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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.
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ABOUT INVESTIGATIONAL DRUG: Mechlorethamine Gel
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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