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386888

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Amyloidosis
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government which of the four phase 2 or 3 clinical trials for systemic amyloidosis approved since 2004 are still ongoing; and whether any of the trials have produced sufficient positive outcomes to encourage commercial development.
	tabling member printed	Lord Willis of Knaresborough
	uin	HL997
	answer	answer is ministerial correction date of answer 14/07/2015 answer text <p>There are four trials for systemic amyloidosis that are designated as ‘ongoing’ in the United Kingdom. These are being conducted by two commercial sponsors, Millennium Pharmaceuticals Inc and A.T. Development Switzerland Sarl (two studies), and one non-commercial sponsor, European Myeloma Network.</p><p> </p><p> </p><p> </p><p>Clinical trial sponsors are required to publish a summary of their trial results to the EU Clinical Trials Register within one year of their trial completing. At that point, these results will become publically available on the EU Clinical Trials Register</p><p> </p><p> </p><p> </p><p>The Department of Health, which funds the National Institute for Health Research (NIHR), is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report that includes an assessment of progress in these areas is attached and available on the NCRI website at:</p><p> </p><p><a href="http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf" target="_blank">http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf</a>.</p><p> </p><p> </p><p> </p><p>We cannot comment on commercial considerations. When the results are known, the commercial potential of these trial’s products will be a matter for the respective trial sponsors.</p><p> </p> answering member printed Lord Prior of Brampton grouped question UIN HL995 HL996 question first answered 14/07/2015 15:34:29 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf title 2013-14 Annual Report
	tabling member	4151 label Biography information for Lord Willis of Knaresborough

386887

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Amyloidosis
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government whether there are currently any trials for systemic amyloidosis in humans being conducted by the National Institute of Health Research charities or the commercial sector.
	tabling member printed	Lord Willis of Knaresborough
	uin	HL996
	answer	answer is ministerial correction date of answer 14/07/2015 answer text <p>There are four trials for systemic amyloidosis that are designated as ‘ongoing’ in the United Kingdom. These are being conducted by two commercial sponsors, Millennium Pharmaceuticals Inc and A.T. Development Switzerland Sarl (two studies), and one non-commercial sponsor, European Myeloma Network.</p><p> </p><p> </p><p> </p><p>Clinical trial sponsors are required to publish a summary of their trial results to the EU Clinical Trials Register within one year of their trial completing. At that point, these results will become publically available on the EU Clinical Trials Register</p><p> </p><p> </p><p> </p><p>The Department of Health, which funds the National Institute for Health Research (NIHR), is a member of the National Cancer Research Institute (NCRI). NCRI Clinical Studies Groups (CSGs) bring together clinicians, scientists, statisticians and lay representatives to coordinate development of a strategic portfolio of trials within their field. All CSGs interact with clinical research networks, funders (including NIHR) and researchers to develop studies aimed at improving outcomes for patients. The Haematological Oncology CSG has a Myeloma Subgroup and its 2013-14 annual report that includes an assessment of progress in these areas is attached and available on the NCRI website at:</p><p> </p><p><a href="http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf" target="_blank">http://csg.ncri.org.uk/wp-content/uploads/2014/11/NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf</a>.</p><p> </p><p> </p><p> </p><p>We cannot comment on commercial considerations. When the results are known, the commercial potential of these trial’s products will be a matter for the respective trial sponsors.</p><p> </p> answering member printed Lord Prior of Brampton grouped question UIN HL995 HL997 question first answered 14/07/2015 15:34:29 answering member 127 label Biography information for Lord Prior of Brampton attachment 1 file name NCRI-Haem-Onc-CSG-Annual-Report-2013-14.pdf title 2013-14 Annual Report
	tabling member	4151 label Biography information for Lord Willis of Knaresborough

386884

	registered interest
	date	01/07/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Amyloidosis
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government what progress has been made on setting up a study to image amyloid deposition in systemic amyloidosis using hybrid positron emission tomography-magnetic resonance imaging; where the study is located; how many patients have been recruited; when the study is expected to complete its initial work; and where the results will be published.
	tabling member printed	Lord Willis of Knaresborough
	uin	HL993
	answer	answer is ministerial correction date of answer 14/07/2015 answer text <p>This is a single centre study at University College London Hospital. It has now been set up and one patient has been recruited and scanned. The current planned date for end of recruitment is 1 October 2016. It is anticipated that the data will be analysed and submitted for publication in a peer reviewed journal within a year of the end of recruitment.</p><p> </p> answering member printed Lord Prior of Brampton question first answered 14/07/2015 15:36:20 answering member 127 label Biography information for Lord Prior of Brampton
	tabling member	4151 label Biography information for Lord Willis of Knaresborough

421282

	registered interest
	date	14/10/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Amyloidosis
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government, following the successful Phase 1 trials combining CPHPC and the antibody –SAP for the treatment of Amyloidosis, when they expect Phase 2 trials to commence, and what resource the National Institute for Health Research is making available to University College London to support this work.
	tabling member printed	Lord Willis of Knaresborough
	uin	HL2653
	answer	answer is ministerial correction date of answer 22/10/2015 answer text <p>Results in the first 15 patients with systemic amyloidosis treated with a combination of CPHPC and anti-SAP antibody have been published in the <em>New England Journal of Medicine</em>. The phase I study is funded by GlaxoSmithKline (GSK) and the research team includes researchers at University College London (UCL) and the National Amyloidosis Centre (NAC).</p><br /><p>The National Institute for Health Research Clinical Research Network (CRN) provides support to help the life sciences industry delivery high quality commercial contract clinical research in the national health service. If a phase II trial is developed, the CRN will work with GSK, the NAC and UCL as appropriate, to deliver the trial.</p> answering member printed Lord Prior of Brampton grouped question UIN HL2652 question first answered 22/10/2015 12:13:17 answering member 127 label Biography information for Lord Prior of Brampton
	tabling member	4151 label Biography information for Lord Willis of Knaresborough

421281

	registered interest
	date	14/10/2015
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Amyloidosis
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty’s Government what progress is being made by University College London in association with the National Amyloidosis Centre and GlaxoSmithKline to develop a combined small molecule antibody treatment for amyloidosis.
	tabling member printed	Lord Willis of Knaresborough
	uin	HL2652
	answer	answer is ministerial correction date of answer 22/10/2015 answer text <p>Results in the first 15 patients with systemic amyloidosis treated with a combination of CPHPC and anti-SAP antibody have been published in the <em>New England Journal of Medicine</em>. The phase I study is funded by GlaxoSmithKline (GSK) and the research team includes researchers at University College London (UCL) and the National Amyloidosis Centre (NAC).</p><br /><p>The National Institute for Health Research Clinical Research Network (CRN) provides support to help the life sciences industry delivery high quality commercial contract clinical research in the national health service. If a phase II trial is developed, the CRN will work with GSK, the NAC and UCL as appropriate, to deliver the trial.</p> answering member printed Lord Prior of Brampton grouped question UIN HL2653 question first answered 22/10/2015 12:13:17 answering member 127 label Biography information for Lord Prior of Brampton
	tabling member	4151 label Biography information for Lord Willis of Knaresborough

722130

	registered interest
	date	18/04/2017
	answering body	Department of Health
	answering dept id	17
	answering dept short name	Health
	answering dept sort name	Health
	hansard heading	Amyloidosis
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health, how many people have been diagnosed with amyloidosis in each of the last five years.
	tabling member constituency	Strangford
	tabling member printed	Jim Shannon
	uin	71136
	answer	answer is ministerial correction date of answer 26/04/2017 answer text <p>The Department does not hold data on the number of patients diagnosed with amyloidosis.</p><p> </p><p>The National Amyloidosis Centre at University College Hospital, London estimates that there are around 600 new cases of the condition each year.</p> answering member constituency Oxford West and Abingdon answering member printed Nicola Blackwood question first answered 26/04/2017 09:25:38 answering member 4019 label Biography information for Baroness Blackwood of North Oxford
	tabling member	4131 label Biography information for Jim Shannon