NDA for gel-based topical mechlorethamine hydrochloride for treating early-stage mycosis fungoides was recently submitted.
Yaupon Therapeutics raised $14.4 million through a Series D private placement with new and existing investors. The funds will be used to support regulatory review and potential commercialization of Yaupon’s lead compound, a proprietary gel formulation of mechlorethamine hydrochloride, for the treatment of early-stage mycosis fungoides, the most common type of cutaneous T-cell lymphoma (CTCL). The firm submitted its NDA for the product toward the end of July.
“This financing provides us with the necessary capital to take us through the NDA regulatory review process, while preparing for commercialization either alone or with an industry partner,” remarks chairman and CEO Steve Tullman.
Mechlorethamine is a chemotherapeutic agent that is approved in an intravenous formulation for treating mycosis fungoides, Yaupon notes. However, although topical mechlorethamine preparations are recommended for the treatment of early-stage CTCL by the National Comprehensive Cancer Network (NCCN), there are currently no FDA-approved topical preparations. Consequently, topical treatment with mechlorethamine is limited to nonstandardized, pharmacist-compounded preparations that are often paraffin-based.
In contrast, Yaupon’s water-based mechlorethamine topical gel is cGMP-manufactured and has been evaluated in clinical studies. In a pivotal study in patients with early-stage mycosis fungoides the product met both the primary endpoint of lesion severity and secondary endpoints. The topical gel has been granted fast-track and orphan drug status by FDA.