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AAT-023 Clinical Trial Update
Issue 2, October 4, 2006

A word from our Sponsor...

October in Indiana has brought much anticipation this year. As with each autumn, we’ve looked forward to our trees changing color, leaves dropping and the hope of Purdue’s football team being a Big Ten powerhouse. However, this fall, the beginning of our pivotal clinical trial eclipses all of these things. While the months of July and August saw patient enrollment slowly begin as the groundwork was being laid at each of your individual sites, we are pleased to announce that enrollment doubled in the month of September as six sites have now enrolled their 1st patient. We look forward to having all of our sites participating in October and seeing patient enrollment continue to rise.

As we stated in the PI / Coordinator Teleconference earlier in September, we have set an aggressive goal to complete enrollment by the end of this calendar year and appreciate all of the hard work you are doing to make this a reality. Please let us know how we can continue to support your efforts as well as what tools and resources we could potentially develop to assist you in the process.


Meet the Medical Monitors

Linda Francisco, MD

We are pleased to introduce Dr. Linda Francisco as the Medical Monitor for the AAT-023 Trial. Dr. Francisco is Board Certified in Nephrology and Internal Medicine, and practices in the Wichita Nephrology Group (Wichita, KS) while serving as the Medical Director for DaVita’s Wichita Dialysis Center. She received her premedical education at the Universities of Nebraska and Minnesota before completing her Medical Education, Internship, Residency, and a Fellowship at the University of Iowa. Dr. Francisco also serves as an Associate Professor of Medicine at the University of Kansas School of Medicine and has authored works for a variety of publications. When asked about her hobbies, she replied, "I'll get some, when I get the time!"

Monnie Wasse, MD, MPH

We are grateful to introduce Dr. Monnie Wasse as our alternate Medical Monitor. Dr. Wasse, a native of Seattle, completed her MPH and MD degrees at the University of Washington. She is Board Certified in Nephrology and Internal Medicine, and is an Assistant Professor of Medicine at Emory University in Atlanta, Georgia, where she works as an interventional nephrologist, performing endovascular procedures at the Dialysis Access Center of Atlanta. Her research program is in the area of hemodialysis vascular access, and is supported by the National Institues of Health and Robert Wood Johnson Foundation.


ded·i·ca·ted [adj. ded´i-ka´ted]

Well, that’s how Webster’s dictionary introduces the word but we have learned that a member of our clinical trial team has taken this definition to new heights. We were amazed to hear the story of Heather Gunes-Peña, the Clinical Coordinator at Dr. Hariachar’s site in Hudson, Florida. When Heather found out that her honeymoon conflicted with her site’s NIH teleconference with WIRB, she changed her wedding and honeymoon dates so she could be on the call! Wow, now that is dedication! We are certainly not asking or expecting others to take dedication to quite this level, but do feel fortunate to have many dedicated people working on this study. Our best wishes for a lifetime of good health and happiness to Heather and her husband, Gustavo, in this very exciting time!


Committed to Growth & Development

Ash Access Technology is excited about its newly–released Clinical Coordinator Educational Incentive Program. Details of this exciting opportunity for your site to earn funds for your staff’s professional development were introduced through an email last week. Contact Rita DeVico at rdevico@averioninc.com for more info.


Enrollment (through 9/29/06)
Dr. Hariachar, Hudson, FL
11
Dr. Khwaja, Newport Beach, CA
10
Dr. Kopelman, Bakersfield, CA
7
Dr. Block, Denver, CO
4
Dr. Rogers, Ocala, FL
3
Dr. Al-Makki, Lafayette, IN
1
Dr. Fadem, Houston, TX
0
Dr. Henriquez, Bronx, NY
0
Dr. Posner, Baltimore, MD
0
Dr. Stephanz, Provo, UT
0
TOTAL
36

Medical Monitor Phone Number: (765) 413-7676
All questions regarding Inclusion/Exclusion criteria compliance, potential adverse device effects, patient safety, and other medical issues related to the study should be referred to the Medical Monitor.