Puma Biotechnology, Inc. 's ( PBYI ) shares lost 9.7% immediately after the company announced the top-line results from a randomized, two-arm, phase II study (NEfERTT) on its lead candidate, neratinib. Neratinib, in combination with paclitaxel, failed to show significant improvement in progression free survival (PFS) in patients suffering from first-line HER2-positive locally recurrent or metastatic breast cancer when compared to paclitaxel plus Roche's ( RHHBY ) Herceptin. The primary endpoint of the NEfERTT study was PFS. In this study, patients were randomized to receive first-line treatment with paclitaxel plus neratinib or paclitaxel plus Herceptin. Results showed that patients treated with paclitaxel plus neratinib achieved a PFS of 16.6 months while patients receiving paclitaxel plus Herceptin achieved a PFS of 16.7 months. However, the company stated that the incidence of central nervous system metastases in the patients treated with paclitaxel-neratinib combination was reduced by 52.6% than those treated with paclitaxel plus Herceptin. Detailed data from the NEfERTT study will be available in 2015. We note that Puma Biotechnology has a licensing agreement with Pfizer ( PFE ) for neratinib. Our Take We are disappointed by the top-line results from the NEfERTT study. Neratinib being the primary candidate at Puma Biotechnology, … Continue reading →

The Surrey-based developer of stem cell therapies has attracted investment from the likes of top fund manager Neil Woodford who has a 20 per cent stake, and is poised to move from Surrey into purpose-built laboratories in Wales early next year. Loading article content It said last year's loss was as expected at 4.13m after the previous year's 3.17m, while cash had eroded from 20.9m in March to 16.1m at September 30. ReNeuron conducted a groundbreaking patient trial for its stroke disability therapy at Glasgow's Southern General Hospital in 2012-13, conducted by a team from Glasgow University led by Professor Keith Muir. It reported that some patients regained movement in their limbs and showed "modest" improvements in condition, despite all having had their strokes between six months and five years earlier. Its success triggered a major investment into the group by biotechnology guru Sir Chris Evans, who joined the board in August last year. This year ReNeuron began a Phase 1 safety study at Ninewells Hospital in Dundee of its therapy for people with lower limb ischaemia, which can lead to limb amputation. The group yesterday cited "encouraging long term Phase 1 data" from the stroke study and said Phase … Continue reading →