MolMed experiences during Phase I/II and how we are moving to marketing authorisation during Phase III.
- Resource Type
- Article
- Authors
- Dieci, Marco
- Source
- Pharmaceuticals Policy & Law. 2010, Vol. 12 Issue 1/2, p143-145. 3p. 2 Diagrams.
- Subject
- *CELLULAR therapy
*ORPHAN drugs
*STEM cell transplantation
*LEUKEMIA
*DRUG efficacy
*PATIENTS
- Language
- ISSN
- 1389-2827
MolMed developed a TK cell based therapy to enable safe and effective haematopoietic stem cell transplantation (HSCT) from partially compatible donors (haplo-HSCT), currently in clinical development for high-risk leukaemia patients (AML and ALL). TK acquired the Orphan Drug status in EU (2003) and in US (2005). [ABSTRACT FROM AUTHOR]