Preclinical and clinical development of a bicyclonal inhibitor anti-prosthesis as an innovative medicine used in cancer therapy (Q78864): Difference between revisions
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(Removed claim: summary (P836): Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).The aim of the project is to develop an innovative, effective and secure candidate for the medicine used in the selection of selected cancers.According to th...) |
(Created claim: summary (P836): Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The aim of the project is to develop an innovative, effective and safe candidate for medicine used in the treatment of selected solid cancers. Ac...) |
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Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The aim of the project is to develop an innovative, effective and safe candidate for medicine used in the treatment of selected solid cancers. According to WHO data, cancers form the largest group of civilisation diseases (World Cancer Report, 2014). Recent reports point to the important role of ubiquitin-proteasom (UPS) pathway, in particular the ubiquitine activating enzyme (UAE), in regulating protein production and thus in the survival of cancer cells. Inhibition of the key protein ubiquitylation enzyme may be an effective alternative to solid tumour therapies. The first UPS inhibitor to inhibit proteases is bortezomib, registered in haematological therapies. However, its side effects, intravenous route of administration and lack of efficiency in the treatment of solid tumours, force the search for alternative drugs. The project will be conducted in 10 stages, which will last a total of 45 months. The first 9 stages will include industrial research. The synthesis of the leading UAE inhibitor will be developed to the GMP scale. Analytical methods and final formulation will be developed. Also, analyses will be conducted to intensify research on the mechanism of action and looking for biomarkers to respond to therapy. In addition, ADMET, in vivo and toxicological studies were planned to confirm the efficacy and safety of the compound. In parallel, the lead relationship will be optimised in case data disqualifying him as a drug candidate. The identified biomarkers will be verified in vivo and retrospectively using tumours from patients. A test will be developed and validated to select patients for clinical trials. The final stage of the project, (English) | |||||||||||||||
Property / summary: Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The aim of the project is to develop an innovative, effective and safe candidate for medicine used in the treatment of selected solid cancers. According to WHO data, cancers form the largest group of civilisation diseases (World Cancer Report, 2014). Recent reports point to the important role of ubiquitin-proteasom (UPS) pathway, in particular the ubiquitine activating enzyme (UAE), in regulating protein production and thus in the survival of cancer cells. Inhibition of the key protein ubiquitylation enzyme may be an effective alternative to solid tumour therapies. The first UPS inhibitor to inhibit proteases is bortezomib, registered in haematological therapies. However, its side effects, intravenous route of administration and lack of efficiency in the treatment of solid tumours, force the search for alternative drugs. The project will be conducted in 10 stages, which will last a total of 45 months. The first 9 stages will include industrial research. The synthesis of the leading UAE inhibitor will be developed to the GMP scale. Analytical methods and final formulation will be developed. Also, analyses will be conducted to intensify research on the mechanism of action and looking for biomarkers to respond to therapy. In addition, ADMET, in vivo and toxicological studies were planned to confirm the efficacy and safety of the compound. In parallel, the lead relationship will be optimised in case data disqualifying him as a drug candidate. The identified biomarkers will be verified in vivo and retrospectively using tumours from patients. A test will be developed and validated to select patients for clinical trials. The final stage of the project, (English) / rank | |||||||||||||||
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Property / summary: Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The aim of the project is to develop an innovative, effective and safe candidate for medicine used in the treatment of selected solid cancers. According to WHO data, cancers form the largest group of civilisation diseases (World Cancer Report, 2014). Recent reports point to the important role of ubiquitin-proteasom (UPS) pathway, in particular the ubiquitine activating enzyme (UAE), in regulating protein production and thus in the survival of cancer cells. Inhibition of the key protein ubiquitylation enzyme may be an effective alternative to solid tumour therapies. The first UPS inhibitor to inhibit proteases is bortezomib, registered in haematological therapies. However, its side effects, intravenous route of administration and lack of efficiency in the treatment of solid tumours, force the search for alternative drugs. The project will be conducted in 10 stages, which will last a total of 45 months. The first 9 stages will include industrial research. The synthesis of the leading UAE inhibitor will be developed to the GMP scale. Analytical methods and final formulation will be developed. Also, analyses will be conducted to intensify research on the mechanism of action and looking for biomarkers to respond to therapy. In addition, ADMET, in vivo and toxicological studies were planned to confirm the efficacy and safety of the compound. In parallel, the lead relationship will be optimised in case data disqualifying him as a drug candidate. The identified biomarkers will be verified in vivo and retrospectively using tumours from patients. A test will be developed and validated to select patients for clinical trials. The final stage of the project, (English) / qualifier | |||||||||||||||
point in time: 14 October 2020
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Revision as of 10:31, 14 October 2020
Project in Poland financed by DG Regio
Language | Label | Description | Also known as |
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English | Preclinical and clinical development of a bicyclonal inhibitor anti-prosthesis as an innovative medicine used in cancer therapy |
Project in Poland financed by DG Regio |
Statements
25,646,443.69 zloty
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37,472,533.5 zloty
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68.44 percent
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8 April 2017
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31 December 2020
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CELON PHARMA S.A.
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Numer_referencyjny_programu_pomocowego: SA.41471(2015/X) Przeznaczenie_pomocy_publicznej: art. 25 rozporządzenia KE nr 651/2014 z dnia 17 czerwca 2014 r. uznające niektóre rodzaje pomocy za zgodne z rynkiem wewnętrznym w stosowaniu art. 107 i 108 Traktatu (Dz. Urz. UE L 187/1 z 26.06.2014). Celem projektu jest opracowanie innowacyjnego, skutecznego i bezpiecznego kandydata na lek, stosowanego w terapii wybranych nowotworów litych. Zgodnie z danymi WHO, nowotwory tworzą największą grupę chorób cywilizacyjnych (World Cancer Report, 2014). Ostatnie doniesienia wskazują na istotną rolę ścieżki ubikwityna-proteasom (UPS), w szczególności enzymu aktywującego ubikwitynę (UAE), w regulacji produkcji białek, a tym samym w przeżywaniu komórek nowotworowych. Hamowanie kluczowego enzymu ubikwitylacji białek może stanowić skuteczną alternatywę w terapiach guzów litych. Pierwszym inhibitorem UPS, hamującym proteasom, jest bortezomib, zarejestrowany w terapiach hematologicznych. Jednak jego efekty uboczne, dożylna droga podania oraz brak efektywności w leczeniu guzów litych, wymusza szukanie alternatywnych leków. Projekt będzie prowadzony w 10 etapach, które łącznie będą trwać 45 miesięcy. Pierwsze 9 etapów obejmie badania przemysłowe. Synteza wiodącego, uzyskanego inhibitora UAE, zostanie opracowana do skali GMP. Zostaną opracowane metody analityczne i ostateczna postać leku. Również, prowadzone będą analizy pogłębiające badania mechanizmu działania oraz poszukujące biomarkerów odpowiedzi na terapię. Ponadto, zaplanowano badania ADMET, in vivo i toksykologiczne, w celu potwierdzenia efektywności i bezpieczeństwa związku. Równolegle, związek wiodący będzie optymalizowany, na wypadek pojawienia się danych dyskwalifikujących go jako kandydata na lek. Zidentyfikowane biomarkery zostaną zweryfikowane in vivo i retrospektywnie, z wykorzystaniem guzów pochodzących od pacjentów. Zostanie opracowany i zwalidowany test do selekcji pacjentów do badań klinicznych. Ostatnim etapem projektu, (Polish)
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Reference number of the aid programme: SA.41471(2015/X) Purpose of public aid: Article 25 of EC Regulation No 651/2014 of 17 June 2014 declaring certain types of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty (OJ L. I'm sorry. EU L 187/1 of 26.06.2014). The aim of the project is to develop an innovative, effective and safe candidate for medicine used in the treatment of selected solid cancers. According to WHO data, cancers form the largest group of civilisation diseases (World Cancer Report, 2014). Recent reports point to the important role of ubiquitin-proteasom (UPS) pathway, in particular the ubiquitine activating enzyme (UAE), in regulating protein production and thus in the survival of cancer cells. Inhibition of the key protein ubiquitylation enzyme may be an effective alternative to solid tumour therapies. The first UPS inhibitor to inhibit proteases is bortezomib, registered in haematological therapies. However, its side effects, intravenous route of administration and lack of efficiency in the treatment of solid tumours, force the search for alternative drugs. The project will be conducted in 10 stages, which will last a total of 45 months. The first 9 stages will include industrial research. The synthesis of the leading UAE inhibitor will be developed to the GMP scale. Analytical methods and final formulation will be developed. Also, analyses will be conducted to intensify research on the mechanism of action and looking for biomarkers to respond to therapy. In addition, ADMET, in vivo and toxicological studies were planned to confirm the efficacy and safety of the compound. In parallel, the lead relationship will be optimised in case data disqualifying him as a drug candidate. The identified biomarkers will be verified in vivo and retrospectively using tumours from patients. A test will be developed and validated to select patients for clinical trials. The final stage of the project, (English)
14 October 2020
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Identifiers
POIR.01.02.00-00-0009/17
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