The study demonstrated that 77% of patients who were treated for at least six months with chlormethine gel achieved a clinical response in the Composite Assessment of Index Lesion Severity (CAILS) score, while 59% of those treated with the compounded control had a clinical response.
Actelion Ltd (VTX: ATLN) has been granted marketing authorisation from the European Commission (EC) for Ledaga (chlormethine) for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL), the company revealed on Wednesday.
M2 PHARMA-January 19, 2012-Ceptaris gets EMA Orphan Drug Designation for chlormethine gel for CTCL(C)2012 M2 COMMUNICATIONS
19 January 2012 - US speciality pharmaceutical firm Ceptaris Therapeutics Inc said on Wednesday it had received Orphan Drug Designation from the European Medicines Agency (EMA) for its investigational product chlormethine gel for the treatment of Cutaneous T-Cell Lymphoma (CTCL).
Multiple treatments exist for early MF such as topical corticosteroids, topical chlormethine, or phototherapy .
A Folliculotropic Mycosis Fungoides was diagnosed in a 58-year-old male patient in 1997 and treated with local chlormethine between 1998 and 2006.
Technician Karen Beattie selected Chlormethine
instead of Carmustine while he was being treated for lymphoma.
The European Commission has granted marketing authorisation to Switzerland-based Actelion for its Ledaga (chlormethine gel) 160 micrograms/g intended to treat mycosis fungoides-type cutaneous T-cell lymphoma, it was reported yesterday.
In the randomised controlled study, around 77% of patients within the efficacy evaluable population who have been treated for around six months with chlormethine gel indicated a clinical response in the composite assessment of index lesion severity score, while 59% of those treated with the compounded control had a clinical response.