ライフサイエンスコーパス: clinical development

1 screen through selection of tazemetostat for clinical development.

2 omising genome editing approaches for future clinical development.

3 ic intervention or are in advanced stages of clinical development.

4 V), and influenza, are increasingly entering clinical development.

5 6 (BMS-935177) was selected to advance into clinical development.

6 nes that inhibit CETP and raise HDL-C are in clinical development.

7 cies are in various stages of preclinical or clinical development.

8 er classes of LDL-lowering therapies, are in clinical development.

9 gree of protection and should be advanced in clinical development.

10 tion of 8 identified 8.H3PO4 as suitable for clinical development.

11 reas promising new targeted agents are under clinical development.

12 promising first-in-class drug candidate for clinical development.

13 impact of an NDV outbreak have precluded its clinical development.

14 a noncatalytic antidote that is currently in clinical development.

15 (FE 203799) was selected as a candidate for clinical development.

16 s an area in which biomarkers are needed for clinical development.

17 idine-based DHODH inhibitor 1 (DSM265) is in clinical development.

18 findings from our study will accelerate its clinical development.

19 ates and Europe and agents in late stages of clinical development.

20 der various stages of active preclinical and clinical development.

21 investigation for use in several vaccines in clinical development.

22 monoclonal antibodies in advanced stages of clinical development.

23 Multiple HDM2 antagonists are currently in clinical development.

24 ncy and is a promising candidate for further clinical development.

25 generation PS ASOs are at various stages of clinical development.

26 evels of GMP compliance at earlier stages of clinical development.

27 0s, including several in late preclinical or clinical development.

28 small-molecule drug targeting GSTO1 is under clinical development.

29 incorporated into an ADC that is in phase I clinical development.

30 s no longer classified as a select agent for clinical development.

31 ic for TF-directed therapies currently under clinical development.

32 ing nanoparticle formulation to proceed into clinical development.

33 er for responsiveness to STAT3 inhibitors in clinical development.

34 e of these candidates are in a late stage of clinical development.

35 nization and testing of these antibodies for clinical development.

36 /ml and 50 000 AUeq/ml strengths for further clinical development.

37 PI3K inhibitors have been approved or are in clinical development.

38 ted targets could double the success rate in clinical development.

39 erapeutic use and hundreds more currently in clinical development.

40 ns for TAM antagonists that are currently in clinical development.

41 y and ultimately the selection of CC-223 for clinical development.

42 tiviral drugs that are in the late stages of clinical development.

43 hat are in various stages of preclinical and clinical development.

44 ase (PI3K)-delta/gamma isoforms currently in clinical development.

45 1 and/or ALK inhibitors at various levels of clinical development.

46 uld make the RP2 gene therapy attractive for clinical development.

47 the 3-mg/kg dose (n = 37) chosen for further clinical development.

48 ounded pharmacological target validation and clinical development.

49 with a GBS conjugate vaccine currently under clinical development.

50 work resulted in the selection of CC-115 for clinical development.

51 lucocorticoids, anthracyclines and agents in clinical development.

52 malaria in combination with other agents in clinical development.

53 on platforms used to create ADC currently in clinical development.

54 ammalian target of rapamycin) pathway are in clinical development.

55 inical candidate and is currently in phase 1 clinical development.

56 flexibility and efficiency in pharmaceutical/clinical development.

57 nhibitors, some of which progressed to early clinical development.

58 consider when evaluating bNAb candidates for clinical development.

59 llular toxicity, which prevents their use in clinical development.

60 a small-molecule CDK6 inhibitor currently in clinical development.

61 promising class of antiretroviral agents for clinical development.

62 se cholesterol transport, are in early-stage clinical development.

63 foliglurax) was nominated as a candidate for clinical development.

64 DNA, siRNA, or aptamers for preclinical and clinical development.

65 omarigliptin, which is currently in phase 3 clinical development.

66 become integral in antiviral combinations in clinical development.

67 ory AML and have informed subsequent phase 2 clinical development.

68 and a peptidomimetic that have entered full clinical development.

69 studies in man, it was later withdrawn from clinical development.

70 otein kinase activator currently in Phase 2b clinical development.

71 ld nanoparticles, broadening the options for clinical development.

72 by use of structural information that are in clinical development.

73 tion presents additional challenges to their clinical development.

74 trials can be used to improve pediatric SLIT clinical development.

75 be safe and immunogenic and is available for clinical development.

76 ass" small-molecule LOXL2 inhibitor to enter clinical development.

77 y low oral bioavailability limit its further clinical development.

78 in clinical trials, with many others in pre-clinical development.

79 duction is complex and poses an obstacle for clinical development.

80 tion of JNJ-54175446 (14) as a candidate for clinical development.

81 therapeutic approaches based on this are in clinical development.

82 clinical trials, and many more are in early clinical development.

83 ing cancer, and several MT inhibitors are in clinical development.

84 ld be considered for further preclinical and clinical development.

85 rapeutic use of the pertinent antagonists in clinical development.

86 e discuss emerging LDL-lowering therapies in clinical development.

87 ber of small molecule inhibitors in oncology clinical development across multiple disease indications

88 and illustrates therapies in preclinical and clinical development against CLL.

89 se inhibitor, VS-4718, which is currently in clinical development, also drives depletion of Tregs and

90 EZH2-mutated lymphomas and are currently in clinical development, although the molecular basis of in

91 ible and drug-resistant strains have entered clinical development and are either in various phases of

92 PI3Kalpha inhibitors are in clinical development and despite promising early clinica

93 cardiotoxicity, thus encouraging its further clinical development and evaluation.

94 iew of the regulatory considerations for the clinical development and licensure of Zika vaccine candi

95 For the continuing clinical development and long-term success of theranosti

96 p21-activated kinase (PAK) are in late-stage clinical development and might impede oncogenic signalin

97 K inhibitors, and we provide an outlook into clinical development and open questions regarding BTK in

98 review is to give a basic overview of OVs in clinical development and provide a description of the cu

99 predictors to be integrated into subsequent clinical development and provide mechanistic insights in

100 study is to identify biomarkers for further clinical development and to yield insights into the path

101 tors resulting in several compounds entering clinical development and two FDA approved NMEs.

102 nvened the Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecular

103 In this Review, we discuss clinical developments and controversies in the treatment

104 drug candidate has recently entered phase 1 clinical development, and has further indicated potentia

105 been recently approved or are in late-stage clinical development, and new delivery modalities in cel

106 ansfer protein inhibitors, are in late-stage clinical development, and other approaches that promote

107 ther oncologic indications, agents in active clinical development, and others with promising preclini

108 ing therapeutic approaches are now under pre-clinical development, and recent clinical trials have ev

109 partnerships for pharmaceutical development, clinical development, and regulatory submission.

110 ells and low-dose CD3 Abs, both currently in clinical development, and that act in synergy to control

111 ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting f

112 The majority of vaccine candidates in clinical development are highly purified proteins and pe

113 considered potentially suitable for further clinical development, are presented in this report; data

114 a refined analog of diazonamide A slated for clinical development as a cancer therapeutic.

115 JR11 is under clinical development as a PET imaging agent when labeled

116 MEAN is a promising candidate for clinical development as a single-agent therapy or in com

117 The candidate is well positioned for clinical development as an oncolytic virus.

118 lead molecules have the potential for future clinical development as novel therapeutics in the treatm

119 Danoprevir (compound 49) was selected as the clinical development candidate for its favorable potency

120 phosphate loading led to identification of a clinical development candidate GS-6620.

121 SC81458 and the clinical development candidate, SC83288, are fast-acting

122 The data merit 83 as a clinical development candidate.

123 r once-weekly human dosing and selected as a clinical development candidate.

124 glucagon-like peptide-1 (GLP-1) analogue in clinical development, compared with insulin glargine in

125 We provide an update on PARP inhibitor clinical development, describe recent advances in our un

126 ce marine-derived natural product that is in clinical development directed at HIV/AIDS eradication, c

127 entinel case in a phase II study that led to clinical development discontinuation for BMS-986094, an

128 PI3Kalpha inhibitors, now in late-stage clinical development, elicit a robust compensatory incre

129 Over a quarter of drugs that enter clinical development fail because they are ineffective.

130 ther indications, with four candidates under clinical development for attention deficit hyperactivity

131 ponses to a variety of vaccine Ags and is in clinical development for both infectious diseases and ca

132 , there are vaccine candidates in late-stage clinical development for C. difficile, S. aureus, and P.

133 Although TOR-KIs are in clinical development for cancer, their effects on mature

134 s and implantable devices, have been used in clinical development for diseases such as diabetes and i

135 ta (PI3K-delta) and PI3K-gamma in late-stage clinical development for hematologic malignancy treatmen

136 Liver-derived stem cells are in clinical development for inborn and acquired liver disea

137 With one drug already in clinical development for patients with multiple sclerosi

138 rker analyses demonstrates the potential for clinical development for personalized treatment.

139 erent plasma donors, and support its further clinical development for prevention of liver graft infec

140 excellent candidates for further preclinical/clinical development for prophylactic and therapeutic ap

141 CC-220 (compound 6), a cereblon modulator in clinical development for systemic lupus erythematosis an

142 inhibiting dye shows promise for further pre-clinical development for targeting high risk AML.

143 BTK kinase inhibitor ibrutinib, which is in clinical development for the treatment of ABC DLBCL, syn

144 have both undergone preclinical and Phase II clinical development for the treatment of AD.

145 of IAP proteins that is currently undergoing clinical development for the treatment of cancer.

146 antigen of prostate 1 (STEAP1) are in early clinical development for the treatment of castration-res

147 MK-7655, in combination with imipenem, is in clinical development for the treatment of infections cau

148 afety profile, 4 (mavatrep) was selected for clinical development for the treatment of pain.

149 mic properties of merestinib and support its clinical development for the treatment of patients with

150 DAS181, an inhaled sialidase, is undergoing clinical development for the treatment of PIV in adults

151 Compound 57 (FE 202767) is currently in clinical development for the treatment of preterm mother

152 novel, irreversible proteasome inhibitor in clinical development for the treatment of relapsed or re

153 a fourth-generation cephalosporin, is under clinical development for the treatment of serious Gram-n

154 f whom survived, and is currently in Phase 2 clinical development for treatment of Ebola virus diseas

155 vir is a novel helicase-primase inhibitor in clinical development for treatment of herpes simplex vir

156 ctive inhibitor of late INa, is currently in clinical development for treatment of long QT-3 syndrome

157 In addition, several miRs are in clinical development for various diseases.

158 bitors, some of which are in clinical use or clinical development for various pathologies, among whic

159 neral principles guiding the nonclinical and clinical development for Zika vaccines are the same as t

160 al antibody-drug conjugates, are in advanced clinical development, forming an important part of the m

161 we optimized the ADCC-enhanced molecule for clinical development, generating an antibody (ARGX-111)

162 However, their clinical development has been hindered by the lack of a

163 otides are not a new concept, but successful clinical development has proceeded at a slow pace.

164 Tazemetostat, an EHZ2 inhibitor in clinical development, has shown activity in both preclin

165 hat several kinase inhibitors approved or in clinical development have AXL as either a prominent seco

166 ic monoclonal antibody KTN3379, currently in clinical development in human cancer patients, in comple

167 e, which has successfully completed phase II clinical development in men with castration resistant (a

168 S1P1 modulator that is currently in advanced clinical development in multiple sclerosis, was equipote

169 We also discuss the current status of AAV clinical development in oncology and future directions f

170 f BYL719, a PI3Kalpha inhibitor currently in clinical development in solid tumours.

171 eir limited ability to predict their fate in clinical development, including due to design flaws and

172 ntreated advanced melanoma led to subsequent clinical development, including randomized trials.

173 in multiple solid tumors and support further clinical development, investigation, and application of

174 g a purine-scaffold HSP90 inhibitor in early clinical development is an effective therapeutic approac

175 alaria vaccine candidates in preclinical and clinical development is limited.

176 as promising antitumour activity and further clinical development is warranted in patients with advan

177 Further clinical development is warranted.

178 ients, at specialized centers, or is further clinical development justified, with the aim of offering

179 they often suffer from manufacturability and clinical development limitations such as instability and

180 uggest that EZH2 enzymatic inhibitors now in clinical development may not fully suppress the oncogeni

181 ble to a neutralizing monoclonal antibody in clinical development (MEDI4893).

182 umber of Hsp90 inhibitors are in preclinical/clinical development, none strongly differentiate betwee

183 (225) Ac chelation that will facilitate the clinical development of (225) Ac TAT for the treatment o

184 d providing the molecular basis to guide pre-clinical development of 3E10 as an anti-cancer agent.

185 Clinical development of a mesogenic strain of Newcastle

186 preclinical results pave the way for further clinical development of alphavbeta6 antagonists for pros

187 o exploit vulnerabilities and may facilitate clinical development of ALT detection assays and persona

188 a preclinical mechanistic rationale for the clinical development of Axl inhibitors to improve the tr

189 a preclinical mechanistic rationale for the clinical development of AXL inhibitors to improve the tr

190 findings provide a mechanistic basis for the clinical development of BET protein inhibitors in ABC DL

191 effects posing significant challenges to the clinical development of CDK8/19 inhibitors.

192 variable, but their manifestation slowed the clinical development of cell replacement therapies.

193 primate models will be an important step in clinical development of cell therapy.

194 The clinical development of checkpoint inhibitor-based immun

195 portant insights with respect to the further clinical development of checkpoint inhibitors.

196 Clinical development of Chk1 inhibitors is currently foc

197 Herein, we review the clinical development of CTLA-4-, PD-1-, and PD-L1-blocki

198 The clinical development of drug combinations is typically a

199 Our findings should be considered in the clinical development of drugs targeting the cytochrome b

200 Information collected during the clinical development of ecallantide for treatment of acu

201 ortant characteristics to monitor during the clinical development of emerging vaccine technologies.

202 Clinical development of fedratinib was subsequently disc

203 rasitic strains, as attested by the phase II clinical development of ferroquine, with a new framework

204 hibition of PI3K and provide a rationale for clinical development of GDC-0941 in myeloma.

205 very of powerful genetic targets has spurred clinical development of gene therapy approaches to treat

206 The discovery, characterization, and clinical development of glucagon-like-peptide-1 (GLP-1)

207 g that these results will be relevant to the clinical development of glutamine metabolism inhibitors

208 These results support the clinical development of hESC-derived therapy, combined w

209 s a central and controversial unknown in the clinical development of immunotherapeutics.

210 olving crosspriming and CD8 T cells advocate clinical development of immunotherapy combinations with

211 he safety and tolerability support continued clinical development of ISIS-APO(a)Rx as a potential the

212 These findings have informed the subsequent clinical development of ixazomib in multiple myeloma.

213 finding provides a mechanistic basis for the clinical development of JNK inhibitors in DLBCL, ideally

214 To support clinical development of LRRK2 inhibitors as disease-modi

215 Herein, we report the nonclinical and early clinical development of LY2886721, a BACE1 active site i

216 ings provide a preclinical rationale for the clinical development of MALT1 inhibitors in CLL, in part

217 oof of concept study designed to support the clinical development of mass spectrometry imaging (MSI)

218 fy pharmacodynamic biomarkers to support the clinical development of MCT inhibitors now in clinical t

219 However, clinical development of metronomic chemotherapy has been

220 ce on the radiological appearance as well as clinical development of MS in patients with LHON.

221 recognized as an important step in the (pre)clinical development of nanomedicines.

222 However, clinical development of nanoparticles is challenging bec

223 safety, and efficacy profiles accompany pre-clinical development of nanotechnology-formulated drugs.

224 The clinical development of neuropeptides has been limited b

225 ysiological basis, mechanisms of action, and clinical development of novel pharmacological strategies

226 unique genomic signature that can guide the clinical development of ON123300.

227 Clinical development of OVs is increasingly focused on t

228 ese data support the further preclinical and clinical development of prophylactic HSV-2 vaccines that

229 These data support the clinical development of QGE031 as a treatment of asthma.

230 ic prompted worldwide partners to accelerate clinical development of replication-defective chimpanzee

231 sk of abnormalities in iPSCs and will inform clinical development of reprogramming technology.

232 Results support further clinical development of rhPDGF-BB for patients with PD.

233 us viruses, resulting in the preclinical and clinical development of RNA interference (RNAi) therapeu

234 action and a distinct chemotype support the clinical development of SC83288, as an intravenous appli

235 nsitivity that should be explored during the clinical development of SN30000, TH-302, and other hypox

236 atrial fibrillation to pave the way for the clinical development of stratified atrial fibrillation t

237 physiological LRRK2 substrates has hampered clinical development of such therapeutics.

238 implications for prognostication, the future clinical development of targeted agents, and disease man

239 tive NFT ligands, and recent progress in the clinical development of tau PET radioligands.

240 his observation has led to the discovery and clinical development of therapy targeting the CSF1 recep

241 h efficacy in this macaque model support the clinical development of these gel formulations for preve

242 re directions in the further preclinical and clinical development of these new anticancer drugs are a

243 rovide a reliable biomarker to accompany the clinical development of these novel therapeutic interven

244 ity of N6-LS in vivo, supporting the further clinical development of this antibody.IMPORTANCE Monoclo

245 These data support further clinical development of this candidate vaccine.

246 st and have significant implications for the clinical development of this class of molecules.

247 re believed to play an important role in the clinical development of this disease.

248 These results support further clinical development of this nonviral gene therapy appro

249 These findings support continued clinical development of this potential therapeutic vacci

250 prior data) from trials conducted during the clinical development of timothy grass SLIT-tablets.

251 ation, and provide preclinical rationale for clinical development of TMP in WM alone or in combinatio

252 However, clinical development of TNKS-specific PARP catalytic inh

253 The clinical development of triptolide over the past two dec

254 ctive biomarkers are needed for the rational clinical development of tumour vascular-disrupting drugs

255 Despite initial signs of efficacy, clinical development of urelumab has been hampered by in

256 This study bolsters support for the clinical development of UV-4B as an antiviral drug again

257 ill be a particularly useful platform in the clinical development of viral vectors expressing problem

258 These data support the rapid clinical development of ZIKV vaccines for humans.

259 ment of bone metastases and with the ongoing clinical development of, among others, (177)Lu-dodecanet

260 tudy, we analyze the causes of one hurdle to clinical development, off-target reactivity, or nonspeci

261 lecule drugs directed at the family entering clinical development, only two compounds have reached th

262 are used as a regulatory tool for dialog on clinical development or manufacturing plans.

263 attenuating mutations used previously in the clinical development pathway of an rVSV/human immunodefi

264 somiasis vaccines in different phases of the clinical development pipeline and highlight the Sm-p80-b

265 The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in In

266 opment and should be an integral part of the clinical development plan, rather than studied after reg

267 from both preclinical studies and the GLP-2 clinical development program for short bowel syndrome (S

268 how evidence generated from the mepolizumab clinical development program showed that blood eosinophi

269 migraine, thus supporting advancement of the clinical development programme to phase 3 clinical trial

270 g efficacy on exacerbations are done late in clinical development programmes.

271 reatment, and accelerate the productivity of clinical development programmes.

272 Finally, regulatory reform is needed so that clinical development programs are feasible, rigorous, an

273 ble-blind, placebo-controlled trials for the clinical development programs of selected allergic rhini

274 or predictive biomarker testing was based on clinical development restricted to biomarker-positive pa

275 nd base analogs that are FDA-approved and in clinical development since 2000.

276 phosphonate nucleoside prodrugs that entered clinical development, some of which may in the future be

277 antibodies (mAbs) to clearly determine early clinical development strategies for this class of compou

278 Nevertheless, definition of clinical development strategies to enable sound regulato

279 tion in vivo by specific Hsp90 inhibitors in clinical development, tanespimycin (17-(allylamino)-17-d

280 allosteric ABL1 inhibitor that is undergoing clinical development testing in patients with CML and Ph

281 ug, the orotomides, is an antifungal drug in clinical development that demonstrates excellent potency

282 k and the ban of hydroxamate inhibitors from clinical development, the discovery of non-hydroxamate m

283 With antagonists in clinical development, these findings may help to allevia

284 NI candidates that have entered clinical development thus far have all been N-nucleoside

285 Their clinical development thus provides a new approach to tre

286 by providing realistic estimates for lengthy clinical development timelines and positioning current r

287 ng of compounds from research stages through clinical development to market is provided through the i

288 the two H5 pLAIV candidates are suitable for clinical development to protect humans from infection wi

289 in the early (discovery-level) phase of pre-clinical development to summarize common challenges in t

290 Sclerostin antibodies are under clinical development to treat osteoporosis and metastati

291 The progress from clinical development towards product licensure of severa

292 e used to guide selection of TBVs for future clinical development using the viral-vectored delivery p

293 quently considered as its "ancestor" and OBZ clinical development was justified by the importance of

294 d anticancer drugs or compounds currently in clinical development, we set out to identify novel effec

295 III) therapies for hemophilia A have been in clinical development, which aim to increase the half-lif

296 continue to stimulate important research and clinical development, which, in turn, shapes the current

297 tion of their performance in preclinical and clinical development will require appropriate neutraliza

298 The ProTide 6f is now in clinical development with encouraging efficacy signals i

299 linic or currently under active research and clinical development, with particular emphasis on their

300 cal therapy trials are at the early stage of clinical development, with the majority still being phas