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.
About Hana Biosciences
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities, some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
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Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the benefits to be derived from Hana's drug development programs, including the potential advantages of its topical menadione lotion product candidate and its potential for use in the treatment of skin toxicities caused by the use of EGFR inhibitors, as well as the timing progress and anticipated results of the clinical development and regulatory processes concerning topical menadione lotion. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's development efforts relating to topical menadione lotion or its other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in its Form 10-Q for the three month period ended March 31, 2010, both as filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.