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Vion Pharmaceuticals Presents Updated Clinical Data from a Phase II,trial of Cloretazine (VNP40101M) in Patients with Relapsed or,Refractory Small Cell Lung Cancer

NEW HAVEN, Conn., June 04, 2007 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. announced that it presented updated clinical data in a poster session at the 43rd Annual Meeting of The American Society of Clinical Oncology (ASCO) on its lead anticancer agent Cloretazine(R) (VNP40101M) as a single agent in a Phase II trial in patients with relapsed or refractory small cell lung cancer.

The Phase II trial evaluates Cloretazine(R) (VNP40101M) in two separate subpopulations of small cell lung cancer: (i) sensitive relapse disease and (ii) refractory disease. Sensitive relapse disease is defined as relapse after three months of first-line therapy and refractory disease is defined as relapse within three months of first-line therapy. Data are presented on a total of 48 evaluable patients: (i) 20 patients in the sensitive relapse arm and (ii) 28 patients in the refractory arm.

Patients on the trial initially received 125 mg/m2 of Cloretazine(R) (VNP40101M) weekly for three weeks, every six weeks. This dose was later reduced by protocol amendment to 100 mg/m2 weekly for three weeks every six weeks due to the incidence of grade 3 and 4 thrombocytopenia at the initial dose level.

Of the 20 evaluable patients on the sensitive relapse arm, there have been 6 patients with partial response and one patient awaiting confirmation of response (overall, 35% response rate), and 3 patients have stable disease. Four of 13 sensitive relapse patients responded at the 125 mg/m2 dose level and 3 of 7 sensitive relapse patients responded at the 100 mg/m2 dose level. Of the 28 patients with refractory disease treated with Cloretazine(R) (VNP40101M), 1 patient achieved a partial response and 3 patients have demonstrated stable disease.

A total of 55 patients were evaluable for toxicity. Grade 3 and 4 thrombocytopenia was observed in 14 of 31 patients (45%) at the 125 mg/m2 dose level. Thrombocytopenia was su
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