Delving into the Latest Updates on 188Re-HEDP with Synapse

Overview

Basic Info

Drug Type

Small molecule-drug conjugates, Therapeutic radiopharmaceuticals

Synonyms

Etidronate-Re-188, Etidronate-Rhenium-188, Re-188-etidronate

+ [4]

Target-

Mechanism

Osteoblasts inhibitors

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication-

Inactive Indication

Advanced Prostate CarcinomaBone metastasesCastration-Resistant Prostatic Cancer+ [1]

Originator Organization

Shanghai Atom Kexing Pharmaceutical Colltd

Active Organization-

Inactive Organization

Stichting Onderzoek Cancer Center Amsterdam

Jiangsu Rhentai Pharmaceutical Biotechnology Co., Ltd.

Shanghai Institute of Applied Physics, Chinese Academy of Sci

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Structure

Molecular FormulaC2H8O7P2Re

InChIKeyIRNIPRCGJQWCNJ-NLQOEHMXSA-N

CAS Registry145571-93-3

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Radium-223 chloride is an alpha-emitting radiopharmaceutical with proven survival benefit in patients with castration-resistant prostate cancer metastatic to bone. Beta-emitting radiopharmaceuticals have proven efficacy for palliating malignant bone pain. Nowadays, rhenium-188-HEDP is used in clinical practice for pain relief and palliative care. Several studies suggest that also rhenium-188-HEDP has the potential to improve overall survival. The purpose of this study is to investigate if treatment with rhenium-188-HEDP results in improvement of overall survival compared to treatment with radium-223-chloride.

Start Date16 May 2018

Sponsor / Collaborator

Stichting Onderzoek Cancer Center Amsterdam

100 Clinical Results associated with 188Re-HEDP

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100 Translational Medicine associated with 188Re-HEDP

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100 Patents (Medical) associated with 188Re-HEDP

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40

Literatures (Medical) associated with 188Re-HEDP

01 Jul 2021·International Journal of Clinical OncologyQ3 · MEDICINE

Efficacy and safety of 188Re-HEDP in lung cancer patients with bone metastases: a randomized, multicenter, multiple-dose phase IIa study

Q3 · MEDICINE

Article

Author: Chen, Ping ; Zuo, Changjing ; Gui, Jicong ; Li, Jun ; Liu, Xingdang ; Lv, Zhongwei ; Liu, Zengli ; ZhangLi, Yingjian Biao ; Liu, Congjin ; Wang, Yuankai ; Kuai, Dayu ; Wu, Yiwei ; Zhang, Guangming

PURPOSETo investigate the pain-relieving effect and safety of three different doses of ¹⁸⁸Re-hydroxyethylidine diphosphonate (HEDP) in patients with lung cancer and bone metastases.METHODSFor this randomised, phase 2 and multicenter trial, we enrolled patients with lung carcinoma and multifocal bone metastases and excluded patients who had received bisphosphonates or external-beam radiotherapy within the previous 4 weeks. Fifty-four patients were randomized to receive a single injection of ¹⁸⁸Re-HEDP, at doses of 30, 40 or 50 MBq/kg (interval, 12 weeks). Patients were followed-up by assessment of numerical rating scale (NRS) score, global quality of life (QOL) score and adverse events (AEs). ANOVA analysis, Chi-Squared test and LSD-t test were used in this study.RESULTSSignificantly decreased NRS scores relative to baseline were observed in 40 MBq/kg group (Week 0 vs. Week 12: 6.0 ± 1.4 vs. 4.8 ± 2.5, P = 0.033) and 50 MBq/kg group (Week 0 vs. Week 12: 5.5 ± 1.5 vs. 4.5 ± 2.9, P = 0.046). Significant change of global QOL score from baseline was observed in 40 MBq/kg group at week 8 (global QOL score: P = 0.024, pain score: P = 0.041) and 50 MBq/kg group (pain score: P = 0.021) at week 12. No patients withdrew trial because of AEs in three groups.CONCLUSIONS¹⁸⁸Re-HEDP at dose of 40 and 50 MBq/kg was generally effective to alleviate pain and improve QOL in lung cancer patients with painful bone metastases. ¹⁸⁸Re-HEDP was safe and well-tolerated.

01 Oct 2018·World Journal of Nuclear Medicine

Clinical utility of 188Rhenium-hydroxyethylidene-1,1-diphosphonate as a bone pain palliative in multiple malignancies

Article

Author: Sairam, Madhu ; Shinto, Ajit ; Joseph, Jephy ; Mallia, Madhava ; Kamaleshwaran, K ; Upadhyay, Indira ; Kameswaran, Mythili ; Subramaniam, R ; Dash, Ashutosh ; Banerjee, Sharmila ; Radhakrishnan, E

188Rhenium-hydroxyethylidene-1,1-diphosphonate (188Re-HEDP) is a clinically established radiopharmaceutical for bone pain palliation of patients with metastatic bone cancer. Herein, the effectiveness of 188Re-HEDP for the palliation of painful bone metastases was investigated in an uncontrolled initial trial in 48 patients with different types of advanced cancers. A group of 48 patients with painful bone metastases of lung, prostate, breast, renal, and bladder cancer was treated with 2.96–4.44 GBq of 188Re-HEDP. The overall response rate in this group of patients was 89.5%, and their mean visual analog scale score showed a reduction from 9.1 to 5.3 (P < 0.003) after 1 week posttherapy. The patients did not report serious adverse effects either during intravenous administration or within 24 h postadministration of 188Re-HEDP. Flare reaction was observed in 54.2% of patients between day 1 and day 3. There was no correlation between flare reaction and response to therapy (P < 0.05). Although bone marrow suppression was observed in patients receiving higher doses of 188Re-HEDP, it did not result in any significant clinical problems. The present study confirmed the clinical utility and cost-effectiveness of 188Re-HEDP for palliation of painful bone metastases from various types of cancer in developing countries.

01 Jul 2018·World Journal of Nuclear Medicine

188Re-HEDP therapy in the therapy of painful bone metastases

Review

Author: Liepe, Knut

For bone-targeted radionuclide therapy (BTRT), different commercial radiopharmaceuticals are available such as strontium-89, 186Rhenium-hydroxyethylidene diphosphonate (186Re-HEDP), Samarium-153-ethylenediamine tetramethylene phosphonic acid, and radium-223. Unfortunately, the commercial available radiopharmaceuticals are very expensive (from 1,200 to 36,000€ per patient in Europe). The 188W/188Re generator is an ideal source for the long-term (4–6 months) continuous availability of 188Re suitable for the preparation of radiopharmaceuticals for different radionuclide therapies. Labeling at HEDP, it can use cost-effective for BTRT, if enough patients are available for therapy. And so, 188Re-HEDP is the ideal candidate in developing countries which high population to replace the other agents. Two German groups documented a response rate of 80% without any severe side effects and similar bone marrow toxicity compared to the other compounds for 188Re-HEDP. Using 188Re-HEDP in repeated treatments, a prolonged overall survival of repeated to single application was observed (from 4.5 months for single to 15.7 months using ≥≥3 applications).

100 Deals associated with 188Re-HEDP

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	Phase 3	CN	Shanghai Institute of Applied Physics, Chinese Academy of Sci	15 Jun 2020
Castration-Resistant Prostatic Cancer	Phase 3	CN	Jiangsu Rhentai Pharmaceutical Biotechnology Co., Ltd.	15 Jun 2020
Advanced Prostate Carcinoma	Phase 3	NL	Stichting Onderzoek Cancer Center Amsterdam	16 May 2018
Metastatic castration-resistant prostate cancer	Phase 3	NL	Stichting Onderzoek Cancer Center Amsterdam	16 May 2018
Bone metastases	Phase 3	CN	Jiangsu Rhentai Pharmaceutical Biotechnology Co., Ltd.	12 Sep 2013
Bone metastases	Phase 3	CN	Shanghai Institute of Applied Physics, Chinese Academy of Sci	12 Sep 2013

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NTR3233 (ASCO2016)	Phase 1	Metastatic castration-resistant prostate cancer Second line	12	Cabazitaxel + rhenium-188-HEDP	ajdyispacj(jrdazyhbao) = after the 2nd cycle of re-188 (thrombopenia grade 3 causing delay of the next cycle of treatment) blkwghjacd (juqrnzmfcr )	-	20 May 2016
SNMMI2014	Not Applicable	Bone metastases	21	Re-188 HEDP	ipmoozsgpw(pawlmbyfiv) = Relevant but reversible hematotoxicity (grade 3/4) occurred in 6 patients (28.5%) and 8 administrations (11.9%) with leukopenia and thrombocytopenia in 3% and anemia in 7.5% uozndmyjhq (oqbuzykaii )	Positive	05 Nov 2014
ASCO2004	Not Applicable	Bone metastases	61	Rhenium-188 HEDP	(tzrjotgmth) = riuerfbjtw syjafpwuew (zdjoupexhd )	Positive	15 Jul 2004