AB announced today that it has entered into an agreement for the acquisition

Double Bond Pharmaceutical AB has been granted Orphan Drug status for the drug candidate SA-033 by EMA.

%20has%20been%20granted%20Orphan%20Drug%20Designation%20(Orphan%20Drug)%20status%20for%20the%20drug%20candidate%20SA-033%20by%20the%20European%20Medicines%20Agency.%20The%20approval%20applies%20to%20the%20treatment%20of%20hepatoblastoma%20which%20is%20the%20most%20common%20type%20of%20liver%20cancer%20that%20affects%20children.%20Ten%20years%20of%20market%20exclusivity%20for%20the%20indication%20and%20a%20great%20support%20from%20the%20authority%20will%20hereby%20be%20given.%20)Double Bond Pharmaceutical AB (DBP) has been granted Orphan Drug

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