WALTHAM, Mass., Sept. 1, 2015 (GLOBE NEWSWIRE) — Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced the addition of Jennifer Panagoulias as Vice President of Regulatory Affairs. In this position, Jennifer will oversee all facets of Proteon’s regulatory affairs, providing oversight for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities.
Jennifer joins Proteon from Alnylam Pharmaceuticals, where she was Senior Director of Regulatory Affairs. Prior to Alnylam, Jennifer held progressively senior positions at Genzyme Corporation, rising to Global Therapeutic Head, Regulatory Affairs Neurology after Sanofi’s acquisition of Genzyme.
“We are pleased to have Jennifer join our team. Her proven track record in U.S. and international regulatory affairs for global biotechnology franchises will be invaluable to Proteon,” said Timothy Noyes, President and Chief Executive Officer. “Jennifer will play a pivotal role in the late stage clinical development and potential regulatory filing and approval of Proteon’s lead product candidate, vonapanitase.”
Proteon is currently enrolling patients in two Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical studies of investigational vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis. Proteon recently completed a Phase 1 clinical study of vonapanitase in patients with symptomatic peripheral artery disease (PAD).
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 (formerly PRT-201), is an investigational treatment intended to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Proteon is currently evaluating vonapanitase in two Phase 3 clinical trials in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic AVF for hemodialysis and has completed a Phase 1 clinical trial in patients with symptomatic peripheral artery disease (PAD). For more information, please visit www.proteontherapeutics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, “forward-looking statements.” In some cases these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates, “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” or, in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including those regarding the potential use of vonapanitase for patients with renal and vascular diseases, the effect of vonapanitase on AVF patency, regulatory filing and approval of vonapanitase, the benefit to Proteon of Ms. Panagoulias’ experience, the significance of Ms. Panagoulias’ role at Proteon and those relating to future events or our future financial performance or condition, involve substantial known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors, including whether our cash resources will be sufficient to fund our operating expenses and capital expenditure requirements for the period anticipated; whether data from early clinical trials will be indicative of the data that will be obtained from future clinical trials; whether vonapanitase will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; and whether we can successfully commercialize and market our product candidates, are described more fully in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on August 13, 2015, and our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March 20, 2015, and our Current Reports on Form 8-K, as filed with the SEC, particularly in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” In light of the significant uncertainties in our forward-looking statements, you should not place undue reliance on these statements or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements contained in this press release represent our estimates and assumptions only as of the date of this press release and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this press release.
Investor Relations Contact
George Eldridge, Proteon Therapeutics, Senior Vice President and Chief Financial Officer
Chris Erdman or Lynnea Olivarez, MacDougall Biomedical Communications