ASH News Daily - Sunday, December 11, 2011 - (Page B-35)

Expanded access study now enrolling Investigating ruxolitinib* An oral JAK1 and JAK2 inhibitor in patients with PMF, PPV-MF, or PET-MF Screen Day -28 to -1, 950 patients with PMF, PPV-MF, or PET-MF Therapy 28-day treatment cycles, ruxolitinib 15 mg to 20 mg orally BID † Follow-up 28 days post end of treatment † Patients will receive study drug until one of the following occurs: disease progression, unacceptable toxicity, death, discontinuation from the study for any other reason, until the drug becomes commercially available in each participating country, or until 24 months after LPFV. Primary Endpoint Safety and tolerability assessed by frequency, duration, and severity of AEs Select Eligibility Criteria‡ • Age ≥18 years • Must have a diagnosis of PMF PPV-MF or PET-MF , , • Patients may or may not have had prior treatment with commercially available agents • Peripheral blood blast count <10% • Platelet count >100,000/µL • Adequate liver function, defined as direct bilirubin ≤2.0 x ULN and ALT ≤2.5 x ULN • Adequate renal function, defined as serum creatinine ≤2.0 x ULN • ECOG performance status of 0, 1, or 2 ‡ Additional eligibility criteria apply. For more information or to enroll a patient outside the United States, please contact your local Novartis Medical Science Liaison, visit www.jumptrial.com or use the QR code below. This information is intended for healthcare professionals outside the United States. Protocol No. CINC424A2401 *Ruxolitinib is investigational. Efficacy and safety have not been established. There is no guarantee that ruxolitinib will become commercially available. Abbreviations: AE, adverse event; ALT, alanine aminotransferase; BID, twice a day; ECOG, Eastern Cooperative Oncology Group; JAK, Janus kinase; LPFV, last patient first visit; PET-MF, post-essential thrombocythemia myelofibrosis; PMF, primary myelofibrosis; PPV-MF, post-polycythemia vera myelofibrosis; ULN, upper limit of normal. 2 x J C X How to: OR Scan QR code with your smartphone app to view the Web site. Take a picture of QR code using your phone, e-mail it to Novartis@jagtag.com, and receive requested URL via e-mail. Novartis Pharmaceutical Corporation East Hanover, NJ 07936 PDF PDF ©2011 Novartis 10/11 ONC-1031826 INCF16527_JrnlAd_US_ASH_DailyNews_DR2.indd 1 10/26/11 5:13 PM

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ASH News Daily - Sunday, December 11, 2011

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