Threshold Pharmaceuticals Initiates a Clinical Trial Evaluating TH-302 in Patients With Advanced Leukemias

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BlankJune 29, 2010, 8:45 a.m. EDT

Threshold Pharmaceuticals Initiates a Clinical Trial Evaluating TH-302 in

Patients With Advanced Leukemias

REDWOOD CITY, Calif., Jun 29, 2010 (GlobeNewswire via COMTEX) -- Threshold

Pharmaceuticals, Inc. /quotes/comstock/15*!thld/quotes/nls/thld (THLD 1.09,

0.00, 0.00%) , today announced that it has initiated a Phase 1 clinical trial of

TH-302 in patients with advanced leukemias. TH-302 is a proprietary

Hypoxia-Activated Prodrug (HAP) that specifically targets tumor hypoxia.

" There is an enduring unmet need for effective new treatments for patients with

refractory hematological malignancies, " said Dr. Deborah , M.D., Associate

Professor in the Department of Leukemia at MD Cancer Center. " There is

a strong preclinical rationale to evaluate TH-302 in this patient population and

we are excited to be leading this innovative clinical trial. "

Clinical Trial Design

Approximately 40 patients with advanced leukemias or other severe hematologic

disorders affecting the marrow are planned to enroll in the clinical trial at

the MD Cancer Center. Patients with relapsed/refractory chronic

lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL), acute

myelogenous leukemia (AML), advanced phase chronic myelogenous leukemia (CML),

high risk myelodysplastic syndrome (MDS) or advanced myelofibrosis (MF) will be

eligible for the trial.

The initial dose escalation phase of the trial will enroll cohorts of up to 6

patients per dose. The starting dose will be 120mg/m2 and will be administered

as a 30 minute intravenous infusion daily for 5 days every 21 days. Sequential

cohorts will be treated with TH-302 at 40% increments in dose until the maximum

tolerated dose (MTD) is established. The primary objective of the dose

escalation component of the study is to establish the MTD and dose limiting

toxicities of TH-302 when administered daily for 5 days. The dose escalation

phase of the trial will enroll up to 30 patients. Once the MTD has been

established, up to 10 additional patients will be enrolled at the MTD in the

dose expansion component of the trial. The objective of the dose expansion is to

further assess the clinical activity of TH-302 in this population.

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