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About Mycosis Fungoides (MF) and Cutaneous T-Cell Lymphoma (CTCL)

Mycosis fungoides is the most common type of Cutaneous T-Cell Lymphoma, a rare form of non-Hodgkin's lymphoma. The cause of mycosis fungoides remains unknown and there is no known cure. Unlike most non-Hodgkin's lymphomas, mycosis fungoides is caused by a mutation of T-cells. The malignant T-cells in the body initially migrate to the skin, causing various lesions to appear. These lesions typically begin as what appears to be a rash and may progress to form plaques and disfiguring tumors.

Early stage cases may be confused with other skin conditions until a definitive diagnosis is made based upon skin biopsy. Most cases of mycosis fungoides are early-stage and are diagnosed in patients over the age of 50.



Mechlorethamine gel is Ceptaris Therapeutics' investigational, proprietary topical formulation of mechlorethamine. Mechlorethamine is a chemotherapeutic agent previously approved for intravenous treatment of mycosis fungoides, the most common type of CTCL.

Topical mechlorethamine preparations are recommended for treatment of early stage CTCL by the National Comprehensive Cancer Network (NCCN)*. However, there are no FDA-approved topical mechlorethamine drugs, limiting its availability to non-standardized, pharmacist-compounded preparations. These preparations are typically either aqueous- or paraffin- (petroleum jelly) based formulations. Paraffin-based formulations are extremely greasy and inconvenient.

Ceptaris' proprietary mechlorethamine gel is a novel formulation that has been standardized and made under Good Manufacturing Practices (GMPs). A pivotal multi-center clinical study of this topical mechlorethamine gel in patients with early stage mycosis fungoides, a type of CTCL, met its primary and secondary endpoints. The primary endpoint was an assessment of lesion severity. Adverse events potentially related to Ceptaris' formulation include dermatitis (skin irritation, pruritus and erythema) and hyperpigmentation. Dermatitis ranged from mild to moderately severe. Based on these results, Ceptaris submitted a New Drug Application (NDA) to the FDA in July 2011. Ceptaris' mechlorethamine gel has been granted Fast Track Status and Orphan Drug Status by the FDA.

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