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DBP International AB: transition of the SI053 clinical trials protocol to a new Clinical Trial Information System has been completed

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) is pleased to announce the successful transition of its clinical study "An open-label dose escalation study to estimate the maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs), and study pharmacokinetics following a single dose of intracranially administered temozolomide-based SI-053 as an add-on to the current standard of care (SoC) in adult patients with newly diagnosed glioblastoma (GBM)," to a new Clinical Trial Information System (CTIS). Adoption to this on-line system

DBP International AB and Vivo Biopharma LLC: Revised Asset Purchase and Collaboration Agreements

Double Bond Pharmaceutical International AB (publ) (“DBP”) and Vivo Biopharma LLC (“Vivo”), today announced an amendment to the Asset Purchase and Collaboration Agreements for DBP’s SI-053 and related assets, originally signed on September 17, 2023.  SI-053 is a locally acting formulation of temozolomide for the treatment of glioblastoma, which received Orphan Drug Designation from the European Medicines Agency in 2016. Recently, SI-053 received both Competent Authority and Ethics Committee approvals to initiate a Phase 1 clinical trial in two Western European countries. The amendment to

DBP International AB: European patent for the technology platform BeloGal® is granted

Double Bond Pharmaceutical International AB (publ) ("DBP" or the "Company", org. no. 556991-6082) has today, May 29, 2024, received information about the granting of a European patent application for organ-specific administration of hydrophilic cancer drugs to the liver. This applies, among other things, to one of the company's frontline products SA-033 for the treatment of liver cancer, which is based on the technology platform BeloGal®. The patent approval means protection for the product in 26 countries within the European Patent Office (EPO) at least until the year 2035. "The granted

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

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) has today, January 23[rd] 2024, received information of the approval of a Brazilian patent application concerning the company's front-line product Temodex / SI-053.Patent approval provides protection for the technology and the product in Brazil until at least 2036. "This is an important milestone in the development of SI-053 to get product patented and this is very good news for the company especially now prior starting clinical trials”, comments Igor Lokot, CEO of DBP. – “We also have other

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

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) has today, January 9[th] 2024, received information of the approval of a Canadian patent application concerning the company's front-line product Temodex / SI-053. Patent approval provides protection for the technology and the product in Canada until at least 2036. "This is an important milestone in the development of SI-053 to get product patented and this is very good news for the company especially now prior starting clinical trials”, comments Igor Lokot, CEO of DBP. – “We also have

Supplement to Press Release: DBP International AB and Vivo Biopharma LLC Enter into Asset Purchase and Collaboration agreements to Develop and Commercialize a novel Glioblastoma Treatment

The press release is supplemented with the paragraph "Further details of the agreements"Double Bond Pharmaceutical International AB (publ) (“DBP”) and Vivo Biopharma LLC (“Vivo”), a wholly owned subsidiary of Sauvie Inc. (“Sauvie”) today announced that they have entered into an asset purchase, collaboration and transition agreements for DBP’s SI-053 development product and related assets. SI-053 is a locally acting formulation of temozolomide for the treatment of glioblastoma and it received Orphan Drug Designation from the European Medicines Agency in 2016.  Recently, SI-053 received both

DBP International AB and Vivo Biopharma LLC Enter into Asset Purchase and Collaboration agreements to Develop and Commercialize a novel Glioblastoma Treatment

Double Bond Pharmaceutical International AB (publ) (“DBP”) and Vivo Biopharma LLC (“Vivo”), a wholly owned subsidiary of Sauvie Inc. (“Sauvie”) today announced that they have entered into an asset purchase, collaboration and transition agreements for DBP’s SI-053 development product and related assets. SI-053 is a locally acting formulation of temozolomide for the treatment of glioblastoma and it received Orphan Drug Designation from the European Medicines Agency in 2016.  Recently, SI-053 received both Competent Authority and Ethics Committee approvals to initiate a Phase 1 clinical trial

DBP International AB: Full approval for SI-053 from The Ethics Commission of the Faculty of Medicine of Cologne University in Germany has been received

Double Bond Pharmaceutical International AB (publ) ("DBP") is very delighted to announce that the company has received for its product SI-053 full approval for starting clinical trials in Germany, in patients with glioblastoma.Up to now, the SI-053 has obtained all approvals from the countries (Germany and the Netherlands) where the clinical trial is to be conducted. "We are very excited to reach this crucial milestone. It is a result of lots of hard work done by our excellent colleagues, our preclinical and clinical partners, external consultants and KOLs, and all our investors who have

Correction: DBP International AB: investee company Bio Vitos has yesterday reached agreement with Hemcheck

The correction refers to the letter in the press release on February 8 at 07:48 CEST: The MAR label was put there by mistake and the agreement between Bio Vitos and Hemcheck was signed yesterday.   Double Bond Pharmaceutical International AB (publ) ("DBP") notes the announcement released earlier yesterday by Hemcheck Sweden AB (“Hemcheck”) and is pleased to announce that its 20% owned investee company Bio Vitos has today entered into an agreement with Hemcheck, a company listed on the Nasdaq Stockholm (the “Agreement”).  As part of the Agreement Hemcheck will create a new subsidiary (“

DBP International AB: investee company Bio Vitos has today reached agreement with Hemcheck

Double Bond Pharmaceutical International AB (publ) ("DBP") notes the announcement released earlier yesterday by Hemcheck Sweden AB  (“Hemcheck”) and is pleased to announce that its 20% owned investee company Bio Vitos has today entered into an agreement with Hemcheck, a company listed on the Nasdaq Stockholm (the “Agreement”).  As part of the Agreement Hemcheck will create a new subsidiary (“NewCo”) and transfer all current business and assets of Hemcheck to this new subsidiary. Under the terms of the Agreement, Bio Vitos has agreed to provide the NewCo with  SEK1.23 million in cash, plus

DBP International AB: favorable response for SI-053 from The Ethics Commission of the Faculty of Medicine of Cologne University in Germany has been received

Double Bond Pharmaceutical International AB (publ) ("DBP") is about to take a very important step towards the start of clinical trial phase 1 in Germany of its front-line product SI-053 in patients with glioblastoma – a positive response from The Ethics Commission of the Faculty of Medicine of Cologne University (Central Ethics Committee, CEC) in Germany  has now been received. This favorable approval is conditional in nature, and DBP is currently revising Informed Consent form and supporting forms with minor changes as per the recommendation from the CEC. Germany is accordingly the second

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

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) has today, November 1st 2022, received information of the approval of an Australian patent application concerning the company's front-line product Temodex / SI-053. Patent approval provides protection for the technology and the product in Australia until at least 2036. "This is an important milestone in the development of SI-053 to get product patented and this is very good news for the company especially now prior starting clinical trials”, comments Igor Lokot, CEO of DBP. – “We also

DBP International AB: positive response for SI-053 from the Federal Institute for Drugs and Medical Devices in Germany has been received

Double Bond Pharmaceutical International AB (publ) ("DBP") is about to take a very important step towards the start of clinical trial phase 1 in Germany of its front-line product SI-053 in patients with glioblastoma – a positive response from Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte) in Germany has now been received. Germany is the second country to approve the start of the phase 1 clinical trial; a positive response from Ethical Committee in the Netherlands was received in September 2021

DBP International: Positive opinion in international phase (PCT) of patent application for iron succinate

Double Bond Pharmaceutical International AB (publ) (“DBP”) is pleased to announce a positive written opinion regarding their international patent application relating to iron succinate (Inofer) for treatment of patients diagnosed with heart failure with reduced ejection fraction (HFrEF). The application enters the national phase in May 2022. The results of clinical trials undertaken by DBP indicate that ferrous succinate (“Inofer”) markedly and significantly improved iron uptake, iron saturation, and iron stores in patients with heart failure and iron deficiency. Inofer is a low-cost

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

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) has today, February 11th 2022, received information about the granting of a Japanese patent application concerning the company's front-line product Temodex / SI-053. Patent approval provides protection for the technology and the product in Japan until at least 2036. "This is a very important milestone in the development of SI-053 as Japan is one of the biggest markets where we plan to expand the global commercialization of the product," comments Igor Lokot, CEO of DBP. – “We also have

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

Double Bond Pharmaceutical's forth 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 Japan. 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: positive response for SI-053 from Ethical Committee in the Netherlands has been received

Double Bond Pharmaceutical International AB (publ) ("DBP") takes the final step towards the start of clinical trial phase 1 in the Netherlands of its front-line product SI-053 in patients with glioblastoma – positive response from Ethical Committee of the Netherlands (Medisch Ethische Toetsings Commissie) has been received.   "We are very pleased to have succeeded in reaching this important milestone in the development of SI-053 to satisfy the unmet medical needs of patients suffering from Glioblastoma." - comments Igor Lokot, CEO of DBP. “We are now very enthusiastic to find the most

DBP International AB Extends Joint Venture Agreement with Shijiazhuang Yuanta Biotechnology for Temodex to Hong Kong and Macao

Double Bond Pharmaceutical International AB (publ) ("DBP") has today extended the agreement with Shijiazhuang Yuanta Biotechnology Co., Ltd ("SYB") regarding setting up a joint venture in China for commercialization of Temodex in the Chinese market to Hong Kong and Macao. Initial agreement dated May 21, 2020 related to territory of mainland China. Under the terms of the agreement DBP grants to the joint venture exclusive rights for the product for 25% of shares of the joint venture as well as €0.5 million of milestones payment conditioned by formal market approval of Temodex in China.

DBP International AB: Named Patient Early Access Program with Temozolomide gel (Temodex®) has been launched

Double Bond Pharmaceutical International AB (publ) (“DBP” or “Double Bond”) are pleased to announce that as of November 23 they have launched a Named Patient Treatment Access Program for Temozolomide gel (Temodex®) to provide a ground-breaking new treatment paradigm for Glioblastoma patients across the globe prior to global registration. Glioblastoma, the most common and aggressive malignant form of all primary brain tumours, affects glial cells and accounts for 52% of all brain tissue tumour cases and 20% of all tumours inside the skull.  Approximately 250 000 patients with

DBP International: 20% of the shares of Bio Vitos is received

Double Bond Pharmaceutical International AB (publ) (“DBP”) is today able to confirm that it has received as agreed 10,010,000 (ten million and ten thousand) new ordinary shares of GBX 0.1 par value each of Bio Vitos, representing 20 (twenty) per cent of the issued share capital of Bio Vitos prior to the share issue to the Company in consideration for the previously-disclosed license over its intellectual property regarding ferrous succinate granted to Bio Vitos by DBP. A Confirmation Statement showing the share issuance was filed on Bio Vitos’ behalf with the Registrar of Companies in the

DBP International AB has together with Bio Vitos Medical Ltd signed an agreement on scientific, technical and sales collaboration with Belarusian Academpharm

Double Bond Pharmaceutical International AB (publ) (“DBP”) has signed a 3-way agreement with Bio Vitos Medical Ltd (“Bio Vitos”) and Academpharm (Republic of Belarus) concerning a technical and scientific collaboration. The purpose of the agreement between Academpharm and Bio Vitos is to get access to its products on the markets in the Eurasian Economic Union (EaEU). Bio Vitos has a line of more than 40 Omega 3 products from North Norway, containing vitamins, minerals, iron succinate etc. The Bio Vitos agreement with Academpharm, gives access to the countries: Belarus, Russia,

DBP International: Signed a collaboration partnership agreement with Alexavi for commercialization of Temodex®

Double Bond Pharmaceutical International AB (publ) (“DBP” or “Double Bond”) has entered into a collaborative partnership with Alexavi Ltd (“Alexavi”). This is a major step in Double Bond’s development process and marks the company’s commitment to move forward towards approval and commercialisation of Temodex® program, for the treatment of Glioblastoma. This collaboration will open up accessibility to a ground-breaking treatment paradigm in this therapeutic area.  Alexavi will be managing an Early Access to Treatment program on behalf of Double Bond to raise awareness of the treatment’s

DBP International: Out-licensing to YRRO rights for an international patent for the use of ferrous succinate

Double Bond Pharmaceuticals AB (publ) (“DBP”) has entered into an agreement with YRRO Ltd (“YRRO”) to sell the license for use of its intellectual properties including international patent application for active substance ferrous succinate, marketed as “Inofer”, in the USA, Japan, China and the EU (excluding the Nordic countries). Clinical trial results undertaken by DBP indicate that ferrous succinate (“Inofer”) markedly and significantly improved iron uptake, iron saturation, and iron stores in patients with heart failure and iron deficiency. Inofer is a low-cost oral alternative to

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