Research: Menadione for EGFR-Assocoated Skin Rash

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http://www.primenewswire.com/newsroom/n ... l?d=139597

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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®; Bristol-Myers Squibb/Imclone), panitumumab (Vectibix; Amgen), erlotinib (Tarceva®; Genentech/OSI Pharmaceuticals), and gefitinib (Iressa®; 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.

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(News Release, Source: Hana Biosciences, Inc., South San Francisco, California, PrimeNewsWire, April 7, 2008 [Contains Forward-looking Statments])

Disclaimer:

The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.