Delving into the Latest Updates on Osteodex with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Alendronate/dextran/guanidine, ODX

Target-

Mechanism

Iron Supplements, Osteoclasts inhibitors

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [1]

Active Indication

Refractory Multiple Myeloma

Inactive Indication

Bone metastasesCastration-Resistant Prostatic CancerMetastatic castration-resistant prostate cancer+ [1]

Originator Organization

Dextech Medical AB

Active Organization

Dextech Medical AB

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaCH5N3

InChIKeyZRALSGWEFCBTJO-UHFFFAOYSA-N

CAS Registry113-00-8

View All Structures (2)

The current phase I/IIa trial is a multi-center, prospective, open-label, ascending dose study to evaluate safety and biological efficacy of up to 3 dose levels of ODX. Each dose cohort will consist of 4 subjects. Each subject will receive up to 7 doses of ODX, given at 2-week intervals, until unacceptable toxicity or disease progression. A follow-up visit will be conducted 2 weeks after the last dose.
Primary objectives:
• To determine the safety and tolerability of ODX in subjects with relapsed/refractory multiple myeloma.
Secondary objectives:
* To evaluate the preliminary efficacy of ODX, as determined by the IMWG response criteria, in subjects with relapsed/refractory multiple myeloma.
* To evaluate the efficacy of ODX on serum biomarkers (M-protein, FLC, CTX, osteocalcin, and bone-specific S-ALP) in subjects with relapsed/refractory multiple myeloma.
Exploratory objective
• To evaluate time to progression by following M-protein and FLC levels as per clinical routine

Start Date05 Sep 2023

Sponsor / Collaborator

Dextech Medical AB

EUCTR2015-005666-37-EE

/ Not yet recruitingPhase 2

A randomized, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases

Start Date08 Aug 2016

Sponsor / Collaborator

Dextech Medical AB

NCT02825628

/ CompletedPhase 2

A Randomised, Double-blind, Dose Finding, Repeat Dose Phase II Multicentre Study of ODX for the Treatment of Patients With Castration Resistant Prostate Cancer (CRPC) and Skeletal Metastases

This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases.
The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).

Start Date01 May 2016

Sponsor / Collaborator

Dextech Medical AB

100 Clinical Results associated with Osteodex

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100 Translational Medicine associated with Osteodex

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100 Patents (Medical) associated with Osteodex

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85

Literatures (Medical) associated with Osteodex

15 Dec 2024·Cancer

Assessing sociodemographic and regional disparities in Oncotype DX Genomic Prostate Score uptake

Article

Author: Negoita, Serban ; Petkov, Valentina I. ; Schwartz, Stephen M. ; Mukand, Nita H. ; Doherty, Jennifer A. ; Bennett, John ; Wu, Xiao‐Cheng ; Chung, Benjamin I. ; Li, Christopher ; Gomez, Scarlett Lin ; Aboushwareb, Tamer ; Lichtensztajn, Daphne ; Chirikova, Ekaterina ; Leppert, John T. ; Morawski, Bozena M. ; Cheng, Iona ; Brooks, James D. ; Insaf, Tabassum ; Stroup, Antionette ; Zambon, Joao Paulo ; Gershman, Susan T.

AbstractBackgroundThe Oncotype DX Genomic Prostate Score (ODX‐GPS) is a gene expression assay that predicts disease aggressiveness. The objective of this study was to identify sociodemographic and regional factors associated with ODX‐GPS uptake.MethodsData from Surveillance Epidemiology and End Results registries on men with localized prostate cancer with a Gleason score of 3 + 3 or 3 + 4, PSA ≤20 ng/mL, and stage T1c to T2c disease from 2013 through 2017 were linked with ODX‐GPS data. Census‐tract level neighborhood socioeconomic status (nSES) quintiles were constructed using a composite socioeconomic score. Multivariable logistic regression was used to estimate the associations of ODX‐GPS uptake with age at diagnosis, race and ethnicity, nSES, geographic region, insurance type, and marital status, accounting for National Comprehensive Cancer Network risk group, year of diagnosis, and clustering by census tract.ResultsAmong 111,434 eligible men, 5.5% had ODX‐GPS test uptake. Of these, 78.3% were non‐Hispanic White, 9.6% were Black, 6.7% were Hispanic, and 3.6% were Asian American. Black men had the lowest odds of ODX‐GPS uptake (odds ratio, 0.70; 95% confidence interval [CI], 0.63–0.76). Those in the highest versus lowest quintile of nSES were 1.64 times more likely (95% CI, 1.38–2.94) to have ODX‐GPS uptake. The odds of ODX‐GPS uptake were statistically significantly higher among men residing in the Northeast, West, and Midwest compared to the South.ConclusionsDisparities in ODX‐GPS uptake by race, ethnicity, nSES, and geographical region were identified. Concerted efforts should be made to ensure that this clinical test is equitably available.

01 Jul 2024·Cancer Diagnosis & Prognosis

Attempt to Substitute the Oncotype DX Breast Recurrence Score® Test by Histopathological Factors and MUC1 Protein Expression

Article

Author: Semba, Ryoko ; Watanabe, Junichiro ; Kawate, Takahiko ; Ueki, Yuko ; Horimoto, Yoshiya ; Nozaki, Yuka ; Ishizuka, Yumiko ; Hayashi, Takuo ; Onagi, Hiroko ; Ishikawa, Takashi

Background/Aim: Oncotype DX Breast Recurrence Score® test (ODx) is a gene profiling assay predicting the benefit of adjuvant chemotherapy for early-stage hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Meanwhile, to avoid unnecessary financial burden on the patient, many studies have attempted to establish alternatives to ODx using conventional clinicopathological factors, but these have not yet been successful. Thus, we retrospectively investigated clinicopathological factors to establish alternatives to ODx. Patients and Methods: Data from 114 Japanese women who underwent ODx were retrospectively examined to investigate the relationship between ODx recurrence score (RS) and clinicopathological features, including MUC1 staining patterns on immunohistochemical assessment. An RS of 0-25 was defined as low, and 26-100 as high. Results: Ninety patients (79%) had low RS and 24 patients (21%) had high RS. Univariate analysis revealed that low tumor grade, high progesterone receptor (PgR) expression, and low Ki67 labeling index (LI) were significantly associated with low RS (p=0.025, p<0.001, and p<0.001, respectively). Tumors with an apical pattern of MUC1 staining also frequently had a low RS (p=0.024). In multivariate analysis, PgR expression and Ki67 LI were independent factors associated with RS (p<0.001, for both). When the ODx results were categorized with a combination of these two factors, only 2% of the PgR-high and Ki67-low group (one in 51 cases) had a high RS. Conclusion: PgR expression and Ki67 LI were independent factors correlated with RS. MUC1 staining pattern also has the potential to be a useful marker. We believe that it is crucial to continue attempts to identify patients who are unlikely to benefit from ODx.

01 Jun 2024·The Breast

Is Oncotype DX testing informative for breast cancers with low ER expression? A retrospective review from a biomarker testing referral center

Article

Author: Carter, Michael D ; Loggie, John ; Bethune, Gillian C ; Barnes, Penelope J ; Rayson, Daniel

PURPOSEIt remains unclear whether patients with HER2-negative, low-estrogen receptor (ER-low)-positive early breast cancer (BC) benefit from Oncotype DX® (ODX) testing.METHODSWe conducted a retrospective review of cases referred for ODX testing over a seven-year period from a breast biomarker testing referral center (n = 854). For each case, we recorded the ODX Recurrence Score (RS) along with percentage of ER nuclear positivity and staining intensity on immunohistochemistry. Our criteria for ER-low was defined as ≤10% cells with nuclear positivity and/or weak intensity of staining. Slides from all ER-low cases were reviewed and the reported ODX ER gene scores were recorded. We randomly selected a comparator group of 56 patients with ER > 10% positivity and non-weak staining intensity (ER-high).RESULTSWe identified 27 cases (3.2%) that met our criteria for ER-low. Of these, 92.6% had a high RS (>25), and 7.4% had a RS of 25. All cases with ≤10% ER nuclear positivity had a high RS. Most ER-low cases (85.2%) had ODX quantitative ER gene scores in the negative range, whereas all (100%) ER-high cases had positive ER gene scores.CONCLUSIONODX does not appear to add significant additional information to inform treatment decisions for most patients with ER-low BC. Incorporating weak ER staining intensity in addition to low percentage of nuclear positivity identifies about twice as many ER-low patients, although with reduced specificity for high RS. Our study supports the contention that most ER-low early BC should be regarded similarly to ER-negative BC.

100 Deals associated with Osteodex

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bone metastases	Phase 3	SE	Dextech Medical AB	01 May 2016
Bone metastases	Phase 3	FI	Dextech Medical AB	01 May 2016
Bone metastases	Phase 3	EE	Dextech Medical AB	01 May 2016
Bone metastases	Phase 3	LV	Dextech Medical AB	01 May 2016
Castration-Resistant Prostatic Cancer	Phase 3	EE	Dextech Medical AB	01 May 2016
Castration-Resistant Prostatic Cancer	Phase 3	FI	Dextech Medical AB	01 May 2016
Castration-Resistant Prostatic Cancer	Phase 3	LV	Dextech Medical AB	01 May 2016
Metastatic Prostate Carcinoma	Phase 3	SE	Dextech Medical AB	01 Jan 2015
Metastatic castration-resistant prostate cancer	Preclinical	SE	Dextech Medical AB	01 Jan 2015
Metastatic Prostate Carcinoma	Preclinical	SE	Dextech Medical AB	01 Jan 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02825628 (Pubmed)	Phase 2	Castration-Resistant Prostatic Cancer bone alkaline phosphatase (B-ALP) \| serum-aminoterminal-propeptide of Type I procollagen (S-P1NP) \| serum C-terminal telopeptide	55	ODX 3 mg/kg	erexrrdzlo(wcdtbwjola) = urxiypgpmb yjmyvkhttt (muvksxqrnp )	-	01 Mar 2023
				ODX 6 mg/kg	erexrrdzlo(wcdtbwjola) = jrkkjfsbjh yjmyvkhttt (muvksxqrnp )