StemCell Therapy

A publication in Science Translational Medicine shows that Roche has a rising star in the 15 million patient market of age-related macular degeneration (AMD). In a Phase II trail US and German researchers showed efficacy in geographic atrophy, an advanced stage of AMD, which has currently no treatment.

One week prior to the publication, Roche announced it has intitiated two Phase III trails (CHROMA and SPECTRI) enroling 936 patients with the advanced form of AMD that affects 5 million AMD patients and has currently no cure. Primary endpoint is slowing for disease progression at 12 months, secondary endpoint is visual acuity at 24 months. However, rumors say the FDA could accelerate patient access through granting breakthrough status to the treatment.

In a multi-center, randomized, 18 month Phase study that recruited 129 AMD patients ( MAHALO), lead author Brian Yaspan observed a 20% reduction in lesion area progression in patients receiving Roche/Genentechs antibody drug candidate lampalizumab at acceptable safety profile. Lampalizumab zeroes in on complement D, part of the innate immune defenses alternative complement pathway

Genome analysis of participants identified a patient subgroup with complement D variants who showed a 44% reduction in geographic atrophy area progression. The authors say targeting the alternative complement pathway has potential to be a viable treatment option for patients with secondary geographic atrophy.

More:
Roche's lampalizumab halts geographic atrophy - European Biotechnology

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