Osteodex(Osteodex) - 在研适应症：多发性骨髓瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Alendronate/dextran/guanidine、ODX

靶点-

作用机制

铁补充剂、破骨细胞抑制剂

治疗领域

肿瘤免疫系统疾病心血管疾病+ [1]

在研适应症

多发性骨髓瘤

非在研适应症

骨转移癌去势抵抗性前列腺癌转移性去势抵抗性前列腺癌+ [1]

原研机构

Dextech Medical AB

在研机构

Dextech Medical AB

非在研机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式CH5N3

InChIKeyZRALSGWEFCBTJO-UHFFFAOYSA-N

CAS号113-00-8

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关联

6

项与 Osteodex 相关的临床试验

NCT06616389 / Recruiting临床1/2期

A Phase I/IIa Study of ODX (OsteoDex) in Multiple Myeloma

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

开始日期2023-09-05

申办/合作机构

Dextech Medical AB

EUCTR2015-005666-37-LV / Not yet recruiting临床2期

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

开始日期2016-08-15

申办/合作机构

Dextech Medical AB

NCT02825628 / Completed临床2期

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).

开始日期2016-05-01

申办/合作机构

Dextech Medical AB

100 项与 Osteodex 相关的临床结果

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100 项与 Osteodex 相关的转化医学

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100 项与 Osteodex 相关的专利（医药）

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82

项与 Osteodex 相关的文献（医药）

2024-07-01·Cancer Diagnosis & Prognosis

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

Article

作者: 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.

2024-06-01·The Breast

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

Article

作者: 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.

2024-05-01·Cancer Epidemiology, Biomarkers & Prevention

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

Article

作者: 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 项与 Osteodex 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨转移癌	临床3期	芬兰	Dextech Medical AB	2016-05-01
骨转移癌	临床3期	拉脱维亚	Dextech Medical AB	2016-05-01
骨转移癌	临床3期	爱沙尼亚	Dextech Medical AB	2016-05-01
骨转移癌	临床3期	瑞典	Dextech Medical AB	2016-05-01
去势抵抗性前列腺癌	临床3期	瑞典	Dextech Medical AB	2016-05-01
去势抵抗性前列腺癌	临床3期	芬兰	Dextech Medical AB	2016-05-01
去势抵抗性前列腺癌	临床3期	拉脱维亚	Dextech Medical AB	2016-05-01
转移性前列腺癌	临床3期	瑞典	Dextech Medical AB	2015-01-01
转移性去势抵抗性前列腺癌	临床前	瑞典	Dextech Medical AB	2015-01-01
转移性前列腺癌	临床前	瑞典	Dextech Medical AB	2015-01-01