Overview Marqibo® Alocrest™ Brakiva™ Menadione Topical Lotion Hana Clinical Trials Publications Presentations		Menadione Topical Lotion A Topical Compound for Skin Rash Associated with Epidermal Growth Factor Receptor Inhibitors (EGFRI) Treatment with EGFR inhibitors such as Tarceva®, Erbitux® and Vectibix® are associated with an acne-form rash involving the face, neck and upper torso in approximately 75% patients. 50% of patients who manifest skin toxicity experience significant discomfort. This results in drug discontinuation or dose reduction in at least 10% and up to 30% of all subjects. Menadione Topical Lotion is designed to mitigate or prevent the rash by restoring or preserving the normal EGFR signaling in skin. Drug delivery is targeted to the normal location of the EGFR-containing skin cells at the dermal/epidermal junction without interfering with EGFR inhibition systemically at the level of the tumor. Preclinical data support the potential for topical menadione to prevent and/or treat EGFR inhibitor rash: Inhibits phosphatase activity and sustains EGFR activity Functions as an EGFR tyrosine kinase (TK) activator in skin Can rescue EGFR TK function in skin cells treated with Erbitux® or Tarceva® Ongoing and planned trials to lead towards FDA approval: Phase 1 safety, tolerability, bioavailability study in the treatment of patients receiving EGFR inhibitors for anti-cancer therapy in both rash emergent and rash pre-emergent settings is ongoing Initiation of randomized Phase 2 trial likely beginning early 2009 Ongoing Trials Phase 1: Tolerability and Systemic Absorption of Menadione Topical Lotion for Epidermal-Growth-Factor-Receptor (EGFR) Inhibitor-Associated Rash Publications ESMO 2008 ASCO 2007 ASCO 2006 For further information on our product pipeline and/or business development inquiries please contact the Business Development Department.
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