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Xofigo (radium-223 dichloride) - Biotech, Pharma and Life Science Channel

00:50 EST 18th January 2017 | BioPortfolio

New treatment for castration-resistant prostate cancer (CRPC) patients with bone metastases.

Xofigo shown in a pivotal phase III trial to significantly improve overall survival.

Xofigo® with the active ingredient radium 223 dichloride (radium 223) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. Radium 223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium 223 is less than 100 micrometers, which may limit the damage to the surrounding normal tissue.

The US Food and Drug Administration (FDA) has approved Xofigo® (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA, that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III ALSYMPCA trial.

The commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare will co-promote the product in the US.

Source: http://www.algeta.com/news/

Xofigo® is a registered trademark of Bayer.

News Articles [16 Associated News Articles listed on BioPortfolio]

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Companies [4 Associated Companies listed on BioPortfolio]

Nextera Communications

Nextera is a privately owned Norwegian biotech company. Our approach is to manipulate the disease at the initiation of the escalating immune cascade by identifying and subsequentl...

Ultimovacs AS

Ultimovacs AS ('Ultimovacs') was established by Inven2 in 2011. The company's goal is to develop technology from the Norwegian Radium Hospital for use in cancer treatment and to m...

Targovax

Targovax was started in October 2010 to develop TG01, a vaccine targeting pancreatic cancer. TG01 is based on research from The Radium Hospital and Norsk Hydro in the end of the 9...

Axiall Corporation

Axiall Corporation is a leading integrated chemicals and building products company. It is an international manufacturer of chlor-alkali and derivatives, chlorovinyls and aromatics...

Clinical Trials [29 Associated Clinical Trials listed on BioPortfolio]

Value of FLT PET/CT in Radium-223 Therapy of mCRPC Patients

The aim of the study is to investigate whether positron emission tomography (PET) using the tracer 18F-Fluorothymidine (FLT) can provide information on proliferative activity in bone marro...

A Phase II Clinical Trial of Radium-223 Activity in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) With Asymptomatic Progression While on Abiraterone Acetate or Enzalutamide Besides AR-V7 Mutational Status (EXCAAPE)

Radium-223 is indicated for the treatment of patients with mCRPC with symptomatic bone metastases and no known visceral metastatic disease. However, very few data have been reported in pat...

Assess Gamma H2AX Positivity in Circulating Prostate Cancer Cells Before and After Radium 223

This is a prospective biomarker study on prostate cancer patients receiving Radium 223 as standard of care. Participants will take part in this research study because they have chosen Rad...

uPAR PET/CT in Radium-223-dichloride Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / CT molecular imaging in patients with ...

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib ...

Prostate Cancer Intensive, Non-Cross Reactive Therapy (PRINT) for Castration Resistant Prostate Cancer (CRPC)

The purpose of this study is to determine the clinical benefits of using a rapidly cycling, non-cross reactive regimen of FDA-approved prostate cancer therapeutic agents in the management ...

Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL)

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Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer

A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with t...

Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide ...

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Clinical Correlates of Benefit From Radium-223 Therapy in Metastatic Castration Resistant Prostate Cancer.

We sought to identify potential clinical variables associated with outcomes after radium-223 therapy in routine practice.

Estimation of coastal residence time of submarine groundwater discharge using radium progenies.

A methodology based on γ-spectrometry measurements of untreated coastal water samples is proposed for the direct estimation of coastal residence time of submarine discharged groundwater. The method w...

A primary standard source of radon-222 based on the HPGe detector.

The present paper describes the prototype of a calibration standard system for radon concentrations to be used in establishing the traceability of radon concentration measurements in dwellings. Radon ...

Determination of low-level Radium isotope activities in fresh waters by gamma spectrometry.

A new portable sampling system was developed to extract Radium isotopes from large volumes (up to 300L) of fresh surface- and ground-waters of low Ra-activities (

Effect of radium-223 dichloride (Ra-223) on hospitalisation: An analysis from the phase 3 randomised Alpharadin in Symptomatic Prostate Cancer Patients (ALSYMPCA) trial.

Symptomatic skeletal events (SSEs) commonly occur in patients with bone metastases, often leading to hospitalisations and decreased quality-of-life. In the ALSYMPCA trial, radium-223 significantly imp...

Radium-223: Insight and Perspectives in Bone-metastatic Castration-resistant Prostate Cancer.

(223)Ra prolongs overall survival in symptomatic patients affected by multiple bone-metastatic castration-resistant prostatic cancer, without visceral or nodal involvement. However, many questions rem...

Assessment of the Effects of MPTP and Paraquat on Dopaminergic Neurons and Microglia in the Substantia Nigra Pars Compacta of C57BL/6 Mice.

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Lymphocyte function following radium-223 therapy in patients with metastasized, castration-resistant prostate cancer.

Therapy with the alpha-emitter radium-223 chloride ((223)Ra) is an innovative therapeutic option in patients with metastasized, castration-resistant prostate cancer. However, radiotherapy can lead to ...

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Medical and Biotech [MESH] Definitions

Radium. A radioactive element of the alkaline earth series of metals. It has the atomic symbol Ra, atomic number 88, and atomic weight 226. Radium is the product of the disintegration of uranium and is present in pitchblende and all ores containing uranium. It is used clinically as a source of beta and gamma-rays in radiotherapy, particularly BRACHYTHERAPY.

1,1'-Bis(phenylmethyl)4,4'-bipyridinium dichloride. Oxidation-reduction indicator.

Radon. A naturally radioactive element with atomic symbol Rn, atomic number 86, and atomic weight 222. It is a member of the noble gas family and released during the decay of radium and found in soil. There is a link between exposure to radon and lung cancer.

Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.

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