Vion Reports Initial Data From Phase II Clinical Trial Of CLORETAZINE(TM) (VNP40101M) In Acute Myeloid Leukemia And Myelodysplastic Syndromes
DOW JONES NEWSWIRES
March 21, 2005 9:00 a.m.
NEW HAVEN, Conn. -- Vion Pharmaceuticals Inc. (VION) said it is encouraged with initial data from a Phase II clinical study of its anticancer agent Cloretazine.
In a press release Monday, the cancer-treatment pharaceutical company said the trial was designed to determine the response rate in treating acute myeloid leukemia and myelodysplastic syndromes.
The company noted patients in the first group of the study had acute myeloid leukemia or high-risk myelodysplastic syndrome and hadn't received prior chemotherapy.
In the second group, patients had acute myeloid leukemia and had relapsed after a first complete remission of less than 12 months.
The company said 150 patients were enrolled as of March 14, with 125 patients reported evaluable for toxicity and response at more than 45 days after first treatment.
The company noted non-hematologic serious adverse events attributable to Cloretazine were uncommon with grade 1 and 2 toxicities including nausea, diarrhea, fatigue, fever, pain, and dyspnea. The death rate from all causes in the first 30 days was 18%.
For patients in the first group, the treatment achieved an overall response rate of 30%. In the second group, patients had an overall response rate of 7%.
The company noted Cloretazine has been evaluated in four Phase I trials to date, two for use to treat leukemia and two for the treatment of solid tumors.
Shares of Vion were trading at $3.20 in premarket activity, according to Inet, after closing on Friday at $3, down 2 cents, or 0.7%.
Company Web site: vionpharm.com |
