Delving into the Latest Updates on Alfatide[18F] with Synapse

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals

Synonyms

(18)F-AlF-NOTA-PRGD2, 18F-AlF-NOTAE[PEG4-c(RGDfk)]2, 18F-Alfatide II

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Target

αvβ3

Mechanism

αvβ3 antagonists(Integrin alpha-V/beta-3 antagonists)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Non-Small Cell Lung Cancer

Inactive Indication-

Originator Organization

Jiangsu Shimeikang Pharmaceutical Co. Ltd.

Active Organization

Jiangsu Shimeikang Pharmaceutical Co. Ltd.

Yantai Lannacheng Biotechnology Co., Ltd.

Taizhou Qirui Pharmaceutical Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC93H146AlFN24O31

InChIKeyWUGBBIVPEQZTOB-LKQFREDSSA-K

CAS Registry-

Sequence Code 1507071

This is a multicenter, open, non-inferiority Phase III clinical study to evaluate the efficacy of 18F-Alfatide Injection PET/CT compared with 18F-FDG PET/CT in the diagnosis of lymph node metastasis in non-small cell lung cancer.
This trial will include 428 patients with non-small cell lung cancer confirmed by imaging, histopathology and/or cytology or highly suspected by investigators, suspected lymph node metastasis and proposed radical surgery and lymph node dissection. Eligible subjects will receive 18F-Alfatide Injection PET/CT and 18F-FDG PET/CT scans within 1 week. Subjects will undergo relevant security checks before and after each scan. The subjects underwent radical surgery and lymph node dissection within 2 weeks of completing both scans, and the obtained lymph nodes were pathologically examined as the gold standard to compare the diagnostic efficacy of 18F-Alfatide versus 18F-FDG for lymph node metastasis.

Start Date01 Aug 2024

Sponsor / Collaborator

Yantai Lannacheng Biotechnology Co., Ltd.

ChiCTR2100047602

/ RecruitingEarly Phase 1IIT

11C- MET and 18F-Alfatide II dual-tracer PET/MR molecular imaging in differential diagnosis of radiation-induced brain injury and glioma recurrence

Start Date17 Jun 2021

Sponsor / Collaborator-

CTR20192146

/ CompletedPhase 1

一项观察氟[18F]阿法肽注射液在中国健康成年受试者体内的安全性、药代动力学特征以及生物分布的临床研究

[Translation] A clinical study to observe the safety, pharmacokinetic characteristics and biodistribution of 18F-fluoro[18F]alfatide injection in healthy Chinese adult subjects

主要目的：观察氟[18F]阿法肽注射液在中国健康成年受试者中单次注射的安全性及耐受性。次要目的：评价氟[18F]阿法肽注射液在中国健康成年受试者中单次注射的药代动力学（PK）特征；评估氟[18F]阿法肽注射液在中国健康成年受试者体内放射性分布特征及辐射暴露量。

[Translation]

Primary objective: To observe the safety and tolerability of a single injection of fluoro[18F] alpha peptide injection in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of a single injection of fluoro[18F] alpha peptide injection in healthy Chinese adult subjects; To assess the radioactivity distribution characteristics and radiation exposure of fluoro[18F] alpha peptide injection in healthy Chinese adult subjects.

Start Date07 Nov 2019

Sponsor / Collaborator

Taizhou Qirui Pharmaceutical Technology Co., Ltd.

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100 Clinical Results associated with Alfatide[18F]

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100 Translational Medicine associated with Alfatide[18F]

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100 Patents (Medical) associated with Alfatide[18F]

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6

Literatures (Medical) associated with Alfatide[18F]

01 Jan 2015·TheranosticsQ1 · MEDICINE

Pilot Prospective Evaluation of ¹⁸F-Alfatide II for Detection of Skeletal Metastases

Q1 · MEDICINE

ArticleOA

Author: Yang, Min ; Mi, Baoming ; Wan, Weixing ; Pan, Donghui ; Niu, Gang ; Chen, Xiaoyuan ; Yu, Chunjing

This pilot prospective evaluation study is to verify the efficiency of (18)F-Alfatide II, a specific PET imaging agent for integrin αvβ3, in detecting bone metastasis in human, with comparison to (18)F-FDG PET. Thirty recruited patients underwent (18)F-FDG and (18)F-alfatide II PET/CT successively within days. The final diagnosis of bone lesions was established based on the comprehensive assessment of all available data and clinical follow-up, which fall into four groups: osteolytic, osteoblastic, mixed and bone marrow. Visual analysis and quantification of SUVmax were performed to compare the detection sensitivity of (18)F-Alfatide II and (18)F-FDG PET. Eleven patients were found to have a total of 126 bone metastasis lesions. (18)F-Alfatide II PET can detect the bone metastatic lesions with good contrast and higher sensitivity (positive rate of 92%) than (18)F-FDG PET (77%). Especially, (18)F-Alfatide II PET showed superiority to (18)F-FDG PET in detecting osteoblastic (70% vs. 53%) and bone marrow metastatic lesions (98% vs. 77%). In conclusion, (18)F-Alfatide II PET/CT can be used to detect skeletal and bone marrow metastases, with nearly 100% sensitivity in osteolytic, mixed and bone marrow lesions. The sensitivity of (18)F-Alfatide II PET/CT in osteoblastic metastases is relatively low but still significantly higher than that of (18)F-FDG PET/CT. This pilot clinical study warrants the further application of (18)F-Alfatide II PET/CT in metastatic lesion detection, patient management and drug therapy response monitoring.

01 Jan 2014·TheranosticsQ1 · MEDICINE

Longitudinal PET Imaging of Muscular Inflammation Using¹⁸F-DPA-714 and ¹⁸F-Alfatide II and Differentiation with Tumors

Q1 · MEDICINE

ArticleOA

Author: Kiesewetter, Dale O ; Li, Fang ; Lang, Lixin ; Zhu, Zhaohui ; Niu, Gang ; Yue, Xuyi ; Wu, Chenxi ; Chen, Xiaoyuan

AIM:

(18)F-DPA-714 is a PET tracer that recognizes macrophage translocator protein (TSPO), and (18)F-Alfatide II ((18)F-AlF-NOTA-E[PEG4-c(RGDfk)]2) is specific for integrin αvβ3. This study aims to apply these two tracers for longitudinal PET imaging of muscular inflammation, and evaluate the value of (18)F-DPA-714 in differentiating inflammation from tumor.

METHODS:

RAW264.7 mouse macrophage cells were used for cell uptake analysis of (18)F-DPA-714. A mouse hind limb muscular inflammation model was established by intramuscular injection of turpentine oil. For the inflammation model, PET imaging was performed at different days using (18)F-DPA-714 and (18)F-Alfatide II. The specificity of the imaging probes was tested by co- or pre-injection of PK11195 or unlabeled RGD (Arg-Gly-Asp) peptide. PET imaging using (18)F-DPA-714 was performed in A549, HT29, U87MG, INS-1, and 4T1 xenograft models. Immunofluorescence staining was performed to evaluate infiltrated macrophages and angiogenesis in inflammation and/or tumors.

RESULTS:

Uptake of (18)F-DPA-714 in RAW264.7 cells was 45.5% at 1 h after incubation, and could be blocked by PK11195. PET imaging showed increased (18)F-DPA-714 and (18)F-Alfatide II uptake at inflammatory muscles. Peak uptake of (18)F-DPA-714 was seen on day 6 (4.02 ± 0.64 %ID/g), and peak uptake of (18)F-Alfatide II was shown on day 12 (1.87 ± 0.35 %ID/g) at 1 h p.i.. Tracer uptakes could be inhibited by PK11195 for (18)F-DPA-714 or cold RGD for (18)F-Alfatide II. Moreover, macrophage depletion with liposomal clodronate also reduced the local accumulation of both tracers. A549, HT29, U87MG, INS-1, and 4T1 tumor uptakes of (18)F-DPA-714 (0.46 ± 0.28, 0.91 ± 0.08, 1.69 ± 0.67, 1.13 ± 0.33, 1.22 ± 0.55 %ID/g at 1 h p.i., respectively) were significantly lower than inflammation uptake (All P < 0.05).

CONCLUSION:

PET imaging using (18)F-DPA-714 as a TSPO targeting tracer could evaluate the dynamics of macrophage activation and infiltration in different stages of inflammatory diseases. The concomitant longitudinal PET imaging with both (18)F-DPA-714 and (18)F-Alfatide II matched the causal relationship between macrophage infiltration and angiogenesis. Moreover, we found (18)F-DPA-714 uptake in several types of tumors is significantly lower than that in inflammatory muscles, suggesting (18)F-DPA-714 PET has the potential for better differentiation of tumor and non-tumor inflammation.

100 Deals associated with Alfatide[18F]

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 3	CN	Jiangsu Shimeikang Pharmaceutical Co. Ltd.	10 Dec 2021
Non-Small Cell Lung Cancer	Phase 3	CN	Taizhou Qirui Pharmaceutical Technology Co., Ltd.	10 Dec 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2020	Not Applicable	Esophageal Carcinoma	-	18F-Alfatide PET/CT	okjjoshkjs(denkjfbvjb) = ynbjfgqgkm cxjvnyaala (zrlkdltpxx, 0.96)	-	15 May 2020
				18F-FDGatide (18F-FDG PET/CT)	okjjoshkjs(denkjfbvjb) = juajzoueht cxjvnyaala (zrlkdltpxx, 1.10)
SNMMI2018	Not Applicable	-	-	Apatinib	crubarnboe(pquugoctvs) = Metabolic uptakes of thyroid (SUVthyroid), liver (SUVliver), cardia (SUVcardia), stomach body (SUVstomach body), stomach pyloric portion (SUV stomach pyloric portion) and spleen (SUVspleen) were predictive for fatigue gjioiumqjt (isusaioriu ) View more	-	23 May 2018
SNMMI2017	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	-	18F-alfatide PET/CT	ntdisurbmc(ixxiimzyjy): OR = 0.384 (95% CI, 0.158 - 0.931) View more	-	24 May 2017
				18F-FDGfatide (18F-FDG PET/CT)
SNMMI2016	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	12	18F-Alfatide RGD PET (Responder group)	dqkgqyruhq(pierlacdtj) = hyltslxnxo wmfrrfxhaa (hytwugybwo, 5.89)	Positive	24 May 2016
				18F-Alfatide RGD PET (Non-responder group)	dqkgqyruhq(pierlacdtj) = kkvnpcwhak wmfrrfxhaa (hytwugybwo, 12.53)
ASCO2016	Not Applicable	Locally Advanced Lung Non-Small Cell Carcinoma	12	18F-alfatide RGD PET/CT (Responder group)	ysbpmqcimm(nwijccpmbs) = riqxkrmqnf rsdkxqzefq (pdtoukscht )	Positive	20 May 2016
				18F-alfatide RGD PET/CT (Non-responder group)	ysbpmqcimm(nwijccpmbs) = umnxpcgmgv rsdkxqzefq (pdtoukscht )
SNMMI2015	Not Applicable	-	-	18F-alfatide II (Male phantom)	zdlejgqdnv(wdtluxgmia) = ysgqgkrxlj ywhtrqiygg (kchsaaauyi ) View more	-	15 May 2015
				18F-alfatide II (Female phantom)	zdlejgqdnv(wdtluxgmia) = osxbrsvfss ywhtrqiygg (kchsaaauyi ) View more