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

13:30 EDT 22nd May 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 [14 Associated News Articles listed on BioPortfolio]

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WHIPPANY, N.J., May 17, 2017 /PRNewswire/ -- Bayer announced today that the latest research from across its growing oncology portfolio will be presented at the 53rd Annual Meeting of the American...

Human medicines European public assessment report (EPAR): Xofigo, radium Ra223 dichloride, Revision: 6, Authorised

Updated Results from Phase 1/2 Trial of Betalutin® in NHL Accepted for Presentation at the International Conference on Malignant Lymphoma in June

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Bayer to Showcase Data on Growing Oncology Pipeline at AACR 2017

WHIPPANY, N.J., March 22, 2017 /PRNewswire/ -- Bayer announced today that the latest research from its growing oncology portfolio will be presented at the American Association for Cancer Research (AAC...

Bayer to Showcase Oncology Data at ASCO GU 2017

WHIPPANY, N.J., Feb. 15, 2017 /PRNewswire/ -- Bayer announced today that its latest research findings on Xofigo® (radium Ra 223 dichloride) injection will be presented at the 2017 Genitourinary ...

Prostate Cancer - Newer Antiandrogens & Emerging Therapies Targeting a "Watchful Waiting" and Resistance Population

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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 [32 Associated Clinical Trials listed on BioPortfolio]

Study Evaluating the Addition of Pembrolizumab to Radium-223 in mCRPC

This research study is studying the safety and tolerability of an investigational combination of drugs, radium-223 plus pembrolizumab as a possible treatment for castration-resistant prost...

Radium Ra 223 Dichloride and Niraparib in Treating Patients With Hormone- Resistant Prostate Cancer Metastatic to the Bone

This phase Ib trial studies the side effects and best dose of niraparib when given together with radium Ra223 dichloride in treating patients with prostate cancer that keeps growing even w...

Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT Following Radium-223 Therapy

Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer foll...

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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PubMed Articles [53 Associated PubMed Articles listed on BioPortfolio]

223Ra-dichloride response in a patient with Paget disease and bone metastases secondary to castration-resistant prostate cancer.

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Thallium activated sodium iodide (NaI(Tl)) detector and multi channel analyzer has been utilized to measure gamma rays emitted by radio nuclides found in soil samples of south-west (SW) region of Punj...

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Objectives 1,3-butadiene is classified as carcinogenic to human by inhalation and the association with leukemia has been observed in several epidemiological studies. The aim of this study was to evalu...

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Exposure to environmental toxicants during vulnerable windows of brain development is suspected to raise the prevalence for neurological dysfunctions at later stages in life. Differentiation processes...

"Simulated gastric hydrolysis and developmental toxicity of dioctyltin bis(2-Ethylhexylthioglycolate) DOTE in rabbits and mice".

Based on previous studies, dioctyltin dichloride [DOTC] was a putative toxophore for dioctyltin thioesters. Our results, generated with the use of (119)Sn-NMR spectroscopy demonstrated that dioctyltin...

Second-Line Hormonal Therapy for Men With Chemotherapy-Naïve, Castration-Resistant Prostate Cancer: American Society of Clinical Oncology Provisional Clinical Opinion.

Purpose ASCO provisional clinical opinions (PCOs) offer direction to the ASCO membership after publication or presentation of potential practice-changing data. This PCO addresses second-line hormonal ...

Ground State and Excited State Tuning in Ferric Dipyrrin Complexes Promoted by Ancillary Ligand Exchange.

Three ferric dipyrromethene complexes featuring different ancillary ligands were synthesized by one electron oxidation of ferrous precursors. Four-coordinate iron complexes of the type ((Ar)L)FeX2 [(A...

Radioactivity in wastes generated from shale gas exploration and production - North-Eastern Poland.

In the present study, the K-40, U-238, Ra-226, Pb-210, Ra-228 and Th-228 activity concentrations were measured in 64 samples of wastes generated from shale gas exploration in North-Eastern Poland. The...

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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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