Proteon Therapeutics (NASDAQ: PRTO) shares are up 35% this morning on news that vonapanitase has received Breakthrough Therapy designation from the FDA. The investigational treatment received the designation for increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for hemodialysis in patients on or expected to initiate hemodialysis. Secondary patency and fistula use for hemodialysis are also the co-primary endpoints of the company’s ongoing pivotal phase 3 clinical trial, PATENCY-2. Enrollment in the trial is anticipated to be complete in the first quarter of 2018, and the company expects top-line data in the first quarter of 2019. “Our productive ongoing dialogue with the FDA has helped to create a clear path forward for vonapanitase, and we look forward to continuing to work closely with the FDA to expedite our development efforts for this important program,” president and CEO Timothy Noyes stated in the news release. The company separately announced its first-quarter results for the three months ended March 31, 2017.
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About Proteon Therapeutics
Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon’s lead product candidate, vonapanitase, is an investigational drug intended to improve hemodialysis vascular access outcomes. Proteon is currently enrolling patients in PATENCY-2, a phase 3 clinical trial evaluating vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Proteon is also evaluating vonapanitase in a phase 1 clinical trial of vonapanitase in patients with PAD. For more information, please visit www.proteontx.com.
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