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Senaste pressmeddelanden och rapporter för bevakat bolag.

Datum Källa Rubrik Typ Alternativ
2022-08-16 OncoZenge OncoZenge AB delårsrapport jan-jun 2022 Rapporter Ladda ner | Visa Stäng
2022-06-30 OncoZenge OncoZenge AB: Kommuniké från OncoZenges årsstämma den 30 juni 2022 Pressreleaser Ladda ner | Visa Stäng
2022-06-08 OncoZenge OncoZenge AB: OncoZenge årsredovisning för räkenskapsåret 2021 offentliggjord Rapporter Ladda ner | Visa Stäng
2022-05-31 OncoZenge Kallelse till årsstämma i OncoZenge AB (publ) Pressreleaser Ladda ner | Visa Stäng
2022-05-17 OncoZenge OncoZenge AB delårsrapport jan-mar 2022 Rapporter Ladda ner | Visa Stäng
2022-04-22 OncoZenge OncoZenge AB: OncoZenge påbörjar omformulering av BupiZenge[®], inleder process för att bredda bolagets verksamhet och senarelägger årsstämman Pressreleaser Ladda ner | Visa Stäng
2022-04-12 OncoZenge OncoZenge AB: OncoZenge avbryter den planerade patientstudien med BupiZenge[®] Pressreleaser Ladda ner | Visa Stäng
2022-02-15 OncoZenge OncoZenge AB bokslutskommuniké 2021 Rapporter Ladda ner | Visa Stäng
2022-02-15 OncoZenge OncoZenge AB: OncoZenge initiates toxicity study and announces modification to the clinical plan Pressreleaser Ladda ner | Visa Stäng
Pressreleaser | 15 Feb 2022 | OncoZenge

OncoZenge AB: OncoZenge initiates toxicity study and announces modification to the clinical plan

Bupivacaine, which is the active pharmaceutical ingredient in BupiZenge[®], is the most widely used anesthetic for epidural anesthesia during childbirth, as well as for post-operative pain treatment. The compound and its safety profile has been extensively studied since it was first discovered more than sixty years ago. BupiZenge[®] has a new and patented formulation which is administered via lozenges for prolonged pain relief in the mouth and pharynx. The study aims to generate supplemental safety data for bupivacaine regarding local and systemic toxicity upon repeated oral topical administration over a longer time period.

The study will comprise six weeks of dosing, followed by laboratory- and data analysis. The start of OncoZenge’s planned pharmacokinetic study in cancer patients with oral mucositis, which forms part of the remaining clinical program, is not dependent on the conclusion of the toxicity study.

OncoZenge’s strategy has been and remains to conduct a development program for product approval in Europe. At the same time, the company wishes to ensure that investments made in clinical development generate data that will support regulatory approvals in both Europe and the US. Also, in conjunction with negotiations with potential commercial partners or buyers, it is necessary to have a documented understanding of the regulatory requirements to reach the US market.
As previously communicated, OncoZenge has initiated formal correspondence with the American Food & Drug agency FDA in order to fully understand the agency’s requirements regarding study design and patient population. The FDA has announced delays on two occasions due to a shortage in resources and their response is now expected at the end of March. OncoZenge’s previous plan was to conduct the remaining clinical development program under a combined study protocol that started with a pharmacokinetic study in H1 2022 and subsequently proceeded with a phase III study. In order to both start the pharmacokinetic study according to schedule, while retaining the possibility to potentially modify the phase III protocol based on FDA’s requirements, the pharmacokinetic study will be conducted under a separate study protocol. In parallel, OncoZenge will decide on design, geographic scope and final study protocol for the phase III study based on the outcome from the company’s interactions with the FDA. The company’s target to have topline data from the European phase III study end of 2023 remains unchanged.

OncoZenge is developing BupiZenge[®] as a novel treatment for pain relief in patients suffering from oral pain caused by oral mucositis, induced by radiation therapy and chemotherapy for cancer. In phase 2 patient studies, BupiZenge[®] has shown significantly better local pain relief compared with today’s standard therapy. Five million people worldwide suffer from oral mucositis caused by cancer therapy. After radiotherapy in the head and neck region, ninety percent of patients develop oral mucositis and of the patients treated with chemotherapy, about thirty percent are affected. Oral mucositis causes severe pain, interruption of cancer treatment and may significantly increase healthcare costs.

2022-02-15 OncoZenge OncoZenge AB: OncoZenge inleder toxicitetsstudie, samt meddelar förändringar i det kliniska programmet Pressreleaser Ladda ner | Visa Stäng
2021-12-07 OncoZenge OncoZenge AB: Kommuniké från extra bolagsstämma i OncoZenge den 7 december 2021 Pressreleaser Ladda ner | Visa Stäng
2021-11-22 OncoZenge OncoZenge AB: Paul de Potocki ny VD för OncoZenge Pressreleaser Ladda ner | Visa Stäng
2021-11-22 OncoZenge Kallelse till extra bolagsstämma i OncoZenge AB (publ) Pressreleaser Ladda ner | Visa Stäng
2021-11-16 OncoZenge OncoZenge AB delårsrapport januari - september 2021 i sammandrag Rapporter Ladda ner | Visa Stäng
2021-08-17 OncoZenge OncoZenge AB delårsrapport januari - juni 2021 Rapporter Ladda ner | Visa Stäng
2021-05-25 OncoZenge OncoZenge AB: Kommuniké från OncoZenges årsstämma den 25 maj 2021 Pressreleaser Ladda ner | Visa Stäng
2021-05-18 OncoZenge OncoZenge AB: OncoZenge offentliggör delårsrapport för januari-mars 2021 Rapporter Ladda ner | Visa Stäng
2021-04-26 OncoZenge Kallelse till årsstämma i OncoZenge AB (publ) Pressreleaser Ladda ner | Visa Stäng
2021-04-12 OncoZenge OncoZenge AB: OncoZenge utser Dr. Markus Jerling till Chief Medical Officer Pressreleaser Ladda ner | Visa Stäng
2021-03-18 OncoZenge OncoZenge AB: OncoZenge meddelar sista dag för handel i BTA Pressreleaser Ladda ner | Visa Stäng
2021-03-09 OncoZenge OncoZenge AB: OncoZenges företrädesemission kraftigt övertecknad och inga emissionsgarantier har utnyttjats Pressreleaser Ladda ner | Visa Stäng
2021-02-25 OncoZenge OncoZenge AB: BioStock: OncoZenge tar upp kampen mot oral mukosit Pressreleaser Visa Stäng
2021-02-19 OncoZenge OncoZenge AB: Idag inleds teckningsperioden i OncoZenges företrädesemission Pressreleaser Ladda ner | Visa Stäng
2021-02-18 OncoZenge OncoZenge AB: BioStock: Emissionsaktuella OncoZenges vd om förberedelserna inför fas III Pressreleaser Visa Stäng
2021-02-15 OncoZenge OncoZenge AB: Sista dag för handel med rätt att erhålla teckningsrätter är idag den 15 februari 2021 Pressreleaser Ladda ner | Visa Stäng
2021-02-12 OncoZenge OncoZenge AB: Idag inleds handeln av OncoZenges aktie på Nasdaq First North Growth Market Pressreleaser Ladda ner | Visa Stäng

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15 Nov 2022 | Kvartalsrapport 2022-Q3