Date:3/15/2013

rome (MDS).  Orphan designation grants potential US market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval.  Additional potential benefits of orphan designation include development grants, tax credits related to clinical trial expenses, protocol development assistance and exemption from FDA user fees. 

Results of clinical trials with Telintra were reported in peer reviewed medical publications including:

"Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS)," Raza, A., et al., Journal of Hematology & Oncology 2012, 5:18 doi:10.1186/1756-8722-5-18; 30 April 2012. Significant findings of the study included multilineage responses and good tolerability, supporting the further development of the Telintra and Revlimid® combination in MDS as well as in other hematologic malignancies where Revlimid is a standard of care.

"Prediction of response to therapy with ezatiostat in lower risk myelodysplastic syndrome," Galili, N. et al., Journal of Hematology & Oncology 2012, 5:20 doi:10.1186/1756-8722-5-20; 6 May 2012. A gene marker analysis was performed using RNA available from 30 patients enrolled in a Phase 2 Telintra clinical trial. Pathway analysis of the response profile revealed that the genes comprising the jun-N-terminal kinase/c-JUN molecular pathway, which is known to be influenced by Telintra, were under-expressed in responders and over-expressed in non-responders, providing additional support for the novel mechanism of action of Telintra and a potential basis for a companion diagnostic.

"Oral Ezatiostat HCl (Telintra), a Glutathione Analog Prodrug GSTP1-1 Inhibitor, for Treatment of Patients with Myeloid Growth Factor-Resistant Idiopathic Chronic Neutropenia (ICN)," by '/>"/>

SOURCE Telik, Inc. Copyright©2012 PR Newswire. All rights reserved

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