Kiadis Pharma Announces Full Enrolment of its Phase II Clinical Study with Lead Product, ATIR101™
AMSTERDAM–(BUSINESS WIRE)– NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES (INCLUDING ITS TERRITORIES AND POSSESSIONS, ANY STATE OF THE UNITED STATES OR THE DISTRICT OF COLUMBIA), AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA OR ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION.
Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Euronext Brussels: KDS), a recently listed clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces full enrolment of patients into its ongoing Phase II clinical study with its lead product, ATIR101™.
ATIR101™ is a cell-based product designed to enable stem cell transplantations from partially matched (haploidentical) family donors for blood cancer patients who do not have a matching stem cell donor available. The ongoing Phase II study with ATIR101™ is an international multi-centre study in which a total of 23 leukaemia patients, including patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL) and myelodysplastic syndrome (MDS), will be enrolled and treated with ATIR101™ as part of their transplant regimen.
The primary endpoint of the study is the rate of Transplant Related Mortality (TRM) at six months after allogoneic hematopoietic stem cell transplantation (HSCT). To date, 21 out of the 23 enrolled patients have received their HSCT, 19 of which have also been dosed with ATIR101™. The remaining patients are at various stages of treatment, either being prepared for HSCT or being dosed with ATIR101™. The 23 rd patient is expected to undergo treatment with ATIR101™ in Q3 2015 and the study will remain open for enrolment until this final patient has been treated. Read-out of the primary endpoint results is expected in Q1 2016.
Dr. Jeroen Rovers, Chief Medical Officer of Kiadis Pharma, said: “We are grateful to all investigators in Canada, Belgium, Germany and the UK for collaborating with us and assisting us with the enrolment of patients into this study. We will continue to work with them in order to provide the best care possible for all patients involved in the study. We would also like to thank the patients, donors and their families for their participation.”
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “Full enrolment into the study is an important milestone for Kiadis Pharma and one which we set out to achieve as stated at the time of our recent successful IPO. The study has been progressing well since the publication of the positive interim data at ASH in 2014 and we expect read-out on the primary endpoint, Transplant Related Mortality at six months after HSCT, to be available in the first quarter of 2016. Reaching this enrolment target brings us one step closer to bringing our lead product, ATIR101™, to the market and to the thousands of blood cancer patients who are in need of a transplant.”
Interim data from a pre-specified interim analysis in this study were presented by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and Chair of the study, at the 2014 American Society of Hematology (ASH) Annual Meeting in San Francisco. These data confirmed the safety of ATIR101™ administration with no grade III-IV (life-threatening) acute Graft versus Host Disease (GVHD) occurring, despite the fact that no prophylactic immune suppressants were used. Only a limited number of grade I-II GVHD events were reported, all of which were treated successfully. Furthermore, no relapses were reported in any of the first ten patients, with four out of the ten patients in follow-up for more than one year at the time of the interim analysis. These data are in line with the data previously reported from Kiadis Pharma’s Phase I/II study with 19 patients.
About ATIR™
During an allogeneic hematopoietic stem cell transplantation (HSCT) treatment, the bone marrow, harbouring the diseased cells, is completely destroyed and subsequently replaced by stem cells from a healthy donor. After an HSCT treatment it usually takes at least six to twelve months to recover to near-normal blood cell levels and immune cell functions in a patient that has received a transplant. During this period, the patient is highly susceptible and vulnerable to infections caused by bacteria, viruses and fungi. Immune cells in ATIR ™ (Allodepleted T-cell ImmunotheRapeutics) will help fight these opportunistic infections and bridge the time until the immune system has fully re-grown from stem cells in the transplanted graft.
In ATIR ™, T-cells that cause Graft-versus-Host-Disease (GVHD) are eliminated from the donor lymphocytes, which minimises the risk of GVHD and any related morbidity and mortality. At the same time, ATIR ™ contains potential cancer killing T-cells from the donor that could eliminate residual cancer cells and avoid the return of the disease. ATIR ™ allows the use of haploidentical grafts that are almost entirely depleted of T-cells, which eliminates the need for immunosuppressive drugs. ATIR ™ subsequently provides the patient with immune cells that do not cause GVHD. As a result, ATIR ™ solves the problem of not finding a matched donor in time and has the potential to make curative HSCT a viable option to many more patients.
The Company estimates that approximately 35% of patients who are eligible for, and who are in urgent need of, HSCT will not find a matching donor in time. A partially matched (haploidentical) family donor, however, will be available to over 95% of patients. The use of haploidentical donor grafts without ATIR™ is only feasible in conjunction with severe immunosuppression which renders the patient highly vulnerable to infections with severe clinical complications, resulting potentially in death.
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). Although currently not a viable option for many patients, HSCT is generally regarded as the most effective curative approach to blood cancers and certain inherited blood disorders. 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, ATIR™101 is being tested 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 is based in Amsterdam, the Netherlands and its shares were admitted to listing and trading on Euronext Amsterdam and Euronext Brussels on 2 July 2015. Further information can be found at: www.Kiadis.com
This press release contains regulated information ( gereglementeerde informatie) within the meaning of the Dutch Financial Supervision Act ( Wet op het financieel toezicht) which must be made publicly available pursuant to Dutch law. This press release is intended for information purposes only.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150729006494/en/
Contacts
Kiadis Pharma
Manfred Rüdiger, CEO
Tel. +31 20 314 02 50
communication@kiadis.com
or
< b>International Media and Investor Contact:
Consilium Strategic Communications
Mary-Jane Elliott, Lindsey Neville, Hendrik Thys
Tel: +44 (0) 203 709 5708
kiadis@consilium-comms.com