AMSTERDAM, May 13, 2015 /PRNewswire/ --
Kiadis Pharma B.V. ("Kiadis Pharma" or "the Company"), a clinical stage biopharmaceutical company developing innovative immunotherapy treatments, today announces that its lead product ATIR™ for blood cancers has been granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA).
The granted ATMP certificate was issued on a recommendation from the Committee for Advanced Therapies of the EMA recognizing that the data generated for ATIR™ is meeting the stringent standards imposed by the agency. As of 2009, only five such ATMP certificates have been issued by the EMA.
The certification procedure aims at a full evaluation of the complete manufacturing quality and pre-clinical data package ahead of marketing authorization. The granted certificate confirms that the data submitted for an ATMP meet the scientific and technical standards that apply for evaluating a Marketing Authorization Application (MAA) by the EMA. This procedure and the granted certificate will thus facilitate the preparation, filing and evaluation of a future MAA for ATIR™.
Manfred Rüdiger, CEO of Kiadis Pharma, commented: "We are pleased that the data for our lead product ATIR™ meet the stringent EMA requirements. This certification is a testament to the high standards and quality levels now employed at Kiadis Pharma and we are very proud that the EMA has acknowledged this. It represents another important milestone in the development of ATIR™ as we continue to progress the ongoing Phase II study."
About Kiadis Pharma
Kiadis Pharma is a private 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 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™ 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 supported by a strong group of leading international investors including LSP, Alta Partners, DFJ Esprit, Quest for Growth, MedSciences Capital and NOM. Kiadis Pharma is based in Amsterdam, The Netherlands. Further information can be found at: http://www.kiadis.com
During HSCT treatment the bone marrow, harbouring the diseased cells, is completely destroyed and subsequently replaced by stem cells from a healthy donor. After HSCT it usually takes at least six to twelve months to recover to nearly 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 by bacteria, viruses and fungi. Immune cells in ATIR™ (Allodepleted T-cell ImmunotheRapeutics) will help fight these opportunistic infections 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, avoiding the occurrence of this disease 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.
The Company has estimated that currently approximately 35% of patients who are eligible for, and who are in urgent need of, HSCT will not find a matching donor in time whereas a partially matched (haploidentical) family donor will be available to over 95% of people. However, the use of haploidentical donor grafts is only feasible in conjunction with severe immunosuppression which renders the patient highly vulnerable to infections.
ATIR™ allows the use of completely T-cell depleted haploidentical grafts, eliminating the need for immune suppressive drugs and providing the patient with immune cells that will not cause GVHD. Thereby, 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.
Manfred Ruediger, CEO
1114 AA Amsterdam-Duivendrecht
Media and Investor Contact:
Mary-Jane Elliott, Jessica Hodgson, Lindsey Neville, Hendrik Thys
Consilium Strategic Communications
SOURCE Kiadis Pharma