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

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-

Login to view timeline

Structure

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-LV / 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 Date15 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

Login to view more data

100 Translational Medicine associated with Osteodex

Login to view more data

100 Patents (Medical) associated with Osteodex

Login to view more data

82

Literatures (Medical) associated with Osteodex

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 ; Nozaki, Yuka ; Ueki, Yuko ; Ishizuka, Yumiko ; Horimoto, Yoshiya ; 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.

01 May 2024·Cancer Epidemiology, Biomarkers & Prevention

Addressing Social Determinants in the Era of Precision Medicine in Breast Cancer: Is It Sufficient to Reduce Disparities?

Article

Author: Huo, Dezheng ; Freeman, Jincong Q

AbstractThe Oncotype DX (ODX) assay predicts recurrence risk and demonstrates the benefits of adjuvant therapy in patients with early-stage, hormone receptor (HR)-positive/HER2-negative breast cancer. ODX uptake varies by patients’ racial/ethnic backgrounds and socioeconomic status (SES). However, community-level variability remains unknown, and research regarding the association between testing status and receipt of adjuvant chemotherapy is limited. To fill these knowledge gaps, Van Alsten and colleagues found a 6% lower prevalence of ODX uptake among patients residing in high SES-deprived areas than among those residing in low SES-deprived areas. Among patients with low and median ODX recurrence scores, those who underwent testing were 28% and 21% less likely to receive adjuvant chemotherapy than those who did not, respectively. The findings emphasize the role of social determinants of health. However, to further reduce or eliminate racial/ethnic disparities and SES inequities, we would need sufficient and effective multi-level approaches. These involve lower ODX testing costs, health insurance coverage expansion, re-classification and validation of ODX recurrence scores in patients of minority ancestry, and the development of a faster, more accurate, and affordable test.See related article by Van Alsten et al., p. 654

100 Deals associated with Osteodex

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bone metastases	Phase 3	FI	Dextech Medical AB	01 May 2016
Bone metastases	Phase 3	LV	Dextech Medical AB	01 May 2016
Bone metastases	Phase 3	EE	Dextech Medical AB	01 May 2016
Bone metastases	Phase 3	SE	Dextech Medical AB	01 May 2016
Castration-Resistant Prostatic Cancer	Phase 3	SE	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