By Nate Chongsiriwatana --
Hana
Biosciences, Inc. recently announced that it received a Notice of
Allowance from the U.S. Patent and Trademark Office for U.S. Application No. 11/886,803, entitled "Vitamin
K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" (U.S. Patent Application Publication No. 2009/0209652 A1). Skin rash is a painful and common side effect of all approved epidermal growth
factor receptor (EGFR) inhibitors (such as Tarceva®, Iressa®, Erbitux®,
Vectibix®, and Tykerb®) that can limit treatment or make dose reduction
necessary. As its title suggests, the '803 application discloses treatment of
EGFR-associated skin rash with vitamin K3 (also known as menadione), a
provitamin precursor of vitamin K2. Once issued, the patent will extend
protection for this technology into 2026. Corresponding foreign
applications are pending in Australia, Canada, Europe, Hong Kong, Japan, and
Korea, and Hana reports that additional applications relating to the use of
menadione have been filed.
The sole independent claim allowed in the '803 application reads:
1. A method for treating a skin rash secondary to an anti-epidermal growth
factor receptor (EGFR) therapy in a subject receiving said therapy, the method
comprising applying vitamin K3 to the skin in an amount effective to treat the
skin rash.
A Phase I clinical study conducted by Hana demonstrated that a menadione
topical lotion was generally well-tolerated, and that menadione was delivered
into the skin without appreciable systemic absorption. Recently, Hana completed
enrollment for a proof-of-concept study of vitamin K3 lotion in cancer patients
receiving EGFR inhibitor therapy; the company expects to present data from this
study and initiate a Phase II trial by the end of 2010.
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