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The proven biotechnology strategy of finding a new assessment criterion to follow after the failure of a clinical trial has not worked for Proteon Therapeutics. The group's lead project, vonapanitase, missed a second phase III trial, leaving society in a chasm that will be hard to break. The final disappointment was in the Patency-2 study, which failed to show that vonapanitase improved access sites for hemodialysis in patients with chronic kidney disease; More specifically, the trial failed between its two main objectives: the use of arteriovenous fistula and secondary patency, the time that elapsed between the creation of the fistula and its abandonment. Proton shifted to these parameters after the Patency-1 trial achieved these secondary endpoints, but did not reach the primary endpoint of unassisted primary patency. . Proteon shares plunged 86% yesterday at the announcement of Patency-2's failure, valuing the group at $ 9.5 million, well short of its cash balance at the end of fiscal year 2018, which was $ 22 million. Proteon has ongoing phase I trials for vonapanitase in the treatment of peripheral arterial disease, but the future of the group seems uncertain. Maybe Proteon could provide a shell to another society in which to reverse
The last fight of Protéon? Permeability Data-2 | |||
---|---|---|---|
Period | Vonapanitase | Placebo | p-value |
Use of fistula for hemodialysis | 69.7% | 65.1% | 0.328 |
Permeability secondary to one year | 78% | 76% | 0.932 |
Source: Protein Therapeutics |
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