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December 9, 2012
16:40 EDTTKPYYMillennium and Takeda report data from Phase I trial of ADCETRIS
Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited announced results from two arms of a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma, MTCL, patients, including patients with systemic anaplastic large cell lymphoma, sALCL. These data were presented at the 54th American Society of Hematology, ASH, Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate, ADC, directed to CD30. ADCETRIS is not approved for use in the front-line treatment of MTCL.
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September 21, 2015
16:28 EDTTKPYYIntra-Cellular announces completion of Phase 1 studies for ITI-214
Intra-Cellular Therapies (ITCI) announced that it is assuming sponsorship of the Investigational New Drug Application for studies related to ITI-214. ITI-214 is a novel, potent phosphodiesterase type 1 inhibitor. Multiple human clinical Phase 1 studies have been completed. In these studies, ITI-214 demonstrated a favorable safety profile and was generally well-tolerated across a broad range of doses both in healthy volunteers and in patients with schizophrenia with a pharmacokinetic profile that supports once daily dosing. Under a license agreement, Takeda (TKPYY) conducted four Phase 1 studies. A single rising dose study was conducted in the US in healthy male and female, Japanese and non-Japanese volunteers. In a second US study ITI-214 was administered once daily over 14 days to healthy volunteers and patients with stable schizophrenia. In a third study, conducted in Japan, ITI-214 was administered for 7 days at multiple rising oral doses in both male and female healthy volunteers. A fourth study compared the relative bioavailability of oral formulations of ITI-214 used in all previous studies to an immediate-release tablet, either with or without food in healthy volunteers. The Company is currently evaluating ITI-214 for several indications including cognition in patients with Parkinson's disease, dementia, schizophrenia and other CNS and non-CNS disorders.

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