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Maxim Phase II Clinical Trial Highlights Substantial Increase In Leukemia-FreeSurvival For Acute Myelogenous Leukemia Patients

ology, University Hospital, Uppsala. "In past randomized studies using either IL-2 alone or similar agents we have not seen evidence of significant benefit to the patients. The Maxamine results suggest the potential for a meaningful advancement in the care of AML patients."

Patients treated in their second or subsequent remission ("CR2+") historically have a poor prognosis with about 5% achieving long-term survival. The 13 CR2+ patients treated with Maxamine Therapy in the ongoing Phase II study have experienced a substantial increase in remission duration, highlighted by the following results updated as of September 1, 1998:

The median time to relapse for the CR2+ patients was 21 months, more than three times the six-month historic median.

Only 10-20% of AML patients under the current standard of care historically achieve remission inversions, the lengthening of subsequent remission times beyond the duration of their previous remissions. However, 8 of 11 (73%) of the evaluable CR2+ patients treated with Maxamine Therapy have achieved remission inversion.

Moreover, 38% of the CR2+ patients treated with Maxamine Therapy remain in leukemia-free remission.

Quality of Life during Maxamine Therapy

In the Phase II study, patients have administered more than 8,000 doses of Maxamine at home. No unexpected side effects from the drug have been identified during the study. The majority, 75%, of the evaluable patients have returned to work while taking Maxamine Therapy. The study results suggest that the administration of Maxamine Therapy at home as a remission therapy for AML is both safe and feasible.

"Quality of life is very important for AML patients during remission," said Dr. Brune. "The ability to provide remission therapy on an outpatient, at-home, basis is essential to allow the patients to maintain as closely as possible their normal lifestyle."

Maxamine Mechanism of Action

In many patients with chronic infectious
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Contact: Amy Flood
a.flood@noonanrusso.com
415-677-4455 x211
Noonan/Russo Communications
7-Dec-1998


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