Vion Pharmaceuticals Announces Initiation of a Phase I/II Trial of Cloretazine(R) (VNP40101M) in Combination with Temodar(R) in Adult Br...( NEW HAVEN Conn. Sept. 17 /- VIONP...),Health

NEW HAVEN, Conn., Sept. 17 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION) today announced that an investigator-sponsored trial of its lead anti-cancer agent Cloretazine(R) (VNP40101M) in combination with Temodar(R) (temozolomide) in relapsed or progressive adult malignant gliomas had been initiated at the Robert H. Lurie Cancer Center under the direction of Dr. Jeffrey J. Raizer, Principal Investigator.

The objective of the trial is to establish the maximum tolerated dose (MTD) and safety profile of Cloretazine(R) (VNP40101M) in combination with temozolomide and then to study this dose in an expanded number of patients. Cohorts of 3-6 patients receive escalating doses of Cloretazine(R) (VNP40101M) until the MTD is determined (Phase I). In Phase II, response rates, progression-free survival and overall survival will be evaluated in addition to the safety profile. Patients receive oral temozolomide on days 1-7 and intravenous Cloretazine(R) (VNP40101M) over 15-30 minutes 2 hours after the last dose of temozolomide on day 7. Treatment repeats every 7 weeks in the absence of disease progression or unacceptable toxicity.

Correlative studies conducted as part of the trial will measure: (i) the level of O6 alkylguanine DNA alkyltransferase (AGT) expression in peripheral blood monocytes before treatment with temozolomide and just prior to the administration of Cloretazine(R) (VNP40101M); (ii) the status of O6- methylguanine-methyltransferase (MGMT) methylation as well as other methylation patterns in plasma from patients treated with this regimen relative to outcome; and (iii) Cloretazine(R) (VNP40101M) in the cerebral spinal fluid and serum/plasma in Phase II.

Dr. Raizer commented, "One
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