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Hana Biosciences Receives Notice of Allowance for Menadione Patent for the Prevention and Treatment of EGFR Inhibitor Cancer Therapy-Associated Rash
Tuesday, March 30, 2010
South San Francisco, CA -- 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.
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®, 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.
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 timing, progress and anticipated results of regulatory processes, including potential NDA filings and other regulatory submissions relating to Marqibo, and clinical development of Marqibo; and statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. 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 clinical and regulatory development efforts relating to Marqibo will be successful; that the data of the rALLy trial will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; and that the results of the rALLy trial and other clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, 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 Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on November 16, 2009. Hana assumes no obligation to update these statements, except as required by law.
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