Monday, January 07, 2008 9:32:23 AM
Monday January 7, 9:00 am ET
-Initial 10 mcg/kg MAXY-G34 Cohort Met Key Safety Criterion of Duration of Neutropenia-
-No Serious Adverse Events or Immunogenicity to Date-
REDWOOD CITY, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Maxygen, Inc. (Nasdaq: MAXY - News) today announced positive progress in its Phase IIa trial of MAXY-G34 for the treatment of chemotherapy-induced neutropenia. Initial observations from the trial include the following:
-- Patients in the initial 10 mcg/kg MAXY-G34 cohort met the safety
criterion for duration of neutropenia (less than or equal to five days
of severe neutropenia). In these trial conditions, severe neutropenia
typically lasts approximately seven days without G-CSF support.
-- No serious adverse events or immunogenicity issues were noted for the
initial cohort of patients on 10 mcg/kg of MAXY-G34. Data available
from multiple patients after multiple doses revealed no binding
antibodies, and drug response in all patients has been sustained.
-- The Data Safety Monitoring Board overseeing the trial approved
escalation to the second dose level of 30 mcg/kg MAXY-G34. The first
cohort of patients at this level is enrolled and currently undergoing
treatment.
-- To date, no serious adverse events or drug-related grade 3 or 4 adverse
events have been reported in any patient receiving MAXY-G34. A total of
23 doses of MAXY-G34 have been delivered to patients in the 10 mcg/kg
and 30 mcg/kg cohorts.
http://biz.yahoo.com/prnews/080107/aqm068.html?.v=28
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