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4/12/2012 6:36 AM ET
(RTTNews) - AVEO Pharmaceuticals Inc. (AVEO: News) said the previously reported results from a Phase 2 trial evaluating the efficacy and safety of tivozanib in 272 patients with advanced renal cell carcinoma were published in the Journal of Clinical Oncology. Results showed improved median progression-free survival or PFS among patients treated with tivozanib compared with placebo, and that tivozanib was well tolerated with minimal off-target toxicities, the company added.

Phase 2 trial's positive results informed the design and implementation of TIVO-1, a pivotal Phase 3 study in advanced RCC demonstrating tivozanib superiority over sorafenib in the primary endpoint of PFS in the first-line setting, top-line data from which were reported in January 2012.

Based on the positive Phase 2 data and success of the TIVO-1 trial, AVEO and its collaborator Astellas Pharma Inc. are moving forward with plans for submitting the tivozanib NDA in RCC in the third quarter of 2012, with the MAA submission to follow.

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by RTT Staff Writer

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Of the elite runners competing in the 26.2-mile Boston Marathon, many aim to qualify for other races, some want beat personal records, and others want to be able to say they’ve completed the trek over Heart Break Hill.

But Doctor Martin Pollak has a very different motivation: Dr. Pollak is not racing to beat the clock, but racing to beat kidney disease.

Dr. Pollak is the Chief of the Nephrology Division at Beth Israel Deaconess Medical Center. Pollack and his research team have made great strides in the battle against kidney disease.

Two years ago, they discovered a crucial link between African-American ancestry and an increased chance of being diagnosed with kidney disease. The genetic differences discovered by Dr. Pollak indicate that African-Americans are five times more likely to be diagnosed with Kidney disease than other patients. The breakthrough was monumental, but Dr. Pollak has no intentions in slowing down.

“When I found the out the development offices were giving out four to five marathon spots for fundraising purposes, I thought the race would be an interesting challenge for myself,” Dr. Pollak recalled.

Pollak plans to use this fundraising opportunity to further his kidney disease research. His ultimate goal is to bring the rate of kidney disease in African Americans down to the same rate as it is for those of European-American descent. 

So, why the Boston Marathon? What compelled Dr. Pollak to put himself through the months of extensive training and sacrifices? Well, if one thing is for certain, Dr. Pollak seems open and excited to challenge himself especially for the good of his cause.

“This race is big enough to be a real challenge, but wasn’t too outrageous that I felt I couldn’t actually meet or complete the challenge, that’s important. Also, the past nine months of training have been great for my health--I feel great.”

Dr. Pollak seemed excited to race for the cause and believes that, after recently turning fifty and reaching a milestone, the Boston Marathon was something he needed to complete.

While he is very confident Dr. Pollak admits there are some pre-race nerves and jitters but with his friends, family, and hopefully some members of his lab team cheering him on bib number 24922 should cross the finish line with no problem.

To donate to Dr. Pollak and support his fight against kidney disease, visit http://www.crowdrise.com/nephrology. He has already raised over $6,000. 

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LAGUNA HILLS, Calif., April 12, 2012 /PRNewswire via COMTEX/ -- Vessix Vascular, Inc., a developer of novel percutaneous radiofrequency (RF) balloon catheter technology for the treatment of hypertension, announced today that veteran medical device sales and marketing executive Michael D. Gioffredi has been named Chief Commercialization Officer.

Gioffredi has worked as an executive in the medical device industry for over 25 years and for the past six years served as Senior Vice President of Sales and Marketing at Fremont, CA-based AngioScore, Inc., a developer of angioplasty scoring balloon catheters used in treating artery disease. Previously, he was Chief Marketing Officer at Irvine, CA-based Cardiac Science, Inc.

"Mr. Gioffredi brings extremely valuable expertise in global marketing and sales to Vessix that will assist us to accelerate commercialization of the Vessix V2 Renal Denervation System," said Chief Executive Officer Raymond W. Cohen. "We are currently in the midst of our international, multi-center REDUCE-HTN renal denervation clinical study for medication-resistant hypertension and believe now is the right time for us to begin preparing for commercialization in Europe. Michael has a track record of producing specific and measurable results with velocity - I know this first hand having worked together in the past to successfully launch new products worldwide."

Vessix's V2 Renal Denervation System for the treatment of hypertension is an over-the-wire balloon catheter with electrodes mounted on the exterior of the balloon to facilitate the delivery of RF to the adventitia layer of the renal artery.

Vessix at EuroPCR 2012 Vessix announced that it will be exhibiting its V2 RF balloon catheter Renal Denervation System in booth M72 at the EuroPCR 2012 conference to be held May 15-18 in Paris.

During EuroPCR, Vessix will be presenting at the Cardiovascular Innovation Pipeline on Renal Denervation to be held on Wednesday, May 16 at 3:00 pm in Room 351.

About Renal Denervation Renal denervation is a percutaneous, catheter-based therapy that uses radiofrequency energy to disrupt renal (or kidney) sympathetic nerves whose hyperactivity leads to uncontrolled high blood pressure, also called resistant hypertension.

According to the American Heart Association, a 5 mm Hg (millimeters of mercury) reduction in systolic blood pressure results in a 14 percent decrease in stroke, a 9 percent decrease in heart disease, and a 7 percent decrease in overall mortality. Renal denervation has shown in clinical studies to be safe, durable and effective in reducing systolic blood pressure by as much as 20 percent.

Numerous analysts suggest that there are more than 12 million patients worldwide whose blood pressure remains uncontrolled, despite taking three or more anti-hypertensive medications. This represents a global market opportunity for renal denervation approaching $30 billion.

About Vessix Vascular, Inc. Founded in 2003, Vessix is a privately held pre-revenue stage company developing novel radiofrequency balloon catheter technology. The Company is backed by world-class European and U.S. venture firms including NeoMed Management AS, Edmond de Rothschild Investment Partners and OrbiMed Advisors LLC. For more information on Vessix Vascular, please visit the Company's website at www.vessixvascular.com or contact Matt Clawson at Allen & Caron Inc at 949-474-4300 or via email at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

        Contact: Matt Clawson or
                 Len Hall (Media)
                 Allen & Caron Inc
                 949-474-4300
                 
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SOURCE Vessix Vascular, Inc.

Copyright (C) 2012 PR Newswire. All rights reserved

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