SOUTH SAN FRANCISCO, Calif., April 7, 2008 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that active cancer patient dosing has commenced in the company's Phase 1 clinical trial of topical menadione lotion for the treatment and/or prevention of the rash associated with Epidermal Growth Factor Receptor Inhibitors (EGFRIs). Currently, there are no products or therapies approved by the U.S. Food and Drug Administration (FDA) to treat this pervasive skin toxicity that may cause the reduction, interruption or discontinuation of the EGFRI treatment.
"EGFRIs have proven to be very effective in the fight against numerous types of cancer and are used in over 100,000 patients annually. However, a majority of patients develop the rash associated with these therapies, affecting their quality of life and leading to possible reduction or cessation of their anticancer therapy, which can affect survival. I am excited to work with Hana Biosciences in the clinical evaluation of topical menadione, which may have the potential to offer relief from this terrible side-effect to patients during their cancer treatment," said Mario Lacouture, M.D., Assistant Professor of Dermatology at Northwestern University's Feinberg School of Medicine, and the principal investigator for this study.
"Initiating this Phase 1 trial of menadione represents an important opportunity for Hana Biosciences. It is a first-in-class, locally-targeted formulation that may play a major role in the management of a large and growing population of cancer patients. The ability to obtain patient data so early in development will help us to push forward with an aggressive development timeline," stated Steven R. Deitcher, M.D., President and CEO of Hana Biosciences. "We look forward to working with Dr. Lacouture and other investigators in this Phase 1 clinical study and potentially reach proof-of-concept in the second half of this year."
The primary objective of the Phase 1 study is to evaluate the systemic absorption of menadione topical lotion as an emergent and pre-emergent (prophylactic) treatment for EGFR inhibitor-associated rash. Additionally, the study will evaluate the efficacy and safety of menadione topical lotion in both treatment emergent and prophylaxis patients. The Phase 1 trial is designed to enroll a total of 24 adult subjects who are about to begin treatment with an approved EGFRI for cancer. Subjects will be divided into two cohorts, run sequentially. The first cohort will consist of subjects who develop the first signs and symptoms of EGFRI-associated rash on the face, neck, and/or upper chest following the initiation of their cancer treatment. In the second cohort, subjects will receive menadione lotion prophylactically, starting one day prior to beginning their EGFRI therapy. In both cohorts, subjects will serve as their own control and apply menadione lotion on one side of the treatment area and placebo lotion on the other side, in a blinded fashion. Treatment duration will last approximately one month.
There are currently four approved EGFRIs on the market: cetuximab (Erbitux(r); Bristol-Myers Squibb/Imclone), panitumumab (Vectibix(tm); Amgen), erlotinib (Tarceva(r); Genentech/OSI Pharmaceuticals), and gefitinib (Iressa(r); AstraZeneca). For Hana's Phase 1 study, there are no restrictions on the brand of EGFRIs administered to patients.
The Phase 1 clinical trial is currently open and enrolling in Chicago, Illinois at Northwestern University's Feinberg School of Medicine by Dr. Mario Lacouture.
About Menadione Topical Lotion
Menadione, a small organic molecule, has been shown to activate the Epidermal Growth Factor Receptor (EGFR) signaling pathway by inhibiting phosphatase activity. EGFR inhibitors, or EGFRIs, are currently used to treat over 100,000 patients per year with a variety of cancers including non-small cell lung cancer, pancreatic, colorectal, and head & neck cancer. The majority of patients taking EGFRIs develop an associated skin rash. Loss of EGFR signaling has been hypothesized as a mechanism of skin toxicity in patients receiving EGFRIs. In vitro studies have suggested that topically-applied menadione may restore EGFR signaling, specifically in the skin of patients treated systemically with EGFRIs. Currently, there are no FDA-approved products or therapies available to treat these skin toxicities. Hana Biosciences in-licensed topical menadione from the Albert Einstein College of Medicine in New York in October 2006.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (Nasdaq:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best in-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
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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 the clinical development, regulatory processes, potential clinical trial initiations, potential clinical benefits, potential IND and NDA filings and commercialization and partnering efforts relating to Hana's product candidates, including its Menadione product candidate. 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 its other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, 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 need to raise additional capital to fund its product development programs 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 Annual Report on Form 10-K for the year ended December 31, 2007 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.