| November
21, 2003 Data
supporting advancement of Medarex’s (NASDAQ: MEDX) MDX-060
to phase II investigation will be presented at the American
Society of Hematology (ASH) meeting next month in San Diego.
Phase II study subject accrual is ongoing for this fully human
anti-CD30 monoclonal antibody. Ansell, et al describe initial
experiences with open-label, dose-escalation administration of
MDX-060 in patients with relapsed or refractory Hodgkin
lymphoma (HD), anaplastic large cell lymphoma (ALCL), or other
CD30+ lymphomas. The goal of the program is to establish the
safety and pharmacokinetic profiles of the drug as well as to
determine preliminary evidence of relevant biological
activity. The phase I portion of the program is fully
enrolled, with intravenous MDX-060 recipients receiving dose
levels of 0.1, 1, 5, or 10 mg/kg weekly for 4 weeks. Cohorts
of 3 to 6 patients generated data. The phase II program is
expected to use MDX-060 10 or 15 mg/kg in expanded cohorts.
21
patients (HD=16, ALCL=3, other=2) have been treated thus far.
The agent’s sub-maximal dose tolerability, infusion-related
reaction, pharmacokinetic, opportunistic infection, and other
adverse effects profiles have been reassuring. Efficacy
assessment has yet to be completed in all patients, but one
ALCL patient (in the 1 mg/kg cohort) has experienced a
complete response to therapy of 4 months duration.
CD30
is over-expressed on disease-associated Reed-Sternberg cells
in HD as well as on ALCL cells and cells of a variety of other
lymphoproliferative disorders. |
|
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