USPTO issues Notice of Allowance for menadione to prevent skin rash in patients taking EGFR inhibitors

Mar 31 2010

Hana Biosciences (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux® and Tarceva®, for anti-cancer therapy. The U.S. Patent Application Number 11/886,803 is entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" and extends intellectual property protection around menadione into 2026. The Company also has a similar patent application for menadione co-pending in Australia, Canada, Europe, Hong Kong, Japan, and Korea. Additional applications extending the use of menadione have been filed.

"This Notice of Allowance reinforces our commitment to developing topical menadione as a first‐in‐class therapeutic targeted at the dose-limiting skin toxicities in patients taking EGFR inhibitors," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "The majority of patients taking EGFR inhibitors develop a skin rash, which leads to delay, reduction and even discontinuation of EGFR inhibitor therapy in a substantial percentage of patients. Currently, there are no approved treatments available."

Hana has completed a Phase 1 study of menadione topical lotion in healthy volunteers, which demonstrated delivery of menadione into the skin without appreciable systemic absorption. In addition, menadione topical lotion was generally well-tolerated. The Company has recently completed enrollment of a proof-of-concept study of menadione topical lotion in cancer patients receiving EGFR inhibitors for anti-cancer therapy. This study assessed both treatment potential in patients with new onset rash and prophylactic potential in those about to begin an EGFR inhibitor. The Company expects to present the proof-of-concept data and initiate a randomized Phase 2 trial by the end of 2010.

Rash is a common, painful and treatment-limiting skin toxicity side effect of all approved EGFR inhibitors (e.g. Tarceva®, Iressa®, Erbitux®, Vectibix®, Tykerb®) with incidence rates as high as 90 percent.  EGFR inhibitor-associated rash can lead to reduced compliance and cause dose reductions, delays or discontinuation of EGFR inhibitor therapy in a significant portion of affected patients.  Currently, there are no products or therapies FDA-approved to treat these skin toxicities.