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27 August 2010

New Chemotherapeutic Agents in Development: Vosaroxin (Voreloxin, SNS-595) by Sunesis Pharmaceuticals

A Review of Published Information of the Clinical Studies, the Proposed Phase 3 Program, the Competitive Environment in Acute Myeloid Leukemia and Commentary

Anastassios D. Retzios, Ph.D.

Abstract

Despite a recent strong emphasis in targeted therapies in cancer, there is still active development of chemotherapeutic agents that attack well-described cellular targets.  The advantage of this approach is that the target is validated by decades of development and practice and that incremental improvements can provide adequate justification for funding.  Sunesis Pharmaceuticals Inc., a South San Francisco-based biotechnology company, has been developing vosaroxin (formerly voreloxin or SNS-595), a topoisomerase II inhibitor, for the treatment of various solid and hematological cancers.  In the early phases of development the company tested the compound in advanced lung and ovarian cancer and in relapsed/refractory acute myeloid leukemia (AML).   Sunesis is currently planning to begin a Phase 3 study in relapsed/refractory AML in the 2nd half of 2010.  During the period of development of vosaroxin (the latter part of this decade), the share price of the company has steadily declined.  This report attempts to define if the current value of the stock accurately reflects a company which is set to enter the pivotal phase of development with its lead compound in an indication that, so far, lacks a definitive treatment choice.  In the pursuit of an answer to this question, this report examines the development process of vosaroxin by Sunesis, the design of the proposed Phase 3 study, the state of the art in the treatment of AML and ongoing research in this malignancy by other biotech or pharmaceutical companies.  The combined information may provide some answer regarding the market sentiment and assess if this sentiment is truly indicative of results thus far, the effectiveness and thoroughness of past performance and the likelihood of success in the future.  In a departure from similar efforts, this paper delves in the science and clinical studies of the cancers that comprised the targets of development for vosaroxin.

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