NEW HAVEN, Conn., Feb. 17 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for its lead oncology therapeutic Onrigin (laromustine) Injection as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). The Company has requested a priority review for the application and, if granted, Onrigin could receive approval for this indication in the second half of 2009.
Alan Kessman, Chief Executive Officer, commented, 'This NDA filing is a significant milestone for Vion and for the Onrigin clinical development program. Acute myeloid leukemia is a devastating disease, and patients and their physicians are seeking new treatment options that can provide the opportunity for achieving a complete response.' He concluded, 'We are excited to be taking this major step towards achieving FDA approval for Onrigin.'
The Onrigin NDA submission is based on the results of an international multi-center pivotal Phase II trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eighty-six percent of these patients had two or more risk factors that predicted for a poor prognosis. The Company presented data on this group of patients in a poster at the American Society of Hematology (ASH) Annual Meeting in December 2008.
Dr. Frank Giles, Chief of the Division of Hematology and Medical Oncology and Deputy Director of the Cancer Therapy & Research Center at the University of Texas Health Science Center at San Antonio commented, 'If approved, Onrigin would represent an important new treatment option for elderly AML patients, many of whom now have no effective therapeutic options. Onrigin's ability to generate meaningful complete responses after a single sixty-minute infusion makes its utility in this patient population particularly attractive.'
About Onrigin
Onrigin (laromustine) Injection, formerly known as Cloretazine(R) (VNP40101M), is a novel alkylating agent. Onrigin has been evaluated in over 800 patients in 16 clinical trials to date, including a pivotal Phase II trial in patients sixty years of age or older with de novo poor-risk AML.
