杏國乳癌新藥，比利時三期臨床獲准 2014-02-05 14:57 時報資訊 【時報-台北電】 杏國(4192)用於治療三陰性乳癌(Triple-negative Breast Cancer, TNBC)的新藥EndoTAG-1，再報佳音!該新藥2月4日接獲比利時藥品與保健食品主管機關(FAMHP)獲准在比利時進行三期臨床。杏國是在去年5月間，以240.58萬歐元(約新台幣9,400萬元)，取得德國新藥研發公司MG(Medi Gene)6.09％股權，成為該公司最大法人股東，並取得新藥EndoTAG-1全球三期臨床試驗全適應症的主導權，該案也開啟本土新藥公司入股德國上市藥廠先例。 專注於新藥研發的杏國，手中有4個新藥研發中，除了EndoTAG-1外，SB01和SB02是技轉國家衛生研究院抗癌新穎小分子新藥。而SB04則用於治療乾式老年性黃斑部病變，技術來源為美國 Mac uCLEAR新藥研發公司，杏國是以100萬美元入股Mac uCLEAR，雙方合作在美國和台灣進行二/三期臨床。 杏國表示，SB01和是SB02國人自行研發的原創型新藥，目前SB01已進行一期臨床，SB02則規劃2016年將執行第一期臨床試驗，該專案並於去年6月獲得歐洲專利。(新聞來源：工商即時 杜蕙蓉)
Medigene Announces Results from Investigator Initiated Trial of EndoTAG-1 to be Published for ASCO 2013 (Ref: Medigene)April 12th, 2013 Martinsried/Munich, April 11, 2013. Medigene AG (Frankfurt, Prime Standard; MDG) announced today that the results from the Phase 2 investigator initiated trial (IIT) of EndoTAG®-1 in HER2-negative breast cancer will be published for the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO). The abstract (#114428), entitled "Feasibility study of cationic liposome-encapsulated paclitaxel in combination with paclitaxel followed by FEC as induction therapy in HER2-negative breast cancer" was chosen for inclusion online in the ASCO 2013 Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, and will be released at www.asco.org on May 15, 2013.
ENDOTAG-1®, A CATIONIC LIPOSOMECONTAINING PACLITAXEL, DEMONSTRATES ANTI-ANGIOGENIC AND ANTI-INFLAMMATORY ACTIVITY IN RHEUMATOID ARTHRITIS IN VIVO
Introduction: Inflammation and angiogenesis are hallmarks of rheumatoid arthritis (RA) that contribute largely to the formation of pannus tissue and joint destruction in patients suffering from RA. We have recently shown that intravenously applied cationic liposomes target efficiently angiogenic endothelial cells in the synovial vasculature of rheumatoid joints and therefore may also serve as potent vehicles for systemic drug delivery and therapy in RA. Therefore the aim of our study was to quantify the antiangiogenic and antiinflammatory properties of EndoTAG-1® (paclitaxel formulated in cationic liposomes) in the inflamed joints of murine models of RA and to compare the therapeutical efficacy of EndoTAG-1® to Taxol® (paclitaxel in Cremophor EL).
Materials and Methods: Targeting of fluorescently labelled cationic liposomes to the synovial vasculature in mice with antigen-induced arthritis (AIA) was analysed by intravital microscopy. Density of functional vessels and adhesion of fluorescently labelled platelets or leukocytes were determined after treatment with EndoTAG-1®. Knees were subjected to clinical scoring and histopathological analysis.
Results: EndoTAG-1® treatment of AIA mice with developing or in established disease showed a strong attenuation of the course of the disease as well as a potent anti-inflammatory effect. Histological analysis of knee sections demonstrated a dramatic reduction of the pannus and infiltration of inflammatory cells. Enrichment of EndoTAG at the synovial vasculature of AIA mice was observed when compared with healthy mice. Treatment of AIA mice with EndoTAG-1® concomitant to disease induction showed a complete remission of the course of the disease as shown by a significant decrease of clinical scores compared to both control and Taxol® treated groups. A complete inhibition (98%) of neo-vascularisation was observed in the synovial vasculature of mice with AIA that were treated with EndoTAG-1® whereas Taxol® alone showed only 50% inhibitory effect. Rolling and adhesion of platelets were reduced to 53% (paclitaxel 5%) and 98% (paclitaxel 57%), respectively.
Discussion: Our in vivo data clearly demonstrates that anti-angiogenic and anti-inflammatory activity of Endo-TAG-1® contribute to the therapeutical efficacy of this drug in RA. Notably, therapeutic efficacy with Endo-TAG-1® was superior to Taxol®. This strongly suggests that systemic delivery of cationic liposomes is very well suited to enrich compounds to rheumatoid joints for therapy and could be a promising treatment option for RA.
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