【4565】そーせいG 456 【MATILDA, Phase 2a Study for DLB】
■ このスレッドは過去ログ倉庫に格納されています
>>427-428
ピーターの仕事って何？
何すれば納得すんの？ 逆にピーターって就任から何をしたのだろうか
重要人が辞めてしまった事は覚えているんだか 南アフリカランド12周年
part777>>777 。◆◎｡ｏ.:O☆
銭形兄さんおめでとございます.。:゜◎::Oσ★｡∂:o゜
. ￣￣￣Ｖ￣￣ .／ 。○。∂γ:☆O◇。σ
. ∧∧ ／ ◎:.♭★:ο｡:iσ:★:◎:
(,,ﾟДﾟ)´ ☆。σ:｡: ｏ α:θｉ:ρ☆
|,つ´ 。●..ｉｏ.｡◇.: ★ 。.:
. ＿＿ ＿ ☆―――――――σ :∂ｉo☆ ゜
. ＼ し｀Ｊ￣￣￣＼
||＼ ＼
||＼||￣￣￣￣￣￣￣||￣
|| ||￣￣￣￣￣￣￣||
........... .|| || >>429
学校じゃないんだぞ 自分で考えろ 考えられないならレスすんな 子供か 今日は日中高値1734円を超える可能性は低い
だから1720円前後で買いに入るのはリスクあり >>438
バイトくん、昼から調子こきすぎー
ワロタw 相場はサーフィンと一緒
波を読み、如何に長く乗れるかがポイント 初めて投与されてから2相
投与されてないんだからやってないと同義
ヘプタレスも治験準備完了しましたってツイートしてから何日サボってるの？
またやるやる詐欺かよ やるやる詐欺で今年も言ったことをやれないのか
間もなく第2相スタートしますって言っておいて1ヶ月経ったからな
間もなくっていうのは1週間2週間の話だと思ってたがどうやら1ヶ月以上かかる話だったようだ
こんなんじゃあと3ヶ月と20日で2つ臨床入りもやるやる詐欺かなって思われて当然 次なる飛躍へ。着実な進捗と共に更なる成長の黎明期にて振るい育ちゆく相場。控える材料と共に水準訂正。笑。
成長期。予定されていた業績の急成長と共に更なる成長戦略が進展。順調なR&D・PL等の拡充・拡大の加速。笑。
・・・
※SOSEI 2018年12月期第1四半期決算：研究開発費1,826百万円(69.5％増加) 97.3%は英国活動。プラットフォーム引き続き拡充。当社グループは13品目が創薬段階、5品目が前臨床試験中、4品目(DLB患者を対象とした日本におけるMATILDA前期第Ⅱ相試験を含む)が臨床試験中。(8/9)
※ペプチドリーム 平成30年6月期決算：PAR2に対し、高い親和性と選択性を有するペプチド・アンタゴニストを同定しており、このプログラムは現在、Hit-to-Leadのステージに入っております。(8/9)
※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Locations(Add, Study Research Site):くるみクリニック: "Recruiting". (8/9update.)
※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Change Study Status: Not yet Recruiting→"Recruiting". (8/13update, Recruiting.)
※Vaccinex: Form 10-Q(SEC Filings): ”Collaboration Agreements: ”In June 2018, the Company Entered into a Research Service Agreement with Heptares Therapeutics, Ltd. to Provide Research Services to Heptares. (8/14) ※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Add, Study Research Site: 仙台西多賀病院: "Recruiting". 香川県立中央病院: "Recruiting". (8/15update)
※ClinicalTrials(NCT03316898): Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate AD: "Change, Study Status & 5 Research Site" . Study Start: "2018/9/30". (8/16update, Recruiting)
※MiNA Therapeutics: "Senior Translational Scientist": "Looking for a top Translational Scientist to help drive development of transformational RNA medicines" (Expires: 2018/10/19). MiNA’s first clinical asset has successfully completed Phase 1 and MiNA is developing a pipeline. (8/20)
※ACS National Meeting - GPCR Symposium: "Navigating structural GPCR-ligand interaction space for crafted computer-aided drug design": Chris de Graaf, Heptares. (8/21 Presented)
※MiNA Therapeutics_HP (ttps://www.minatx.com/rna-activation/): New Video: "MiNA Therapeutics - RNA Activation". (8/22up)
※欧州特許(Heptares)：Piperidin-1-YL and Azepin-1-YL Carboxylates as Muscarinic M4 Receptor Agonists. (Inventors: Takeda Cambridge & Heptares Therapeutics). (8/22公開)
※ClinicalTrials: Ultibro(Phase3): "Concept2 Inhaler: Digital Adherence System": Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging. Add, Research Site. Status Change: “Recruiting“. Actual Start: “2018/7/11". (8/27update, Recruiting)
※ClinicalTrials(NCT03381274): Phase 1b/2, Oleclumab(MEDI9447) EGFRm NSCLC Novel Combination Study. (MEDI9447 with Osimertinib or AZD4635, AZD4635 with MEDI9447). Add, Study Research Site: ”Taiwan”. (8/28update) ※厚生労働省 薬事・食品衛生審議会 医薬品第二部会：［報告］：「オラビ錠口腔用50mg (そーせい)：新規承認」再審査期間なし、承認条件なし。「添付文書(案)」(販売元：富士フイルムファーマ株式会社、製造販売元：株式会社そーせい)。(8/29)
※ClinicalTrials(NCT02740985): A Phase 1 (Ph1b Expansion Cohorts) Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies. Change, Enrollment: "208 participants”. Add, 5 Research Site. (8/29update)
※日本特許出願(Heptares)：「オレキシン受容体アンタゴニスト」(公開特許公報(特開2018-135349A)、公開日：平成30年8月30日)。(8/30up)
※大阪大学大学院連合小児発達学研究科 行動神経学・神経精神医学 (Heptares)寄附講座研究セミナー：「急性期脳卒中を対象にした症候画像連関研究」。(8/31)
※EFMC-ISMC: EFMC 2018 Young Medicinal Chemist in Industry Prize Invited Presentation: "In silico Polypolpharmacology": Giovanni Bottegoni, Heptares. (9/4 Presented)
※SOSEI：9月4日付の日本経済新聞本誌に弊社記事「3年平均の研究開発費、未来へ投資果敢に 1位、そーせいグループ新薬開発、世界から注目(NEXT1000)」が掲載されました。(9/5)
※欧州特許出願(Heptares)：CGRP Receptor Antagonists (EP3368525A1, EP3368526A1, EP3368536A1). (9/5公開) ※Cambridge Cheminformatics Meetings, University of Cambridge: Chris de Graaf, Heptares. (9/5 Presented )
※CCPBioSim Meeting: Molecular Simulations in Drug Discovery and Development: (Invited Speakers): Chris de Graaf, Heptares. (9/7 Presented)
※Heptares_HP: Changed Contact: BioPark, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AX, UK. → "Steinmetz Building, Granta Park, Great Abington, Cambridge, CB21 6DG, UK". (9/8update)
※Chris de Graaf 6時間前：10 Sep, 1st day of 7th RSC/SCI Symposium on GPCRs in Medicinal Chemistry: Congreve (Heptares Therapeutics).
・・・
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Application of structure-based drug design to peptidergic GPCRs": Miles Congreve, Heptares. (9/10(Today) 14:50 Presenting) ※Diamond Light Source: Diamond-II Workshop: MX & Soft Condensed Matter: "Drug Discovery an Industrial Perspective": Rob Cooke, Heptares. (9/11 9:35 Presenting)
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Mining structural GPCR-ligand interaction maps to navigate medicinal chemistry space": Chris de Graaf, Heptares.(9/11 10:20 Presenting).
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Shedding light on G protein bias: structures of GPCRs coupled to G proteins determined by cryo-EM and X-ray crystallography": Chris Tate, MRC LMB. (9/12 9:30 Presenting)
※EuroQSAR 2018: "Full GPCR Structure-Based Design Unmasked by Multiple Ligand X-Ray Structures, Water Networks and Grid Molecular Interaction Field Analyses - From Hit Discovery to FEP Prediction of Binding Affinities": Jonathan Mason. (9/19 9:30 Presenting)
・・・
※ClinicalTrials(NCT03244228: HTL0016878-101): Phase 1, A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878: (Estimated Study Completion: "2018/9")
※ClinicalTrials(NCT02716012: MNA-3521-011): Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): (Phase 2a: Estimated Primary Completion: "2018/9")
・・・ ※SOSEIの成長相場の動向：[株式4分割：(2018/6/27)分割比率修正済]
2010/12/30 (終値_338) ・(2010/10/15※最安値_163、2010/12/27最高値_437)
2011/12/30 (終値_318) ・(2011/_3/15※最安値_173、2011/_6/30最高値_420)
2012/12/28 (終値_522) ・(2012/_6/_6※最安値_238、2012/_9/_7最高値_742)
2013/12/30 (終値1079) ・(2013/_1/_4※最安値_513、2013/_5/_7最高値1525)
2014/_4/25 (終値_515) 売残高144800 買残高_4212800 ・(2014/_4/22最安値_464)※[成長回収期の入口]ステージへ
2015/_2/20 (終値_945) 売残高_56800 買残高_6123200 ・(2015/_3/16最安値_713)※Heptares [成功の序章ステージ]
2015/10/30 (終値1080) 売残高_45600 買残高_8871600 ・(2015/_9/24安値_888)※米国承認[次なる飛躍ステージへ]※[上抜け圏へ]
2016/_4/25 (終値5808) 売残高159200 買残高13619600 ・(2016_5/_9最高値6545)※Allergan[強気相場]
2016/_6/24 (終値3680) 売残高_42000 買残高_9944400 ・(2016/_6/24安値3240)※[強気相場解除]※[時間軸での調整局面へ]
2017/_3/31 (終値2720) 売残高_22400 買残高10487200 ・(2017/_4/_4安値2570)※[時間軸調整は順調に推移]※[振るい場・拾い場へ]
2017/_9/_8 (終値2175) 売残高__7600 買残高_8151200 ・(2017/_9/_6最安値2147)※[拾い場も順調に推移]
2018/_1/26 (終値3053) 売残高__3600 買残高_5716400 ・(1/22安値2740)※[振るいも順調に推移]
2018/_3/_9 (終値2378) 売残高_42000 買残高_7177600 ・(3/_5安値2195)※[悪地合いにて再びの拾い場へ]
2018/_3/16 (終値2268) 売残高_54000 買残高_8079600 ・(3/16安値2268)
2018/_3/23 (終値2148) 売残高_56400 買残高_8186000 ・(3/23安値2145)
2018/_3/30 (終値2205) 売残高_57600 買残高_8112000 ・(3/26安値2080)
2018/_4/_6 (終値2203) 売残高_68000 買残高_7926000 ・(4/_3安値2138)
2018/_4/13 (終値1960) 売残高_61600 買残高_8320800 ・(4/13安値1943)
2018/_4/20 (終値1820) 売残高_60400 買残高_8460800 ・(4/20安値1815)
2018/_4/27 (終値1895) 売残高_70800 買残高_8453600 ・(4/23安値1803)
2018/_5/11 (終値1760) 売残高_84800 買残高_8396800 ・(5/11安値1665)※(5/11空売り価格規制トリガー抵触)
2018/_5/18 (終値1900) 売残高_78800 買残高_8188800 ・(5/14安値1745) 2018/_5/25 (終値1793) 売残高_78000 買残高_8364400 ・(5/25安値1780)
2018/_6/_1 (終値1838) 売残高_92000 買残高_8324000 ・(5/29安値1695)
2018/_6/_8 (終値1700) 売残高104800 買残高_8714800 ・(6/_7安値1618)※(6/_5空売り価格規制トリガー抵触)
2018/_6/15 (終値1713) 売残高_92000 買残高_8482000 ・(6/11安値1703)
2018/_6/22 (終値1693) 売残高___400 買残高_8232800 ・(6/20安値1595)
2018/_6/29 (終値1784) 売残高_____0 買残高_7931600 ・(6/26安値1663)
2018/_7/_6 (終値1387) 売残高__7300 買残高_7728300 ・(7/_5安値1304)※空売り価格規制トリガー(7/2安値1584, 7/3安値1414)
2018/_7/13 (終値1412) 売残高__6800 買残高_7479600 ・(7/11安値1342)
2018/_7/20 (終値1329) 売残高_10700 買残高_7489500 ・(7/20安値1308)
2018/_7/27 (終値1422) 売残高__6600 買残高_7579800 ・(7/23安値1325)
2018/_8/_3 (終値1369) 売残高__6600 買残高_7358300 ・(8/_2安値1366)
2018/_8/10 (終値1369) 売残高__6600 買残高_7101500 ・(8/_8安値1366)
2018/_8/17 (終値1265) 売残高__6600 買残高_6960600 ・(8/16最安値1185)※[年初来安値]
2018/_8/24 (終値1539) 売残高_52700 買残高_6610900 ・(8/20安値1291)
2018/_8/31 (終値1702) 売残高_41100 買残高_6881200 ・(8/27安値1532)
2018/_9/_3 (終値1641) 5日線乖離(-2.08％) 25日線乖離(+14.50％) 75日線乖離(_+5.62％) 200日線乖離(-22.36％) (安値1626)
2018/_9/_4 (終値1757) 5日線乖離(+3.95％) 25日線乖離(+21.37％) 75日線乖離(+13.20％) 200日線乖離(-16.68％) (安値1653)
2018/_9/_5 (終値1738) 5日線乖離(+2.27％) 25日線乖離(+18.87％) 75日線乖離(+12.12％) 200日線乖離(-17.37％) (安値1736)
2018/_9/_6 (終値1693) 5日線乖離(-0.77％) 25日線乖離(+14.79％) 75日線乖離(_+9.39％) 200日線乖離(-19.28％) (安値1640)
2018/_9/_7 (終値1700) 5日線乖離(-0.34％) 25日線乖離(+14.24％) 75日線乖離(+10.02％) 200日線乖離(-18.70％) (安値1627) ・(9/3安値1626)
2018/_9/10 (終値1681) 5日線乖離(-1.91％) 25日線乖離(+12.05％) 75日線乖離(_+8.90％) 200日線乖離(-19.35％) (安値1675) 更なる成長の黎明期にて、成長戦略も順調・着実な進展で、次なる展開・進捗が楽しみですね。GC待ち。笑。 >>462
キョウモ、ドウハンデ、ギンザニ、スシクイニイキマス ※ClinicalTrials(NCT02716012: MNA-3521-011): Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): (Phase 2a: Estimated, Primary Completion: "2018/9", Study Completion: "2018/12"). (6/14update)
↓
※ClinicalTrials(NCT02716012: MNA-3521-011): Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH). (9/10update)
Study Status Change:
・Primary Completion: September 2018 [Anticipated] → "March 2019 [Anticipated]"
・Study Completion: December 2018 [Anticipated] → "December 2019 [Anticipated]" どこがうまく行ってるんだ？ホルダーの妄言も悲しいね… 医薬品開発で二、三年スケジュールが遅れるのは普通にある事だろ。
この程度で悲観的になるのがよくわからんわ。 悲観煽ってるから心配したが延期ってミナか
金かかる買収の件も先延ばしだな 延びたら上手く行ってないとかの妄言は知識ないハゲオヤジだろw 患者の経過が順調であればいいね。
副作用少なく数値の回復を見込める新薬は貴重やし MiNA Therapeutics:
・・・
※ClinicalTrials: Phase 1/2a, (OUTREACH): Change, Primary Completion: 2016-12→"2017-06", Study Completion: 2017-06→"2017-12". (2017/2/23update)
※SOSEI：MiNA社に対する3,500万英ポンド投資(25.6%株式取得)および同社買収オプション権(全株式取得)を含む投資契約の締結：プラットフォーム技術の補完、戦略M&Aによる成長戦略。(2017/5/3)
・OUTREACHフェーズ1／2a臨床試験の結果による段階的な条件付対価体系。"OUTREACHフェーズ1／2a臨床試験からの重要臨床データは、2018年中に明らかになる見込です。"
※SOSEI決算説明会：MiNA社買収のオプション権を含む投資契約：そーせいグループのパイプライン開発の加速並びに拡大、目覚ましく拡張した技術プラットフォームを創出。新たな基盤技術獲得の可能性。(2017/5/12)
：直近12-18 ヶ月の見通し：MiNA：MTL-CEBPA 進行性肝がん(HCC)を適用としたPh1/2aの臨床データ読み出し：Ph2b/3へと開発が進捗。その他の適用でMTL-CEBPAのPh1/2a臨床試験が開始。その他のsaRNAターゲットにおける前臨床試験が開始。
※ClinicalTrials: Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): "Add, 2a Protocol". Change, Primary Completion: 2017-06→"2017-09" (2017/5/24update)
※ClinicalTrials: Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): Primary Completion: 2017-09→"2018-09" Study Completion: 2017-12→"2018-12". (2017/6/14update)
※SOSEI (English)：Presentation Material as of July 2017: "For Further Growth.", "Potential to have Two Discovery Engines: StaR & SBDD (Heptares), saRNA Therapeutics (MiNA)". (2017/7/5)
・saRNA Technology offers potential for new discovery engine: RNAa represents a platform technology that can rapidly generate a portfolio of programs: "12 months from target selection to development candidate".
※MiNA Therapeutics: Announces Publication of New Pre-Clinical Data Supporting On-Target Mechanism of Action of Clinical Candidate MTL-CEBPA. (2017/9/6) ※MiNA Therapeutics: MiNA Research Team at OTS2017. "MTL-CEBPA has Efficacy in a Broad Range of Liver Disease Models and Encouraging Early Clinical Data in a Phase 1 Trial in HCC." (2017/9/22 Presented)
※MiNA Therapeutics: MiNA Research Featured as a HOT PAPER by OTS. Best Ones to Highlight Them! "Novel Therapeutic in Clinical Trials for Liver Cancer." (2017/10/23)
※MiNA Therapeutics: Innovate UK Awards Grant to "MiNA" and "LGC LINK": Exciting New Area of Research in Collaboration. Grant of up to Approximately £400,000 will Support a Two-Year. (2017/11/2)
※MiNA Therapeutics: Boehringer Ingelheim and MiNA Therapeutics to Develop Novel Treatment Approaches for Fibrotic Liver Diseases. (2017/11/8)
・"This collaboration is a recognition of our platform and expertise in liver-based diseases as well as validation from an established pharmaceutical leader in what has been an exciting year for the company."
・"This new collaboration is another sign of our ongoing commitment to patients with cardio-metabolic diseases, including NASH."
・"It will combine MiNA’s pioneering work with saRNAs with our expertise in biopharmaceutical research and development."
※SOSEI：MiNA社、Boehringer Ingelheim社と線維性肝疾患の新治療法開発でライセンス契約締結。契約一時金や研究資金に加え、最大総額307百万ユーロのマイルストンを受領予定。(2017/11/8)
・さらにMiNA社は、共同研究開発により開発された医薬品全ての販売高に応じて二桁パーセントのロイヤルティを受領する権利を有します。
※SOSEI第2四半期決算説明資料：経営資源の最適な配分を実現する戦略的フレームワーク：価値最大化の最適な実現に向けて。ビジネスハイライト：オペレーション及び経営戦略上の重要な進捗を複数実現。(2017/11/9)
・MiNA社への戦略的な投資により、将来性の高いRNA治療薬領域に参入：Boehringer Ingelheim社との提携は、MiNA社が有するsaRNA技術の高い可能性を立証。
・MiNA：提携契約・ライセンス契約をBI社と締結。MiNA社は契約一時金や研究開発資金並びに、マイルストンで最大307百万ユーロを受領する予定。(New)
※米国特許出願(MiNA)：Albumin Production and Cell Proliferation. (2017/11/9公開)
※MiNA Therapeutics: "Development and Mechanism of Small Activating RNA Targeting CEBPA, a Novel Therapeutic in Clinical Trials for Liver Cancer". (2017/12/1up) ※SOSEI (English) Presentation Material: (J.P. Morgan Healthcare Conference: 1/8): Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan indication. (1/16up)
・We are excited about the potential of saRNA therapeutics. MiNA’s recent deal with Boehringer Ingelheim further supports MiNA/saRNA’s potential.
※米国特許(MiNA)：Methods of Inducing Insulin Production. (2/6公開)
※RNA Therapeutics Conference, London: "Utilising Small Activating RNA (saRNA) for Therapeutic Opportunities": Nagy Habib, Chairman and Co-Founder, MiNA Therapeutics. Attend: Heptares. (2/21 Presented)
※欧州特許出願(MiNA)：Sarna Compositions and Methods of Use. (2/28公開)
※欧州特許出願(MiNA)：C/EBP Alpha Sarna Compositions and Methods of Use. (2/28公開)
※MiNA Therapeutics: Read about Our CEO Robert Habib in an Interview with OTS (Oligonucleotide Therapeutics Society). (3/2)
※Oncogene: "Gene activation of CEBPA using saRNA: preclinical studies of the first in human saRNA drug candidate for liver cancer" (3/7)
※MiNA Therapeutics: Small Step Up to 1st Floor at the Translation & Innovation Hub (Imperial College London White City Campus). (3/8)
※MiNA Therapeutics: Announces Publication of Pre-Clinical Data Supporting Therapeutic Potential of Clinical Candidate MTL-CEBPA in Liver Cancer and Liver Disease: Data Published in Oncogene Demonstrate Improvement of Liver Function and Increased Survival in Multiple Disease Models. (3/9)
※米国特許(MiNA)：Albumin production and cell proliferation. (4/17公開)
※米国特許出願(MiNA)：Methods of Inducing Insulin Production. (4/26公開) ※SOSEI：2018年3月期決算説明会：「戦略プランを着実に実行し2017年度は著しい進捗を達成」。MiNA Therapeuticsにおける開発は順調に進行。MTL-CEPBAの第1/2a相臨床試験の進捗は良好。MiNAの追加株式取得のオプション行使の判断のタイミングは2018年下半期。(5/10)
※TIDES: Oligonucleotide and Peptide Therapeutics 2018: "RNA Activation in NASH, Liver Failure and Hepatocellular Carcinoma": Nagy Habib, MiNA Therapeutics. (5/10 Presented)
※MiNA Therapeutics to Present Initial Results from First-in-Human MTL-CEBPA Study at the 2018 ASCO Annual Meeting. MiNA will Announce the Results Through a Press Release Following the Presentation. (5/16)
※ASGCT: "Short Activating RNAs. MTL-CEBPa has a Broad Range of Liver Disease Models and Encouraging Early Clinical Data in a Phase 1 Trial in HCC": Nagy Habib, MiNA Therapeutics. (5/18 Presented)
※SOSEI Presentation: "Sosei Group Corporation, UBS Global Healthcare Conference": Global operations and aspirations - aiming to build Japan’s first global biotech champion: Drive Global Growth Strategy. (5/21Presented, 5/22up)
・Strategic investment in saRNA technology, Exclusive option to move from 25.6% to 100% ownership at pre-determined economics: MiNA Therapeutics.
・Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan indication: MiNA Therapeutics.
※ASCO 2018: "Preliminary results of a first-in-human, first-in-class phase I study of MTL-CEBPA, a small activating RNA targeting the transcription factor C/EBP-α in patients with advanced liver cancer": MiNA Therapeutics. (6/4 Presented)
※MiNA Therapeutics Presents Initial Results from First-in-Human MTL-CEBPA Study in Advanced Liver Cancer Patients. First look at saRNA therapeutics in patients - Initial results from Phase 1 study of MTL-CEBPA in patients with liver cancer presented. (6/4)
※Robert Habib: A very promising start for saRNA medicines in patients! Looking forward to future development of MTL-CEBPA drug candidate. Dr Sarker from GSTTnhs presenting initial clinical results of MTL-CEBPA today at ASCO 2018. (6/4)
※SOSEI：MiNA Therapeuticsが進行肝がん患者を対象とするMTL-CEBPAの初めてのヒト試験の初期結果(第I相試験の中間結果)を発表：正常肝機能および肝機能障害のある患者において良好な忍容性がみられた。血液検体の解析によりRNA活性機序を実証。薬効標的への作用を確認。(6/5)
※Heptares_HP: Download Corporate Presentation: (2018.06.08 Sosei Group Corporation Corporate Presentation June 2018): "Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan indication": MiNA Therapeutics. (6/8up) ※EHA: "MTL-CEBPA, a Small Activating RNA for Intravenous Administration to Enhance C/EBPΑ Expression in Patients with Liver Cancer Shows Potential Use in Neutropenia": Choon Ping Tan, MiNA Therapeutics. (6/16 Presented)
※City of Hope: Researchers Use Nanoparticles to Test Treatment for Liver Disease. Promising Results: In the study, saRNAs aimed at upregulating CEBPA were encapsulated in SMARTICLES nanoparticles to deliver a treatment called MTL-CEBPA in multiple liver disease models. (6/25)
・In a model of advanced liver cirrhosis, MTL-CEBPA significantly reversed liver fibrosis and liver dysfunction, enhancing survival.
・MTL-CEBPA also reversed the buildup of fat in a model of nonalcoholic fatty liver disease, improved liver function and reduced tumor size in a model of primary liver cancer.
・According to Rossi, research into the precise mechanism of action in CEBPA is currently under investigation in his laboratory.
・In addition to Rossi and Habib, additional researchers from Imperial College London, Queen Mary University of London, National Taiwan University, Norwegian University of Science and Technology, the Biomedical Research Foundation of the Academy of Athens, MiNA Therapeutics and BioTD Strategies LLC collaborated on the work.
※MiNA Therapeutics_HP: Renewal. "Development Programs" (https://www.minatx.com/pipeline/) update. (7/3up) ※MiNA Therapeutics: Exited to launch our new website. Head minatx.com to learn more about small activating RNA medicines. (7/6)
※日本核酸医薬学会年会 博多：Oligonucleotide Therapeutics Societyシンポジウム："MTL-CEBPA has efficacy in a broad range of liver disease models and encouraging early clinical data in a Phase 1 trial in HCC": MiNA Therapeutics. (7/11 Presented)
※MiNA Therapeutics: MiNA research lab very happy with our new western blot machine. Cool technology that gives us better results, faster. ProteinSimple. (7/13)
※米国特許出願(MiNA)：Albumin Production and Cell Proliferation. (7/19公開)
※Imperial College London, Imperial Innovations: Graduation Ceremony of MiNA Therapeutics: "Robert Habib from MiNA Therapeutics receives the graduation award and shares company's journey since joining Imperial Incubator." (7/31) ※Oligonucleotide Therapeutics Society (OTS): The newest Paper of the Month is Gene activation of CEBPA using saRNA: preclinical studies of the first in human saRNA drug candidate for liver cancer. MiNA Therapeutics. (8/6)
※MiNA Therapeutics: "Senior Translational Scientist": "Looking for a top Translational Scientist to help drive development of transformational RNA medicines" (Expires: 2018/10/19). MiNA’s first clinical asset has successfully completed Phase 1 and MiNA is developing a pipeline. (8/20)
※MiNA Therapeutics_HP: New Video: "MiNA Therapeutics - RNA Activation" (http://minatx.com/rna-activation/#rna_section_two_video). (8/22up) ※MiNA Therapeutics: Check out our new video explaining how saRNA medicines work. (8/28)
※ClinicalTrials: Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): Phase 2a Study Status Change: Primary Completion: 2018/9→"2019/3", Study Completion: 2018/12→"2019/12". (9/10update)
・・・
※ILCA Annual Conference, London, UK: MiNA Therapeutics. (9/14-16)
※OTS(Oligonucleotide Therapeutics Society) Annual Meeting 2018: “Pre-Clinical Studies with MTL-CEBPA Demonstrate Mode of Action in Vivo and Optimal Dose Scheduling”: David Blakey, CFO, MiNA Therapeutics. (10/2 11:50 Presenting)
※BIO-Europe, Copenhagen, Denmark: MiNA Therapeutics. (11/5-7)
※AASLD Liver Meeting 2018, San Francisco: MiNA Therapeutics. (11/9-13)
※Jefferies London Healthcare Conference, London, UK: MiNA Therapeutics. (11/14-15)
・・・ ミナの増資懸念が先送り 投資した株は値下げで損失？ DLBのⅡ相開始まで発射台が低いと一瞬でも2000円タッチは厳しくなってきた感じだな
こりゃ困った・・ ピータってやつ破格の報酬貰ってるけど社長になってから何か仕事しましたっけ？？？？ 相変わらずのバカルサ（笑）
ｵｯﾍﾟｹバカルサーと冴えない爺ID:Kp5hYZ/S0でネガキャン尽くすもまるでやる気なし（笑）
ルサンチメンズ（笑） m4も9月になったのにまだ終わらないんだよね…80億の赤字出して延期じゃ資金やりくりが厳しくなるね…トホホ… 日本のバイオベンチャーの外国人社長してるけど質問ある？ >>502
図星疲れてるの？
カップルウィズハンドルも失敗してイライラしてるのはわかるけどさ、もう少し落ち着いてよ アルツのそーせいさん、午後銚子こき杉だろ。ｺﾉﾔﾛｰ ミナの懸念がなくなったから増資はしないの？ 株主の物は俺のもの ピーター >>507
お前以外は全員調子良いんじゃねーか？いつも 次なる飛躍へ。着実な進捗と共に更なる成長の黎明期にて振るい育ちゆく相場。控える材料と共に水準訂正。笑。
成長期。予定されていた業績の急成長と共に更なる成長戦略が進展。順調なR&D・PL等の拡充・拡大の加速。笑。
・・・
※SOSEI 2018年12月期第1四半期決算：研究開発費1,826百万円(69.5％増加) 97.3%は英国活動。プラットフォーム引き続き拡充。当社グループは13品目が創薬段階、5品目が前臨床試験中、4品目(DLB患者を対象とした日本におけるMATILDA前期第Ⅱ相試験を含む)が臨床試験中。(8/9)
※ペプチドリーム 平成30年6月期決算：PAR2に対し、高い親和性と選択性を有するペプチド・アンタゴニストを同定しており、このプログラムは現在、Hit-to-Leadのステージに入っております。(8/9)
※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Locations(Add, Study Research Site):くるみクリニック: "Recruiting". (8/9update.)
※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Change Study Status: Not yet Recruiting→"Recruiting". (8/13update, Recruiting.)
※Vaccinex: Form 10-Q(SEC Filings): ”Collaboration Agreements: ”In June 2018, the Company Entered into a Research Service Agreement with Heptares Therapeutics, Ltd. to Provide Research Services to Heptares. (8/14) ※ClinicalTrials(NCT03592862: HTL0018318-203): Phase 2, A Study to Assess Safety, Tolerability, and Efficacy of HTL0018318 in Patients With Dementia With Lewy Bodies (DLB). Add, Study Research Site: 仙台西多賀病院: "Recruiting". 香川県立中央病院: "Recruiting". (8/15update)
※ClinicalTrials(NCT03316898): Phase 1b, FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil±Memantine) for the Treatment of Participants with Mild to Moderate AD: "Change, Study Status & 5 Research Site" . Study Start: "2018/9/30". (8/16update, Recruiting)
※MiNA Therapeutics: "Senior Translational Scientist": "Looking for a top Translational Scientist to help drive development of transformational RNA medicines" (Expires: 2018/10/19). MiNA’s first clinical asset has successfully completed Phase 1 and MiNA is developing a pipeline. (8/20)
※ACS National Meeting - GPCR Symposium: "Navigating structural GPCR-ligand interaction space for crafted computer-aided drug design": Chris de Graaf, Heptares. (8/21 Presented)
※MiNA Therapeutics_HP (ttps://www.minatx.com/rna-activation/): New Video: "MiNA Therapeutics - RNA Activation". (8/22up)
※欧州特許(Heptares)：Piperidin-1-YL and Azepin-1-YL Carboxylates as Muscarinic M4 Receptor Agonists. (Inventors: Takeda Cambridge & Heptares Therapeutics). (8/22公開)
※ClinicalTrials: Ultibro(Phase3): "Concept2 Inhaler: Digital Adherence System": Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging. Add, Research Site. Status Change: “Recruiting“. Actual Start: “2018/7/11". (8/27update, Recruiting)
※ClinicalTrials(NCT03381274): Phase 1b/2, Oleclumab(MEDI9447) EGFRm NSCLC Novel Combination Study. (MEDI9447 with Osimertinib or AZD4635, AZD4635 with MEDI9447). Add, Study Research Site: ”Taiwan”. (8/28update) ※厚生労働省 薬事・食品衛生審議会 医薬品第二部会：［報告］：「オラビ錠口腔用50mg (そーせい)：新規承認」再審査期間なし、承認条件なし。「添付文書(案)」(販売元：富士フイルムファーマ株式会社、製造販売元：株式会社そーせい)。(8/29)
※ClinicalTrials(NCT02740985): A Phase 1 (Ph1b Expansion Cohorts) Clinical Study of AZD4635 and Durvalumab in Patients With Advanced Solid Malignancies. Change, Enrollment: "208 participants”. Add, 5 Research Site. (8/29update)
※日本特許出願(Heptares)：「オレキシン受容体アンタゴニスト」(公開特許公報(特開2018-135349A)、公開日：平成30年8月30日)。(8/30up)
※大阪大学大学院連合小児発達学研究科 行動神経学・神経精神医学 (Heptares)寄附講座研究セミナー：「急性期脳卒中を対象にした症候画像連関研究」。(8/31)
※EFMC-ISMC: EFMC 2018 Young Medicinal Chemist in Industry Prize Invited Presentation: "In silico Polypolpharmacology": Giovanni Bottegoni, Heptares. (9/4 Presented)
※SOSEI：9月4日付の日本経済新聞本誌に弊社記事「3年平均の研究開発費、未来へ投資果敢に 1位、そーせいグループ新薬開発、世界から注目(NEXT1000)」が掲載されました。(9/5)
※欧州特許出願(Heptares)：CGRP Receptor Antagonists (EP3368525A1, EP3368526A1, EP3368536A1). (9/5公開)
※Cambridge Cheminformatics Meetings, University of Cambridge: Chris de Graaf, Heptares. (9/5 Presented )
※CCPBioSim Meeting: Molecular Simulations in Drug Discovery and Development: (Invited Speakers): Chris de Graaf, Heptares. (9/7 Presented)
※Heptares_HP: Changed Contact: BioPark, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AX, UK. → "Steinmetz Building, Granta Park, Great Abington, Cambridge, CB21 6DG, UK". (9/8update)
※ClinicalTrials(NCT02716012): Phase 1/2a, First-in-Human Safety and Tolerability Study of MTL-CEBPA in Patients With Advanced Liver Cancer (OUTREACH): Phase 2a Study Status Change: Estimated, Primary Completion: "2019/3", Study Completion: "2019/12". (9/10update)
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Application of structure-based drug design to peptidergic GPCRs": Miles Congreve, Heptares. (9/10 Presentied)
※Chris de Graaf 8時間前：11 Sep, 2nd day 7th RSC/SCI Symposium GPCRs in Medicinal Chemistry: De Graaf (Heptares) . (9/10) ※Vectura Interim Results for the Six-Month Period Ending 30 June 2018: (9/11(Today) Release)
Ultibro Breezhaler, Seebri Breezhaler Utibron Neohaler Inhalation Powder and Seebri Neohaler (Novartis/Sunovion, US):
In-market performance:
・Ultibro Breezhaler and Seebri Breezhaler continue to perform well in-market with Ultibro Breezhaler sales up 11.5% CER globally in H1 2018, 21.8% on an actual basis. (CER: EU +8.8% ROW +25.1%).
・Novartis reported $299m H1 2018 sales for Ultibro Breezhaler and Seebri Breezhaler up 14% vs. H1 2017. H1 2018 sales reported by Novartis were flat vs H2 2017 following previously reported de-stocking, with Novartis noting a subsequent acceleration in reported sales in Q2 2018.
Vectura Ultibro / Seebri revenues:
・During the period, Vectura recognised £8.5m of total royalties for sales of these products, representing a 6.3% increase vs H1 2017.
・Royalties decreased by 8.6% in H1 2018 vs H2 2017 reflecting the de-stocking reported by Novartis together with a mix effect between Ultibro and Seebri given Vectura receives slightly higher royalties on Seebri, which contributes a lower proportion of total earned revenue.
・Sunovion Pharmaceuticals Inc. is continuing with US commercial support for Utibron Neohaler and Seebri Neohaler. Vectura revenues for the US remain minimal at this stage.
Novel Formulation and Device Licence Partnerships:
QVM149 (Novartis: Europe & ROW):
・QVM149 (indacaterol/glycopyrronium bromide/mometasone furoate) is a once-daily fixed dose inhaled dual bronchodilator (LABA/LAMA) and anti-inflammatory (ICS) triple therapy for asthma being developed by Novartis.
・Novartis expects the Phase III study data readout and regulatory submission in 2019 with first-to-market potential in the EU as a triple asthma treatment delivered in a dry powder inhaler device.
Anticipated Major News flow 2018 -2019:
・QVM149 Phase III results and regulatory submission: 2019.
Financial Review:
・Royalties recognised in respect of Ultibro and Seebri were £8.5m (+6.3%) (H1 2017: £8.0m). Novartis reported Ultibro net sales of $222m in H1 2018, an increase of 17% (+7% on a constant currency basis) compared to H1 2017.
・Reported Seebri net sales were $77m in H1 2018, a 7% increase on H1 2017 and a 1% decrease on a constant currency basis.
・As reported by Novartis, Ultibro performance in H1 2017 was affected by de-stocking with Novartis noting an acceleration in reported sales in Q2 2018. ・・・
※Diamond Light Source: Diamond-II Workshop: MX & Soft Condensed Matter: "Drug Discovery an Industrial Perspective": Rob Cooke, Heptares. (9/11(Today) 9:35 Presenting)
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Mining structural GPCR-ligand interaction maps to navigate medicinal chemistry space": Chris de Graaf, Heptares.(9/11(Today) 10:20 Presenting).
※SCI/RSC Symposium on GPCRs in Medicinal Chemistry: "Keynote: Shedding light on G protein bias: structures of GPCRs coupled to G proteins determined by cryo-EM and X-ray crystallography": Chris Tate, MRC LMB. (9/12 9:30 Presenting)
※EuroQSAR 2018: "Full GPCR Structure-Based Design Unmasked by Multiple Ligand X-Ray Structures, Water Networks and Grid Molecular Interaction Field Analyses - From Hit Discovery to FEP Prediction of Binding Affinities": Jonathan Mason. (9/19 9:30 Presenting)
※千里ライフサイエンスセミナー「アルツハイマー病研究の最前線」：「アルツハイマー病というcomplex diseaseをどう攻めるか：A mouse-to-human translational research」大阪大学大学院 医学系研究科 医学部講師 (寄附講座教授) 森原剛史 (9/19 11:00)
※千里ライフサイエンスセミナー「アルツハイマー病研究の最前線」：「アルツハイマー病の治療戦略に対する洞察：対症療法や他の認知症性疾患の臨床試験をモデルとして」行動神経学・神経精神医学(Heptares)寄附講座教授 森悦郎 (9/19 14:10)
※株式会社情報機構セミナー：「ペプチド原薬の製造プロセス確立までの考え方とそのポイント」JITSUBO 研究開発部 部長 山﨑貴史 (9/21 13:30-16:30)
※Rhine-Knee Regional Meeting on Structural Biology, Switzerland: "Scientific Program Keynote Speakers": Dr. Andy Dore, Heptares Therapeutics. (9/26-28)
※Next Generation Biophysics 2018, Cambridge: keynote Lecture (cryoEM): Richard Henderson, MRC LMB. (10/3)
・・・
※ClinicalTrials(NCT03244228: HTL0016878-101): Phase 1, A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878: (Estimated Study Completion: "2018/9")
・・・ ※SOSEIの成長相場の動向：[株式4分割：(2018/6/27)分割比率修正済]
2014/_4/25 (終値_515) 売残高144800 買残高_4212800 ・(2014/_4/22最安値_464)※[成長回収期の入口]ステージへ
2015/_2/20 (終値_945) 売残高_56800 買残高_6123200 ・(2015/_3/16最安値_713)※Heptares [成功の序章ステージ]
2015/10/30 (終値1080) 売残高_45600 買残高_8871600 ・(2015/_9/24安値_888)※米国承認[次なる飛躍ステージへ]※[上抜け圏へ]
2016/_4/25 (終値5808) 売残高159200 買残高13619600 ・(2016_5/_9最高値6545)※Allergan[強気相場]
2016/_6/24 (終値3680) 売残高_42000 買残高_9944400 ・(2016/_6/24安値3240)※[強気相場解除]※[時間軸での調整局面へ]
2017/_3/31 (終値2720) 売残高_22400 買残高10487200 ・(2017/_4/_4安値2570)※[時間軸調整は順調に推移]※[振るい場・拾い場へ]
2017/_9/_8 (終値2175) 売残高__7600 買残高_8151200 ・(2017/_9/_6最安値2147)※[拾い場も順調に推移]
2018/_1/26 (終値3053) 売残高__3600 買残高_5716400 ・(1/22安値2740)※[振るいも順調に推移]
2018/_3/_9 (終値2378) 売残高_42000 買残高_7177600 ・(3/_5安値2195)※[悪地合いにて再びの拾い場へ]
2018/_6/_8 (終値1700) 売残高104800 買残高_8714800 ・(6/_7安値1618)※空売り価格規制トリガー(5/11安値1665, 6/5安値1695)
2018/_7/_6 (終値1387) 売残高__7300 買残高_7728300 ・(7/_5安値1304)※空売り価格規制トリガー(7/2安値1584, 7/3安値1414)
2018/_8/17 (終値1265) 売残高__6600 買残高_6960600 ・(8/16最安値1185)※[年初来安値]
2018/_8/24 (終値1539) 売残高_52700 買残高_6610900 ・(8/20安値1291)
2018/_8/31 (終値1702) 売残高_41100 買残高_6881200 ・(8/27安値1532)
2018/_9/_7 (終値1700) 売残高_39600 買残高_7091800(+210600)※9/11up ・(9/3安値1626)
2018/_9/10 (終値1681) 5日線乖離(-1.91％) 25日線乖離(+12.05％) 75日線乖離(_+8.90％) 200日線乖離(-19.35％) (安値1675)
2018/_9/11 (終値1714) 5日線乖離(+0.52％) 25日線乖離(+13.32％) 75日線乖離(+11.07％) 200日線乖離(-17.54％) (安値1657)
更なる成長の黎明期にて、成長戦略も順調・着実な進展で、次なる展開・進捗が楽しみですね。GC待ち。笑。 ※Vectura Interim Results for the Six-Month Period Ending 30 June 2018: Presentation. (9/11(Today) Release)
"Novartis Ultibro Breezhaler continues growth and retains ex-US class leadership"
Potential Key Growth Catalysts:
・US success of Utibron dependent on 2019 uptake in insurance coverage.
・China Ultibro and Seebri approved in 2017/2018.
・Consensus 2024 Sales Ultibro /Utibron $736m , Seebri $213m.
https://www.vectura.com/download_file/force/589/181 まあウルシーがいくら売れても多少大赤字を減らす程度にしかならないんだけどね それで他のパイプラインの進捗やマイル・ロイ発生まで持ちこたえれば十分さ。 Novartis:
・・・
※Reuters Analysts Forecasts: Ultibro 2017FY(400m: +10.19%), Ultibro 2018FY(466m), Ultibro 2019FY(509m), Seebri 2017FY(149m: 0%), Seebri 2018FY(151m) , Seebri 2019FY(154m). (2017/10/19update)
※SOSEI：ウルティブロへ治療薬切り替え後のCOPD患者肺機能を有意に改善。Seretideから切り替えで肺機能が改善し、良好な忍容性を有する新データ(FLASH)が得られた。(2017/11/28)
※中国COPD新薬市場の進展：Ultibro Breezhaler、2017年5月に中国で上市申請を行い、2018年には中国市場に参入予定。来年後半以降、COPD市場全体に新たな変化が起こることが予想されます。(2017/12/8)
※中国COPDインダカテロール/グリコピロニウム化合物：輸入申請はCFDA薬物登録の進捗状況が｢承認時｣に変更、国内レビューおよび承認作業の完成に近づいています。(2017/12/12)
※ClinicalTrials: Ultibro(Phase3): "Concept2 Inhaler: Digital Adherence System": Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging: "Study Start: 2018/3/23" (2017/12/20up, "New Trial Record")
※ClinicalTrials: Phase 3, Study to Compare QVM149 and Free Triple Combination (salmeterol/ fluticasone+ tiotropium): Change, Start Date: "2018/1/15"(11/22update), Participants: 1251→"1500". (2017/12/20update)
※Vectura Presentation: Ultibro Q3 net sales, up 18% in Europe. Strong growth with FLAME data supporting strong, Ultibro evolution. QVM149 First regulatory submissions expected in 2019. (1/4)
※Ultibroは正式承認(12/28)。中国で最初に承認された二重拡張薬になる。Ultibro承認の良いニュースは中国COPD患者治療に新たな希望をもたらした。2018年に中国のCOPD治療領域が前進します！(1/9)
※ClinicalTrial: Phase 2, Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma: "Add Locations: Germany", "Change, Study Completion: 2018/4/26" (1/15update) ※Novartis Q4 & FY 2017 Results: Ultibro(China; Approved in December 2017): Q4 (120million, +26%cc), 2017FY (411million, +12%cc), Seebri: Q4 (42million, +4%cc), 2017FY (151million, +3%cc). (1/24)
※Novartis Annual Report 2017: "Ultibro, A New Version of the Breezhaler Device is being Developed that contains electronics. The First Clinical Study(12/20up) with this Inhaler is due to begin this Year in COPD." (1/24)
※SOSEI：｢シーブリおよびウルティブロ｣の2017年第4四半期(10月～12月)の業績について。サノビオン社(10月にSeebri Neohaler販売開始)。｢ウルティブロ｣中国(12月に製造販売承認を取得)。(1/24)
※Australian Government, TGA Annual Summary 2017: Registrations of Extended Uses of Already-Approved Prescription Medicines: "September 2017, Ultibro Breezhaler" (1/29up)
※大日本住友製薬第3四半期決算：北米COPD新製品群2017年度3Q実績3百万ドル(4億円)円ベース進捗率54.4%、2017年度通期予想6百万ドル(7億円)。(1/30)
※ATS(5/21), ITEM Scientists will Present: "CLAIM study: Lung deflation and improvement of cardiac end-diastolic volumes with IND/GLY reduce dyspnea and improve health status in hyperinflated COPD patients". (2/3up)
※ClinicalTrials: Phase 3, Study to Compare QVM149 and Free Triple Combination(sal/ flu+ tio): Change, Study Start: 2018/1/15→"2018/2/5", Primary Completion: 2019/3/29→"2019/6/21". (2/6update)
※ClinicalTrials: Phase 2 (NVA237 Asthma), Bronchodilator Effects and Safety of NVA237 (25 ug and 50 ug o.d.) in Asthma. Status Change: "Completed" (2018/4/16[Anticipated]→"2017/12/29 [Actual])". (2/15update) ※Lancet Respiratory Medicine: "Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM)". (2/21)
※SOSEI：ウルティブロブリーズヘラー投与治療により肺過膨張を伴うCOPD罹患患者の心臓機能及び肺機能が大幅に改善。2剤配合気管支拡張薬が心臓機能へ与える影響を調査した初めての試験(CLAIM)。(2/22)
※ClinicalTrials: Phase 2, Two Doses of QVM149 Compared to a Fixed Dose Combination of Sal/Flu in Patients with Asthma. Status Change: "Recruiting", Actual Start: "2017/5/31", Completion: "2018/8/2". (3/2update)
※ClinicalTrials: Phase 2, Two Doses of QVM149 Compared to a Fixed Dose Combination of Sal/Flu in Patients with Asthma. Patients who have used ICS and LABA combinations for asthma for at least "1 year".→"3 month". (3/6update)
※ClinicalTrials: Phase 3, Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients with Asthma. Change: Study Start"2015/2/1"[Actual], Completion "2019/6/3". (3/7update)
※ClinicalTrials: Phase 3, A Multicenter, Open-label, Single Arm, 52-week Treatment Study to Assess the Safety of QVM149 in Japanese Patients with Asthma. Primary Completion: 2018/11/6→"2018/9/18". (3/9update)
※ClinicalTrials: Phase 3, Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium. Status Change:"Recruiting", Actual Study Start: "2018/2/9" (3/12update)
※ClinicalTrials: Phase 4, Ultibro vs Spiriva Alone to Reduce Exertional Dyspnea in Patients With Moderate to Severe COPD (RED): Change, Primary Completion: "2018/5/25", Study Completion: "2018/6/16" (3/21update) ■ このスレッドは過去ログ倉庫に格納されています
