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