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DBP International AB: a new patent for SA-033 is granted in China

Double Bond Pharmaceutical's third patent application for organ-specific administration of hydrophilic cancer drug to the liver which forms the basis for the BeloGal® technology platform has been granted in China. Patent approval provides protection for the treatment method and the design of composition for DBP's front-line product SA-033. "We are very pleased because it is an important milestone in the development of balanced product pipeline", - comments Igor Lokot, CEO of DBP. More about SA-033: SA-033 is the first drug candidate that DBP has developed using its innovative drug

DBP International AB: investigators’ meeting for the SI-053 Phase I study was held

Double Bond Pharmaceutical AB (publ) (“DBP”) has today hosted an investigators’ meeting for the planned SI-053 Phase I study. This is an open label dose escalation and dose expansion study, to estimate maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs) and recommended Phase 2 Dose of SI-053 and the first-patient-in is expected to be enrolled during the second quarter of 2021. The meeting gathered investigators from 4 clinics in 2 countries together with the Clinical Trial Team from DBP and key personnel from the contract research organization (CRO) CATO-SMS Oncology.

DBP International AB: positive response for SI-053 from Competent Authority in the Netherlands has been received

Double Bond Pharmaceutical International AB (publ) ("DBP") takes another step towards the start of phase 1 multinational multicentral clinical trial of its front-line product SI-053 in patients with glioblastoma – positive response from Competent Authority in the Netherlands has been received. As previously reported the Clinical Trial Application (EC/CA submission) was sent in the Netherlands. Today DBP received a positive response from the Competent Authority in the Netherlands, Centrale Commissie Mensgebonden Onderzoek, which did

DBP International AB: The EC/CA submission for SI-053 has been sent to the Netherlands

Double Bond Pharmaceutical International AB (publ) ("DBP") takes another step towards the start of the phase 1 multinational multicentral clinical trial of its front-line product SI-053 in patients with glioblastoma - the Ethical Committee/Competent Authority submissions for SI-053 in The Netherlands has also been sent.As previously was reported the Clinical Trial Application (CTA) was sent and the CTA concerned 3 sites in Germany. With the current submission in the Netherlands DBP adds additionally a site for the trial. The process

DBP International AB: next purchase order for Temodex to Columbia

Double Bond Pharmaceutical International AB (publ) ("DBP" or ”Company”) which is a distributor of Temodex continues to work with its partners to register the product in Latin America and China. Today, DBP has received a purchase order for 3 Temodex vials worth approximately $ 10k from its partner in Columbia. "There is a great interest in Temodex/SI-053 in different parts of the world and while we are commencing clinical trials phase I with SI-053 in EU, we will commercialize Temodex on other available markets. With the current order we are happy to provide doctors and patients with

DBP International AB: clinical batch of SI-053 has been manufactured for the upcoming clinical trial phase 1

Double Bond Pharmaceutical International AB (publ) ("DBP") takes a step closer to the start of the Phase 1 clinical trial of its frontline product SI-053 in patients with glioblastoma - batch of SI-053 has been manufactured for the upcoming Phase 1 clinical trial of the EU GMP certified manufacturer.This material will be used in the upcoming Phase 1 clinical trial which is an open dose escalation and dose expansion study to estimate maximum tolerated dose (MTD), identify dose limiting toxicities (DLT) and recommended phase 2 dose (RP2D) of SI-053. "This is another important part of the

DBP International AB: Mexico patent for Temodex / SI-053 is granted

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) has today, June 28th 2021, received information about the granting of Mexican patent application concerning the company's front-line product Temodex / SI-053.Patent approval provides protection for the technology and the product in Mexico until at least 2036."This is a very important milestone in the development of SI-053 as Mexico is a fast growing market where we plan to expand the global commercialization of the product," comments Igor Lokot, CEO of DBP. – “We also have other

DBP International AB: a new patent for SA-033 is granted in USA

Double Bond Pharmaceutical's second patent application for organ-specific administration of hydrophilic cancer drug to the liver which forms the basis for the BeloGal® technology platform has been granted in the United States. Patent approval provides protection for the treatment method and the design of composition for DBP's front-line product SA-033."We are very pleased because it is an important milestone in the development of balanced product pipeline", - comments Igor Lokot, CEO of DBP.More about SA-033: SA-033 is the first drug candidate that DBP has developed using its innovative

DBP International AB: The CTA for SI-053 has been sent - the tenth and the last milestone for the clinical trial of SI-053 has been completed

Double Bond Pharmaceutical International AB (publ) ("DBP") takes a final step towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma - Clinical Trial Application (CTA) for SI-053 has been submitted. Double Bond Pharmaceutical reports that the CTA for SI-053 has been submitted to the competent National Regulatory Authorities, including the Ethics Committee. The process was carried out by DBP in cooperation with a company specializing in managing clinical trials located in the EU, on behalf of pharmaceutical companies. A CTA provides

DBP International: IMPD for the SI-053 phase I trial is finalized – nine out of ten milestones for the clinical trial of SI-053 have been completed

Double Bond Pharmaceutical International AB (publ) ("DBP") takes a step further towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma – the Investigational Medicinal Product Dossier (IMPD) for the upcoming trial is now compiled. The IMPD is a document which contains all the relevant drug development and quality information regarding the manufacturing, testing and packaging of APIs, excipients as well as investigational medicinal products. The document is a central piece of Investigational Medicinal Product (IMP) related documents

DBP International: The Investigator’s Brochure for the SI-053 phase I trial is finalized

Double Bond Pharmaceutical International AB (publ) (“DBP”) takes a step further towards the start of the phase 1 clinical trial of its front-line product SI-053 in patients with glioblastoma - the Investigator’s Brochure (IB) for the coming trial is now compiled. The Investigator’s Brochure (IB) is a comprehensive compilation of pre-clinical and nonclinical data regarding SI-053 maintained by DBP, that contains the body of information about the investigational product obtained before clinical trial. The IB is a document of critical importance throughout the drug development process and

DBP International: The clinical protocol for the SI-053 phase I trial is finalized

Double Bond Pharmaceutical International AB (publ) (“DBP”) takes a step further towards the start of the phase 1 clinical trial of it’s front-line product SI-053 in patients with glioblastoma - the clinical protocol for the coming trial is now finalized. The clinical protocol is an important document that forms the basis for applying for approval to authorities. It must, among other things, contain trial objectives and endpoints, overview that summarizes previous research results in the research area, trial description with presentation of design, treatment regimens including doses and

DBP International: the feasibility studies for clinical site selection for Phase 1 SI-053 clinical trial is finalized - seven out of ten milestones for the clinical trial of SI-053 have been completed

Double Bond Pharmaceutical International AB (publ) (“DBP” or “Double Bond Pharmaceutical”) reports that the feasibility studies for clinical site selection for SI-053 Phase 1 clinical trial have been completed which resulted in the selection of four sites within the EU. This process of the feasibility studies has included: identify clinical investigators who are interested in participating in the trial, assessing site facilities, obtain input from investigators on trial design to align study procedures with clinical practice and support optimal patient recruitment, as well as to understand

DBP International AB: investigators’ meeting for the SI-053 Phase I study was held

Double Bond Pharmaceutical AB (publ) (“DBP”) has yesterday hosted an investigators’ meeting for the planned SI-053 Phase I study. This is an open label dose escalation and dose expansion study, to estimate maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs) and recommended Phase 2 Dose of SI-053 and the first-patient-in is expected to be enrolled during the second quarter of 2021. The meeting gathered investigators from 4 clinics in 2 countries together with the Clinical Trial Team from DBP and key personnel from the contract research organization (CRO) CATO-SMS

DBP International AB: Manufacturing of the excipient for SI-053 is done

The manufacturing of the excipient for SI-053 has been carried out in a European GMP-certified facility, a contract-based manufacturer within the EU. This product will be used for the manufacturing of SI-053 which is scheduled to start next month and which will be used for DBP's clinical trials. DBP has previously reported on successful technical transfer of the excipient for SI-053 and successful SI-053 manufacturing for CTA with associated stability studies, in European GMP-certified environments, which is the basis for today's successful work. "This is an important success for us,

DBP International AB: New patent application for SI-053

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", corporate identity number 556991-6082) has today, March 25, 2021, filed another patent application regarding the Company's front-line product SI-053. DBP's first patent family for SI-053, which protects a formulation, has been granted in Europe, USA, Eurasia and India and is also expected to be granted in other important markets during 2021-2022. With today's patent application, DBP has started work with the next patent family to further broaden the patent protection for the product. "With very promising

DBP International: SI-053 GLP toxicity study in rats is completed - six out of ten milestones for the clinical trial of SI-053 have been completed

Double Bond Pharmaceutical International AB (publ) ("DBP") is delighted to announce that the long term GLP toxicity study of SI-053 in rats has been successfully completed. The purpose of this study was to evaluate the potential toxicity of intracerebral administration of SI-053 in combination with subsequent adapted chemo-radiation treatment (Standard of Care for Glioblastoma). The in vivo model consisted of application of SI-053 at low, middle, and high doses which were followed by one cycle of oral Temozolomide and irradiation in rats. The study also revealed that the excipient

DBP International AB: The sterilization of SI-053 has been validated - five out of ten milestones for the clinical trial of SI-053 have been completed

Double Bond Pharmaceutical International AB (publ) (“DBP”) reports that the sterilization of SI-053 has been validated and completed. The process was carried out by a company specializing in sterilization services located in the EU, in close collaboration with a contracted partner that manufactures SI-053 for the upcoming Phase 1 clinical trial. "This is an important part of the product development, which means that we will provide patients with a sterile and safe product, according to EU requirements" - comments Igor Lokot, CEO of DBP. 10 communicated

DBP International AB: Pharmacokinetic study of SI-053 in animals is completed

Double Bond Pharmaceutical International AB (publ) ("DBP", "Double Bond" or "Double Bond Pharmaceutical") announces positive results from its SI-053 in vivo pharmacokinetic study in rats. SI-053 is Double Bond’s front-line product for local therapy of primary malignancies in the brain. In accordance with the recommendations from the European Agency of Medicines (EMA), DBP has evaluated the local and systemic distribution of temozolomide (TMZ) in the brain, cerebrospinal fluid (CSF) and plasma, and its metabolites after intracerebral injection of SI-053 in rats. The results showed that

DBP International AB: Indian patent for Temodex / SI-053 is granted

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) has today, December 7th 2020, received information about the granting of Indian patent application concerning the company's front-line product Temodex / SI-053. Patent approval provides protection for the technology and the product in India until at least 2036. "This is a very important milestone in the development of SI-053 as India is a fast-growing market where we plan to expand the global commercialization of the product," – comments Igor Lokot, CEO of DBP. – “We also have other

DBP International: Dossier for Inofer acquired

In 2019 a clinical study was conducted in a collaboration between Double Bond Pharmaceutical AB (“Double Bond”) and Skellefteå Lasarett. The study showed that iron succinate significantly improves iron uptake, iron saturation and iron storage in patients with heart failure and iron deficiency. Today, December 7 2020 Double Bond and Laboratorie X.O (France) signed an agreement for the acquisition and rights of Inofer[©]´s (iron succinate) registration dossier for the Nordic market. "We are pleased with the positive clinical results of ferrous succinate´s use. We strongly believe in the

DBP International: seeks international patent for the use of iron succinate

Double Bond Pharmaceutical AB (”Double Bond”) has filed a PCT patent application to protect the use of ferrous succinate for certain indications. Last year, a clinical study was conducted with collaboration between Double Bond  and Skellefteå University, showed that iron succinate significantly improves iron uptake, iron saturation and iron storage in patients with heart failure and iron deficiency. Through its subsidiary Drugsson AB, Double Bond Pharmaceutical AB has the distribution rights for Inofer (iron succinate) in Sweden, Norway, Denmark and Finland. "We are pleased with

DBP International AB: The stability study has been started

Double Bond Pharmaceutical International AB ("DBP") reports that the stability studies for SI-053 have been started. The study is conducted by a company specializing in manufacturing and stability processes and is located within the EU. The studies required for CTA regarding the stability of SI-053 have now been completed and will be added to the regulatory documentation, IMPD. "This enormous milestone takes us one step closer to clinical phase 1. With this, we can state that the product is stable, sterile and can be used safely and securely in humans." - comments Sayeh Erfan, Director

DBP International AB and N.N. Alexandrov National Cancer Center of Belarus has entered into a new agreement about the clinical use of Temodex

Background: On December 5, 2016 Double Bond Pharmaceutical International AB (publ) (“DBP”) announced a collaboration with the N. N. Alexandrov National Cancer Center in Belarus (“Alexandrov Cancer Center”). The main objective of this agreement was to gain access to the experience and resources relevant to the development of DBP's products such as SI-053, a drug to be used to treat brain tumors. In January 2017, the partnership agreement was further developed. It consisted of following up patients with brain tumors treated at that center and aimed to study several key parameters that

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