On December 3, 2015 Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) reported that it has initiated a Compassionate Use Program for vosaroxin. The Compassionate Use Program will be made available to eligible patients in the U.S. and selected European countries diagnosed with relapsed or refractory acute myeloid leukemia (AML) and will be managed by Clinigen Group plc’s (AIM:CLIN) Idis Managed Access (MA) division (Press release, Sunesis, DEC 3, 2015, View Source;p=RssLanding&cat=news&id=2119850 [SID:1234508393]). Clinigen Group plc’s (AIM:CLIN) Idis Managed Access (MA) division.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Vosaroxin is an investigational treatment and is currently not approved for use by any regulatory agency. Compassionate use programs are put in place to provide access to medicines for patients who have serious, or immediately life-threatening illnesses, and for whom no alternative treatment options are available. Access is provided in response to an unsolicited request from a physician for his/her patient with an unmet medical need.

"Sunesis is committed to providing patients and healthcare providers around the globe with more options for treating relapsed and refractory AML, a disease for which the standard of care has changed little in the last four decades," said Par S Hyare, VP Global Oncology Operations, Sunesis. "We are pleased to be working with Idis MA, a recognized leader in providing ethical access to medicines that address unmet needs and will be working towards gaining approval for vosaroxin in the U.S. and Europe for the treatment of relapsed and refractory AML."

Simon Estcourt, Managing Director of Idis Managed Access, Clinigen Group said: "AML is the most common acute leukemia affecting adults, with a very low survival rate, so there is a real need for new treatment options in these patients. By using our global logistical and regulatory expertise we will work with Sunesis and the AML community to provide ethical access to vosaroxin to help eligible patients who have no alternative treatment options."

For more information about Idis’ services and its Managed Access Programs, healthcare professionals may contact Idis via telephone on +44 (0)1932 824 135, fax on +44 (0)1932 824 335. To contact Idis by e-mail, U.S. physicians only use [email protected]. Physicians from all other countries please use [email protected].

About vosaroxin
Vosaroxin is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.