* He has every reason to run

September 30

He has every reason to run

By Glenn Jordan gjordan@mainetoday.com
Staff Writer

Don Wright received his cancer diagnosis the same month as his first marathon medal.

click image to enlarge

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Don Wright

At the time, Wright was 62. Patients with myeloma, a blood cancer that affects cells in the bone marrow, could expect an average of another five years of life.

For Wright, that was eight years and 54 more marathons ago.

He plans to go after No. 56 Sunday morning at the Maine Marathon and Half Marathon, which starts and finishes near Back Cove in Portland.

“I’ve been given extra years of life,” Wright said Thursday while on his way east from his home in Minnesota. “I feel like I need to do the best I can with them, to make it an active and enjoyable life.”

Wright, 70, will be one of approximately 3,500 runners heading north on Route 1 Sunday morning in the 20th edition of the event. About 2,300 will turn around on Route 88 in Falmouth and head back to Portland to complete a half marathon. About 1,200 will continue through Cumberland Foreside to Yarmouth before looping back to Back Cove.

The main beneficiary from this year’s event is Camp To Belong Maine, an organization that brings together siblings separated by foster care or other out-of-home care.

A host of other charities use the Maine Marathon to raise money, most notably the Leukemia and Lymphoma Society’s Team in Training Program.

Since 1997, participants in the Maine Marathon, Half Marathon and Relay have raised more than $2.6 million.

Wright is running for Team Continuum, a nonprofit dedicated to helping cancer patients and their families with immediate, vital, nonmedical financial assistance. His campaign is called E-Race Cancer and for every “like” on his campaign’s Facebook page, sponsors will donate $5 to Team Continuum.

A mostly retired computer consultant and lawyer whose treatment consists of a daily pill that doesn’t cure his myeloma but helps keep it in remission, Wright tries to eat only organic food.

His wife Ardis and daughter Sarah will accompany him to Maine. Both plan to run the half marathon.

Wright hadn’t run regularly since high school before taking it up again after turning 60.

“I just wanted to lose weight and be healthy and strong,” he said. “Then when I got into it, I found that I really enjoyed it.”

He built up to marathon distance with the goal of qualifying for Boston. It didn’t happen that first marathon, but he qualified later the same year and ran the 2004 Boston Marathon.

His best time was 3 hours, 36 minutes at the 2006 Twin Cities Marathon when he was 65. As the marathons piled up, he started thinking about joining the 50 states club. That, and a conversation at a hematology conference last winter, led to the fundraising campaign.

Two weeks ago at a marathon in Erie, Pa., Wright checked off his 37th state. Maine will be 38. His upcoming schedule includes Hartford, Conn. (Oct. 15), Washington, D.C. (Oct. 30) and the New York City Marathon (Nov. 6).

“I feel like I’m a very lucky beneficiary of recent research and development in cancer medications,” he said. “We certainly are spending a lot of time enjoying the life that we have. As you can tell, it’s a very active life.

Staff Writer Glenn Jordan can be contacted at 791-6425 or at:

gjordan@pressherald.com

Twitter: GlennJordanPPH

Patient, doctors encouraged by ALS trial

By Miriam Falco, CNN

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updated 11:10 AM EST, Wed September 28, 2011

http://www.cnn.com/2011/09/28/health/early-als-trial-results-encouraging/index.html?hpt=he_c2

(CNN) — A little more than two years ago, Ted Harada felt his left leg weakening, and he found himself quickly running out of breath. Doctors first thought he had asthma, but in May 2010 they told him he probably had ALS, or Lou Gehrig’s disease.

In August 2010, doctors confirmed Harada, then 38, had the fatal disease, and he knew it was progressing.

“Every month they [doctors] could see deterioration,” Harada said.

ALS patients lose muscle function in the lungs until they can no longer breathe. Most people with ALS die from respiratory failure within three to five years of first symptoms, according to the National Institute of Health. The disease causes nerves to wither and the lungs to stop working. About 10% of ALS patients live 10 years or longer.

Harada joined a clinical trial at Emory University in Atlanta, where doctors were injecting neural stem cells — the precursors to nerve cells — into the lower spinal cord of ALS patients.

Before the procedure, Harada walked with a cane and would get winded just by walking to the mailbox. He had to quit his job as a manager for a shredding company. He was so tired he couldn’t play with his three children. He was too weak to pick up his youngest child. He couldn’t even open a Ziploc bag.

Harada hoped the treatment would help, but he didn’t expect it to. However, two weeks after getting the stem cell injections in March, he says he started to feel better.

“It’s been nothing short of miraculous,” he says. “I cannot begin to explain the difference it has made.”

He hasn’t touched his cane in months, he says, and his breathing has improved.

“I was afraid I would wake up and the improvements would be gone,” Harada said.

Dr. Jonathan Glass, who is overseeing the clinical trial at Emory, and Dr. Nicholas Boulis, who invented the surgical procedure used to inject the stem cells, explained to patients that participation in the trial would not cure or even benefit them personally, but it would help doctors learn more about how to treat ALS in the future.

The first phase of any clinical trial is to prove that a treatment won’t injure patients, not that the treatment works, said Dr. Eva Feldman, who designed the clinical trial at Emory.

The first part of the ALS study, sponsored by the Maryland-based biotech company Neuralstem, is designed to show that the surgical procedure to inject the stem cells into the spine is safe, and that the patients’ bodies won’t reject them. According to researchers, the cells did not harm any of the 12 patients in the Emory study, nor did they accelerate the progression of their ALS.

“I need to temper my excitement because it’s a very small patient population,” said Feldman, president of the American Neurological Association. But the facts are not discouraging. She presented early data from the study Monday at the neurological group’s annual meeting in San Diego.

“We have cautious optimism that a few of the patients may have slowed in their progression of lower extremity weakness, and one patient may have improved,” her report said.

Of the 12 patients in the trial, two have died.

John Cornick’s disease had progressed further than Harada’s by the time he received the stem cell injections in 2010. He was already in a wheelchair, and he knew participating in the clinical trial wouldn’t cure him. But he told CNN in April 2010 that the only way doctors were going to figure out how to cure ALS was to have people willing to participate in clinical trials.

“For me it just seemed like the right thing to do,” he said.

Cornick died of ALS in May. Another patient in the study, a 39-year old man, died of a heart attack.

Feldman said the conditions of eight of the remaining 10 patients have not changed. Based on these results, she and her team in Georgia are asking the Food and Drug Administration to allow them to move to the next part of the trial: Injecting stem cells higher on the spine – into the cervical spinal cord, which is in the neck.

Harada is optimistic that research like this will give other patients hope and lead to treatments in the future. He realizes he hasn’t been cured, but it’s like his clock has been set back, he says. He feels like he did when symptoms first started to appear in 2009.

“I know I still have ALS. I am so grateful for this gift regardless of how long or short it lasts,” he said.

“I can go through most days without thinking I have ALS.”

* Turning Point: Cancer diagnosis hasn’t slowed down dedicated marathoner from Lake Elmo

St. Paul Pioneer Press

9/16/2011

Turning Point: Cancer diagnosis hasn’t slowed down dedicated marathoner from Lake Elmo

http://www.twincities.com/ci_18903940?IADID=Search-www.twincities.com-www.twincities.com

By Rhoda Fukushima

Don Wright (Debra Gendel)

Don Wright of Lake Elmo ran his first marathon, Grandma’s Marathon, in June 2003. That month, he also was diagnosed with multiple myeloma, cancer of the plasma cells in bone marrow. Since then, Wright, now 70, has run 54 marathons in 36 states. He wants to do a marathon in every state. Today, Wright plans to run the Erie Marathon in Pennsylvania.

“I wasn’t expecting cancer at all. My family doesn’t have much cancer. When I got the diagnosis, I was scared. But I felt good. It was easy to be in denial, and I was, at first.

“After the initial shock, my reaction was to see if I could qualify for and run the Boston Marathon in 2004. I ran eight 20-mile runs between Grandma’s Marathon (in June) and Twin Cities Marathon (in October). I had qualifying times for Boston twice – at the Twin Cities Marathon and at the Tucson Marathon in December 2003.

“The doctor was totally supportive of my running. He believed it would strengthen my bones. I believe that, too.

“At that point and even yet, the myeloma hasn’t caused any symptoms. It was caught at an early stage. It was two more years before we started treatment.

“I started taking Thalomid. It didn’t do anything but give me a rash. I tried the supplement curcumin, but it didn’t do any good.

“In March 2008, my doctor put me on an experimental drug called pomalidomide. I have been stable ever since. I take that pill every night before I go to bed.
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“When I ran my first marathon, I was thinking, ‘Why on earth would anyone do this?’ It’s a lot of hard work and pain. When I got across the finish line, I knew I would be doing another one.

“Running is emotional, spiritual. Something just draws me to that long run. When I’m running, my mind is free to roam. I can just sort of float across the ground. I love that feeling.

“A friend of my dad’s once told me, ‘I was always ready for a marathon.’ I liked that sentiment. Now, I am always in marathon-ready shape.

“We do this as a family. My wife and daughter run either the marathon or half-marathon. That’s part of the joy.

“I train on the Gateway Trail, and we recently discovered the Lake Elmo Park Reserve. We enjoy running on the trails. This is the time of year to run in the park.

“I like to run when it’s cool. In summer, that means morning runs. In winter, we often go to the Stillwater Dome and run on the indoor soccer track. I’ve run a 20-miler in there. It’s not the most enjoyable thing, but it gets the job done.

“We are very careful about what we eat. We avoid gluten because there is some indication gluten can affect some myeloma patients in a negative way. We also buy organic food.

“I deal with injuries all the time. Name a runner’s injury, and I’ve had it. Sometimes, we have to take time off. Right now, I’m fighting a little injury, a pulled muscle in my abdomen. I’ve been going to the health club to run on the elliptical machines.

“We get to races at least one day early. We try to drive the race course and get a feel for the community. We’ve learned a lot of geography.

“My myeloma is stable. When I was diagnosed, the median survival time was eight years. Now, the median survival time has increased greatly because of new drugs.

“I feel great. Life is good.”

GT answers FDA questions for LuViva PMA application

GT answers FDA questions for LuViva PMA application

http://www.medicaldevicedaily.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=76690

By AMANDA PEDERSEN

September 6, 2011

Medical Device Daily Senior Staff Writer

Guided Therapeutics (Norcross, Georgia), a developer of a rapid and painless testing platform that uses biophotonics for the early detection of disease, says it has answered all of FDA’s key questions regarding the company’s premarket approval (PMA) application for the LuViva Advanced Cervical Scan.

“We are pleased to provide the FDA with the additional information the agency requested and within the time period required to maintain the PMA application under active review,” said Mark Faupel, PhD, president/CEO of Guided Therapeutics. “The FDA will review our submission, we hope move forward with the PMA process and schedule a panel meeting date, although the agency has the option to ask for additional information.”

LuViva scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively, the company noted. Guided Therapeutics’ biophotonic technology is designed to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, LuViva does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly and painful unnecessary testing, the company said.

Faupel told Medical Device Daily that the sequence of events with FDA so far has followed a “normal” track. “There are a number of people at FDA involved in formulating questions both with regard to the clinical side of the clinical trial and technical side of the instrumentation,” he said. There were several questions the company had previously dealt with by submitting draft responses and the majority of those were accepted on what Faupel referred to as a “first round.” There was one question, however, that the agency asked for additional information on which Guided Therapeutics says has now been dealt with. He declined to say what that issue was for competitive reasons. Now the company just has to wait and see if and when a panel meeting is scheduled.

“It was a necessary and major step in getting us closer to that panel meeting,” Faupel said.

The company submitted its PMA application about a year ago (Medical Device Daily, Sept. 28, 2010). In its pivotal trial, more than 1,600 women at risk for cervical disease were tested with the device. According to the company, the device detected cervical disease up to two years sooner than a Pap test, HPV test, colposcopy or biopsy and it detected 86.3% of cervical disease cases that had been missed by these other methods. Also, the device would have reduced the number of unnecessary biopsies by about 40%.
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The fact that the questioning phase of the process was so involved simply reflects that the company has a “fairly high visibility product with a lot of reviewers” involved, Faupel said. “They are more involved in the questions . . . leadership at FDA is very conscious now of the issues that have occurred in the past.”

While it waits for a panel meeting to be scheduled, Guided Therapeutics continues to make progress with its planned international launch and have orders in place with distributors for demonstration and clinical units for Europe and Asia, Faupel said.

“This is a product that we feel strongly will have a home not just in the U.S.,” Faupel told MDD. “It was designed to be low cost, easy to use, easy to train the user, [and] easy to interpret the results.”

Such features are what sets the technology apart from existing testing methods, he said.

“The current standard of care involves a lot of human interaction and data,” he said. He added that an initial PAP test, which requires a highly trained technician to interpret and that another test involving a magnified view of the cervix requires a well-trained physician to interpret and is subjective. “They all involve a lab delay to get a final answer, where as with our product you get a final answer at the point of care.”

The company was recently awarded $517,000 to fund the third year of a $2.5 million three-year grant from the National Cancer Institute (NCI). The grant provides additional resources to help commercialize and bring the LuViva to market. The company has been awarded more than $6 million in six consecutive grants from the NCI to develop the new test for detecting cervical disease since 2001 (MDD, Aug. 26, 2011).

In a multi-center clinical trial, with women at risk for cervical disease, the technology was able to detect cervical cancer up to two years earlier than conventional modalities, according to published reports.

The company has also entered into a partnership with Konica Minolta Opto (Tokyo) to develop a non-invasive test for Barrett’s esophagus using the technology platform.

“This is a platform technology and we believe it can be utilized to detect nearly 90% of all cancers in the body,” Faupel said.

In fact, the company has already begun human testing of its light-based technology for Barrett’s Esophagus, a precursor for esophageal cancer. The feasibility study is designed to test the concept of using the platform for the detection of changes in esophageal tissue. The study also tests various hardware and procedural configurations and is designed to determine a way forward for product development and further clinical trials. The feasibility study is expected to enroll about 40 subjects and be completed before the end of the year. It is being conducted at two Atlanta-area clinics (MDD, Aug. 11, 2011).