* Preclinical study evaluating a clinically relevant model of normal human skin found that Menadione was the only agent capable of abrogating the cytotoxic effect of erlotinib * Phase I single agent Marqibo(r) showed OPTISOME(tm) agent was generally well tolerated in metastatic melanoma patients with an adverse event profile similar to conventional vincristine
SOUTH SAN FRANCISCO, Calif., June 4, 2007 (PRIME NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on advancing cancer care, today announced the presentation of data for Menadione and Marqibo(r) (vincristine sulfate injection, OPTISOME(tm)) at the 43rd Annual American Society of Clinical Oncology (ASCO) Annual Meeting.
"We are pleased to have the opportunity to share data regarding our emerging anti-cancer compounds at ASCO this year. Dr. Perez-Soler presented promising preclinical data showing that Menadione may be a useful topical agent in the treatment of the rash associated with EGFR inhibitors," stated Steven R. Deitcher, M.D., Hana Bioscience's Executive Vice President of Development and Chief Medical Officer. "Marqibo again showed that it is an active drug in another difficult-to-treat histology, namely metastatic melanoma. We are looking forward to further development of Menadione, Marqibo, and the other promising drug candidates in our pipeline."
Menadione is a topical agent being developed by Hana to treat skin rashes associated with use of Epidermal Growth Factor Receptor (EGFR) inhibitors. Skin toxicity is one of the most common side effects of EGFRs and is observed with the three approved agents of this class: cetuximab (Erbitux(r); Bristol-Myers Squibb/Imclone), panitumumab (Vectibix(r); Amgen), and erlotinib (Tarceva(r); Genentech/OSI). A preclinical study evaluating a clinically relevant model of normal human skin found that Menadione was the only agent capable of abrogating the cytotoxic effect of erlotinib. In contrast, researchers found that steroids and immunosuppressive agents may potentiate the cytotoxic effect of anti-EGFR inhibitors in the skin, thus providing a possible explanation for the erratic and mixed therapeutic results often observed with the use of these agents. This data was presented by Roman Perez-Soler, M.D., Chief of the Division of Oncology in the Department of Medicine at the Albert Einstein College of Medicine in New York in an abstract titled "Steroids and immunosuppressive agents potentiate the cytotoxicity of the EGFR inhibitor erlotinib (E) in human skin keratinocytes whereas Menadione (Vit K3) exerts a protective effect: implications for the management of the skin rash" (#9124).
Results from a Phase I, single-center, open-label, randomized, 2-arm crossover study of Marqibo in Stage III or IV melanoma patients were presented in an abstract titled "A pharmacokinetic comparison of the Marqibo 3- and 5- vial injection kits in metatastic melanoma patients" (#8575) by members of the study team lead by Dr. Agop Bedikian of the UT MD Anderson Cancer Center in Houston. The study showed that the 3- and 5- vial kits produced a bioequivalent pharmacokinetic (PK) profile. Single agent Marqibo was also generally well tolerated in metastatic melanoma patients with an adverse event profile similar to conventional vincristine. In addition, Marqibo showed promising single agent activity against Stage IV metastatic melanoma. Hana is currently developing Marqibo for use in the treatment of patients with acute lymphoblastic leukemia.
About Menadione
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 non-small cell lung cancer, pancreatic, colorectal, and head & neck cancer. Approximately seventy-five percent 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. Following the completion of non-clinical studies with Menadione, Hana plans to submit an Investigational New Drug application by the end of 2007.
About Marqibo(r) (vincristine sulfate injection, OPTISOME(tm))
Marqibo, a novel, targeted, Optisomal formulation of vincristine, has shown promising anti-cancer activity in patients with non-Hodgkin's lymphoma (NHL) and acute lymphoblastic leukemia (ALL) clinical trials. Vincristine, a microtubule inhibitor, is FDA-approved as a single agent and in combination regimens for the treatment of hematologic malignancies such as lymphomas and leukemias. Vincristine kills cancer cells when they enter a very specific point in the cell cycle -- and its efficacy is concentration- and time-dependent. Marqibo extends circulation time of vincristine in the bloodstream and subsequently increases targeting of the drug to the tumor site. Marqibo allows for a significant increase in the dose of the active ingredient as opposed to the dose of the conventional vincristine. The FDA granted Marqibo Orphan Drug Designation for the treatment of adult ALL.
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 advance cancer care. The company is committed to creating value by building a world-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.
The Hana Biosciences, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3290
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 results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Hana's product candidates, including its Optisomal product candidates and Menadione. 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, 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 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, 2006 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.