~ ATIR201™ on track to enter Phase I/II clinical development in Q1 2016 ~
Amsterdam, The Netherlands, December 21, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces a collaboration with the Thalassaemia International Federation (TIF), an internationally renowned organisation that seeks to address the needs of patients, carers, healthcare professionals and the general public in the area of thalassaemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient.
With support of international thalassaemia experts, through the extensive network of the TIF, Kiadis Pharma aims to develop innovative products to improve treatment of thalassaemia patients and will be entering clinical development in the first quarter of 2016. Kiadis Pharma believes that its product ATIR201™ has the potential to address the current risks and limitations connected with hematopoietic stem cell transplantation (HSCT), being graft-versus-host disease (GVHD), opportunistic infections and limited donor availability, and make HSCT a first-choice treatment of β-thalassaemia major.
The collaboration will allow the TIF to further expand its international educational and awareness programs for patients and health-care professionals, with a specific focus on hematopoietic stem cell transplantation (HSCT) as a curative treatment for thalassaemia patients.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “Given our commitment to thalassaemia, we are pleased to be working closely with the Thalassaemia International Federation. The collaboration will give Kiadis Pharma the opportunity to obtain valuable scientific feedback, advice and support in further developing innovative treatments for thalassaemia patients.”
Androulla Eleftheriou, Executive Director of Thalassaemia International Federation (TIF), added: “We look forward to working more closely with Kiadis Pharma. The collaboration will allow us to further expand on our ongoing educational and awareness programs supporting patients, carers and health care professionals in their efforts to successfully treat thalassaemia. The possibility of reducing the risks of HSCT will allow the cure of a greater number of patients, satisfying the very existence of TIF.”
About Thalassaemia International Federation
The Thalassaemia International Federation (TIF) is a non-profit, non-governmental umbrella organisation founded in 1986 by a small group of patients and parents representing mainly National Thalassaemia Associations in Cyprus, Greece, UK, USA and Italy – countries where thalassaemia was first recognised as an important public health issue and where the first programmes for its control, including prevention and clinical management, began to be promoted and implemented. TIF’s membership today includes 190 members from 61 countries. TIF works in official relations with the World Health organisation (WHO) since 1996 and with a number of other official health bodies and patient oriented organisations. TIF’s mission is to promote optimal quality care for all patients with thalassaemia worldwide. More information is available at www.thalassaemia.org.cy.
About Kiadis Pharma
Kiadis Pharma is a clinical stage biopharmaceutical company focused on research, development and future commercialisation of cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company believes that its innovative products have the potential to address the current risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), being graft-versus-host disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders and the Company expects that HSCT could become a first-choice treatment for blood cancers and inherited blood disorders once current risks and limitations are addressed, thereby meeting a significant unmet medical need with its products.
Currently, the Company’s product ATIR101™ is being tested using a single dose regimen in an open-label Phase II trial in patients with blood cancer who have not found a matching donor and where a partially matched (haploidentical) family member is used as donor for HSCT. Kiadis Pharma announced full enrolment of this trial in July 2015. The primary endpoint for the last patient in this trial will be reached at the end of Q1, 2016, top-line results to follow at the beginning of Q2, 2016.
In addition, the Company is enrolling blood cancer patients in a further Phase II clinical trial to study the safety and efficacy of administrating a second dose of ATIR101™ to further improve the HSCT outcome.
The European Medicines Agency (EMA) has issued an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data to the Company, and to date Kiadis Pharma is one of only five companies that have received such a certificate.
ATIR101™ has been granted Orphan Drug Designations both in the US and Europe.
ATIR201™ will be developed for inherited blood disorders with an initial focus on thalassaemia, an inherited blood disorder which results in improper oxygen transport and destruction of red blood cells in a patient. ATIR201™ is expected to enter clinical development for thalassaemia with a Phase I/II trial in the first quarter of 2016.
Kiadis Pharma is based in Amsterdam, the Netherlands and its shares are listed on Euronext Amsterdam and Euronext Brussels.
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For more information, please contact:
Manfred Rüdiger, CEO
1114 AA Amsterdam-Duivendrecht
Tel. +31 20 314 02 50
International Media and Investor Contact:
Mary-Jane Elliott, Lindsey Neville, Hendrik Thys
Consilium Strategic Communications
Tel: +44 (0) 203 709 5708
Forward Looking Statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect Kiadis Pharma’s or, as appropriate, Kiadis Pharma’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, Kiadis Pharma expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither Kiadis Pharma nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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