stare, ale może być o tyle interesujące, że tekście pojawiają się dosyć konkretne 'milestones'
źródło:
www.infinata.com/biopharma-sol...Date 26/09/2013
Mabion has recruited 120/730 patients in the Phase III trial of its biosimilar to MabThera - executive
Mabion (WSE:MAB) recruited 120 out of 730 patients in its Phase III trial evaluating its biosimilar of Roche's (VTX:ROG) MabThera (rituximab), said Tadeusz Pietrucha, co-founder and CEO of Poland-based Biotech Consulting. The study is testing MabionCD20 in rheumatoid arthritis (RA), he noted.
The trial started enrollment in June, Pietrucha said. It is a randomized, double-blind study comparing MabThera to MabionCD20, added Magdalena Matusiak, Mabion's clinical trial coordinator.
The company also plans to start another Phase III trial with the same design to assess MabionCD20 versus MabThera (marketed in the US as Rituxan) in lymphoma, she said. That trial will have 270 patients, she added.
The trials' primary objectives will be efficacy and pharmacokinetics and secondary outcomes will include safety and immunogenicity. The RA trial has 73 clinical sites in nine countries, Matusiak said. Poland, Lithuania, Serbia and Bosnia having started recruitment, she noted; Romania, Russia, Croatia, Ukraine and Georgia have yet to start.
Mabion's intention is to file an EMA application in June or July 2014 for both indications, Matusiak said. It has not yet planned for an FDA submission but "hope to as soon as possible in 2014," she added.
Mabion's pipeline includes: MabionHER2, a biosimilar to Roche's (VTX:ROG) Herceptin (trastuzumab) for breast and gastric cancers; MabionVEGF, a biosimilar to Roche's Avastin (bevacizumab) for colorectal, lung and renal cancers; and MabionEGFR, a biosimilar to Bristol-Myers Squibb (NYSE:BMY)/Eli Lilly's (NYSE:LLY) Erbitux (cetuximab) for head, neck and colorectal cancers.
There is also an anti-TNF alpha B monoclonal antibody in development as part of a collaborative agreement, Matusiak said, as well as a biosimilar to Roche's Lucentis (ranibizumab) for several eye conditions.
by Jennifer C. Smith-Parker in Warsaw, Poland