Delving into the Latest Updates on DW-166HC with Synapse

Overview

Basic Info

Drug Type

Small molecule drug, Therapeutic radiopharmaceuticals

Synonyms

166 holmium chitosan complex, 166 holmium poliglusam, Holmium 166 chitosan

+ [2]

Target-

Mechanism

Ionising radiation emitters

Therapeutic Areas

NeoplasmsCongenital DisordersDigestive System Disorders+ [3]

Active Indication

Liver CancerHemophilia AHepatocellular Carcinoma+ [1]

Inactive Indication

Brain CancerRheumatoid Arthritis

Originator Organization

DONG WHA PHARM Co., Ltd.

Active Organization

DONG WHA PHARM Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

KR (01 Jan 2001),

Hemophilia AHepatocellular CarcinomaSkin Neoplasms

Regulation-

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Holmium-166 microspheres are used for the transarterial radioembolization (TARE) treatment of primary and secondary liver cancers. In this study, its efficacy regarding local tumor control and integration into the oncological treatment sequence of the first 20 patients treated in our institution were examined. A total of twenty-nine ¹⁶⁶Ho-TARE procedures were performed to treat hepatocellular carcinoma (HCC, fourteen patients), metastatic colorectal cancer (mCRC, four patients), intrahepatic cholangiocarcinoma (ICC, one patient), and hemangioendothelioma of the liver (HE, one patient). In eight patients, ¹⁶⁶Ho-TARE was the initial oncologic treatment. In patients with HCC, the median treated-liver progression-free survival (PFS), overall PFS, and overall survival after ¹⁶⁶Ho-TARE were 10.3, 7.3, and 22.1 months; in patients with mCRC, these were 2.6, 2.9, and 20.6 months, respectively. Survival after ¹⁶⁶Ho-TARE in the patients with ICC and HE were 5.2 and 0.8 months, respectively. Two patients with HCC were bridged to liver transplantation, and one patient with mCRC was downstaged to curative surgery. In patients with HCC, a median treatment-free interval of 7.3 months was achieved. In line with previous publications, ¹⁶⁶Ho-TARE was a feasible treatment option in patients with liver tumors, with favorable clinical outcomes in the majority of cases. It was able to achieve treatment-free intervals, served as bridging-to-transplant, and did not prevent subsequent therapies.

01 Feb 2023·Medical physics

Improving MRI‐based dosimetry for holmium‐166 transarterial radioembolization using a nonrigid image registration for voxelwise ΔR2∗$\Delta R_2^*$ calculation

Article

Author: Roosen, Joey ; Lobeek, Daphne ; Nijsen, J. Frank W. ; Arntz, Mark J. ; van Wijk, Meike W. M. ; Overduin, Christiaan G. ; Janssen, Marcel J. R. ; Westlund Gotby, Lovisa E. L. ; van de Maat, Gerrit H.

Abstract:

Background:

Transarterial radioembolization (TARE) is a treatment modality for liver tumors during which radioactive microspheres are injected into the hepatic arterial system. These microspheres distribute throughout the liver as a result of the blood flow until they are trapped in the arterioles because of their size. Holmium‐166 (166Ho)‐loaded microspheres used for TARE can be visualized and quantified with MRI, as holmium is a paramagnetic metal and locally increases the transverse relaxation rate . The current 166Ho quantification method does not take regional differences in baseline values (such as between tumors and healthy tissue) into account, which intrinsically results in a systematic error in the estimated absorbed dose distribution. As this estimated absorbed dose distribution can be used to predict response to treatment of tumors and potential toxicity in healthy tissue, a high accuracy of absorbed dose estimation is required.

Purpose:

To evaluate pre‐existing differences in distributions between tumor tissue and healthy tissue and assess the feasibility and accuracy of voxelwise subtraction‐based calculation for MRI‐based dosimetry of holmium‐166 transarterial radioembolization (166Ho TARE).

Methods:

MRI data obtained in six patients who underwent 166Ho TARE of the liver as part of a clinical study was retrospectively evaluated. Pretreatment differences in distributions between tumor tissue and healthy tissue were characterized. Same‐day pre‐ and post‐treatment maps were aligned using a deformable registration algorithm and subsequently subtracted to generate voxelwise maps and resultant absorbed dose maps. Image registration accuracy was quantified using the dice similarity coefficient (DSC), relative overlay (RO), and surface dice (≤4 mm; SDSC). Voxelwise subtraction‐based absorbed dose maps were quantitatively (root‐mean‐square error, RMSE) and visually compared to the current MRI‐based mean subtraction method and routinely used SPECT‐based dosimetry.

Results:

Pretreatment values were lower in tumors than in healthy liver tissue (mean 36.8 s−1 vs. 55.7 s−1, P = 0.004). Image registration improved the mean DSC of 0.83 (range: 0.70–0.88) to 0.95 (range: 0.92–0.97), mean RO of 0.71 (range 0.53–0.78) to 0.90 (range: 0.86–0.94), and mean SDSC ≤4 mm of 0.47 (range: 0.28–0.67) to 0.97 (range: 0.96–0.98). Voxelwise subtraction‐based absorbed dose maps yielded a higher tumor‐absorbed dose (median increase of 9.0%) and lower healthy liver‐absorbed dose (median decrease of 13.8%) compared to the mean subtraction method. Voxelwise subtraction‐based absorbed dose maps corresponded better to SPECT‐based absorbed dose maps, reflected by a lower RMSE in three of six patients.

Conclusions:

Voxelwise subtraction presents a robust alternative method for MRI‐based dosimetry of 166Ho microspheres that accounts for pre‐existing differences, and appears to correspond better with SPECT‐based dosimetry compared to the currently implemented mean subtraction method.

01 Jul 2020·Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicineQ3 · ENGINEERING & TECHNOLOGY

A kit based methodology for convenient formulation of 166Ho-Chitosan complex for treatment of liver cancer

Q3 · ENGINEERING & TECHNOLOGY

Article

Author: Chakraborty, Sudipta ; Dash, Ashutosh ; Chakravarty, Rubel ; Sarma, Haladhar Dev ; Lohar, Sharad ; Jadhav, Sachin

The effectiveness of ¹⁶⁶Ho-chitosan complex as a radiopharmaceutical for trans-arterial radiation therapy of liver cancer has been established in clinical trials. We have developed a simple kit-bade strategy for convenient formulation of therapeutically relevant doses of ¹⁶⁶Ho-chitosan complex in a hospital radiopharmacy in order to facilitate its widespread utilization. Quality control studies established the suitability of the radiopharmaceutical formulated using the developed strategy for in vivo administration. Biodistribution studies in normal Wistar rats showed excellent retention of the radiopharmaceutical in the liver, thus, paving the way towards utility of this approach in clinical context.

100 Deals associated with DW-166HC

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Liver Cancer	KR	DONG WHA PHARM Co., Ltd.	01 Nov 2007
Hemophilia A	KR	DONG WHA PHARM Co., Ltd.	01 Jan 2001
Hepatocellular Carcinoma	KR	DONG WHA PHARM Co., Ltd.	01 Jan 2001
Skin Neoplasms	KR	DONG WHA PHARM Co., Ltd.	01 Jan 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	KR	DONG WHA PHARM Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2004	Not Applicable	Hepatocellular Carcinoma	54	Holmium-166-Chitosan complex	idzzsenhla(qtzfsferqj) = cfactvcjkr azgcfappgj (sgqielvtna )	Positive	15 Jul 2004