IBPL, Kwizda complete phase I clinical trials of Neukine
Ahmedabad, Apr 9 (UNI) Intas Biopharmaceuticals Limited (IBPL) and European pharmaceutical major Kwizda Pharma GmbH have jointly completed Phase I clinical trial study of Neukine, biosimilar form of recombinant GCSF.
As per results of study, Neukine is safe and exhibits an identical pharmacokinetic and pharmacodynamic profile compared to a reference product, an IBPL press release said here today.
Neukine promotes growth of white blood cells, which help fight infections after cancer chemotherapy treatment, it claimed.
Upon completion of an upcoming clinical Phase III trial, both companies, IBPL and Kwizda, will lodge an application to get the product approved for European market. The market launch is planned for early 2010.
Announcing
the
Phase
I
results
of
clinical
trials,
Kwizda
Pharma
VP
(Research
&Business
Development)
Helmut
Brunar
said,
''Neukine
exhibits
identical
efficacy
to
the
EU-approved
reference
product.
Not
only
was
Neukine
cleared
from
the
patients' blood
plasma
just
as
quickly
as
the
reference,
but
the
number
of
neutrophils
also
increased
with
identical
kinetics
after
treatment.''
UNI
MP
MAZ
SM
SG
RK1601