Cynata Therapeutics (CYP: $0.016) announced the results from two major studies last week. The first was a Phase II study in patients with GvHD. The second was a Phase II/III study in 321 patients with osteoarthritis. Both failed to meet the primary endpoint.
In the GvHD study, the Overall Response Rate (ORR) at 28 days was similar to the control (57.37% compared to 54.8% in the control). At 100 days, the ORR in the active arm fell to 23.1% compared to 32.3% in the control. This compares to the previous single arm GvHD study where the ORR was 67% at day 28, and increased to 73% at day 60.
There were some differences between these two studies. In the Phase Ib study, all patients had failed steroid therapy. In the current study, the therapy was offered to patients earlier with corticosteroids. But when patients failed to respond, they were offered ruxolitinib therapy (most before 28 days), which was not approved when the Phase Ib study was started.
The osteoarthritis study was conducted by the University of Sydney. Whilst there has been evidence of efficacy in smaller single arm studies conducted by others in this indication, Cynata had not conducted an earlier trial in this indication. On the primary measure of changes in pain threshold, (patient-acceptable symptom state), the results in the active and control arms were similar (51.7% versus 48.1%).
On the more objective measure of loss in cartilage thickness, the active arm decreased by 0.27mm compared to just 0.21mm in the control.
The results potentially highlight the challenges in commercial scale manufacture of complex therapies such as stem cells, and ensuring activity at the stage of delivery to the patient, even though potency assays were conducted. The results also indicate that the non specific action of stem cells is a challenge to confirm in a randomized controlled study environment.
The Cynata board is now assessing the options for the company. It had $3.1 million in cash on a pro forma basis including funds raised in April. The company is also expecting an R&D tax rebate of around $1.2 million.
Bioshares recommendation: Exit
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