Hana Biosciences Patent Issued For Menadione For The Prevention And Treatment Of EGFR Inhibitor Cancer Therapy-Associated Rash

SOUTH SAN FRANCISCO, Calif., July 8, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences, Inc. (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it was issued U.S. patent number 7,745,494, which covers a method of using menadione topical lotion in treating skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy. The issued patent extends patent protection around menadione into 2026. The Company also has related patent applications for menadione pending in Australia, Canada, Europe, Hong Kong, Japan, and Korea. Additional applications covering menadione and its use have been filed.

"We believe topical menadione has the potential to be an effective, first-in-class therapeutic specifically 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 anticipates unblinding this study in 2010.

Rash is a common, painful and treatment-limiting skin toxicity side effect of all approved EGFR inhibitors (e.g. Tarceva(R), Iressa(R), Erbitux(R), Vectibix(R), Tykerb(R)) 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 FDA-approved products or therapies to treat these skin toxicities.