European Medicines Agency approves Orphan Medicinal Product application of DCPrime's Acute Myeloid Leukemia vaccine
February 1, 2012 - Biotechnology company DCPrime today announces that the Committee for Orphan Medical Products (COMP) of the European Medicines Agency has issued a positive opinion recommending DCPrime's application for orphan drug designation of, the company's dendritic cell-based cancer vaccine candidate, which targets Acute Myeloid Leukemia (AML).
Major step towards approval of vaccine
"This orphan drug designation is a major step in DCPrime's work towards approval of our AML vaccine, and clearly reflects the COMP's view of the potential of this vaccine in improving survival of patients with AML", said DCPrime's CEO and CSO Dr. Ada Kruisbeek. "At the present time, AML patients lack an approved therapy to prevent the cancer from returning after standard chemotherapy. In 75% of the patients treated, the leukemia returns within 2 years. Our vaccine is intended as a therapy to prevent the cancer from coming back, and in our current clinical study we are establishing if we can delay or prevent AML from returning. If we succeed, this will improve survival outcomes in AML."
Orphan drug designation
Orphan drug designation is granted to products aimed at treatment of a rare disease or condition that affects fewer than 5 per 10,000 people in the European Community. As a result, DCPrime will be eligible to receive a number of benefits, including valuable scientific advice to optimize development and guidance on clinical design, and extended allowance for marketing exclusivity after the drug's approval for a period of up to ten years. Orphan drugs are eligible to full (100%) reduction of fees associated with protocol assistance, pre-authorization inspections, as well as full reduction of marketing application fees and annual fees.
DCPrime is a Dutch clinical stage company, dedicated to developing cancer vaccines based on its proprietary dendritic cell (DC) technology platform DCOneTM. With this platform, the company can generate off-the-shelf DC-based vaccines for a broad range of cancer types. DCOneTM-based DC vaccines share all immune-stimulatory properties with patient derived DC-based vaccines, and have the simple logistics of off-the-shelf products. A commercial scale manufacturing process to produce DCOneTM-based vaccines has been developed, and DCPrime's lead product DCP-001 is in the clinic in a Phase I/IIa study in patients with Acute Myeloid Leukemia (AML). Several products for solid cancers are in preclinical development, using peptide loaded DCOneTM-based vaccines. With this powerful platform, DCPrime has the opportunity to become the gold standard for off-the-shelf dendritic cell products.
About the committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products (COMP) is responsible for reviewing applications from persons or companies seeking 'orphan medicinal product designation' for products they intend to develop for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons in the European Union. The COMP is also responsible for advising the European Commission on the establishment and development of a policy on orphan medicinal products in the EU, and assists the Commission in drawing up detailed guidelines and liaising internationally on matters relating to orphan medicinal products.
For more information or to request further updates, please contact:
Prof. Dr. Ada Kruisbeek, PhD
Chief Executive and Scientific Officer
Telephone : +31 (0)20 - 5985601
Mobile: +31 (0)6 - 55172158
Email: [email protected]
Chief Business Officer
Telephone: +31 (0)20 - 5985601
Mobile: +31 (0)6 - 11757250
Email: [email protected]
De Boelelaan 1085 (W&N, F546)
1081 HV Amsterdam