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Clinical Trial

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NEWS
July 18, 2016 | By Kerry McKean Kelly, For The Inquirer
I am sitting here with tears in my eyes and anger in my heart. I just learned that the cancer clinical trial that my husband enrolled in - gambled on, you could say - didn't work. The data show that the pancreatic cancer patients such as my husband who received an experimental combination of two immunotherapy drugs actually died a few months earlier, on average, than those who received the standard chemotherapy treatment. The results were so disappointing that the trial has been halted.
BUSINESS
October 6, 2015 | By David Sell, Inquirer Staff Writer
Spark Therapeutics, a Philadelphia company at the forefront of gene-therapy research, reported Monday that patients in its most important clinical trial had some eyesight restored after treatment by Spark's product. For now, the name of the product is SPK-RPE65, which - along with Spark itself - was spun out of decades of research led by Kathy High at the Children's Hospital of Philadelphia, the largest shareholder in the publicly traded company. "We saw substantial restoration of vision in patients who were progressing toward complete blindness," Albert M. Maguire, principal investigator in the trial and an ophthalmologist at Penn's Perelman School of Medicine, said in a statement.
LIVING
May 24, 1999 | By Huntly Collins, INQUIRER STAFF WRITER
For two days after he was born, Brandon Joseph Ross was constantly feeding at his mother's breasts. But try as he would, he couldn't make his lips form a seal around her nipples, and little of her protein-rich milk ever reached his belly. With his weight rapidly dropping, his parents were concerned. On the morning of May 14, Susan and David Ross decided to try a radical new way to feed their son - at least from an American perspective. Sitting in a chair next to her bed in the maternity ward at Pennsylvania Hospital, Susan Ross swaddled her new baby in a cotton cloth and gently lifted a small stainless-steel cup to his lips.
NEWS
February 12, 2004 | By Walter F. Naedele INQUIRER STAFF WRITER
Colleen Jacoby last spoke to Traci Johnson on Friday, the night before Johnson is reported to have committed suicide. "On the phone, she was laughing, she was happy," Jacoby said of her call from Northeast Philadelphia to her best friend in Indianapolis. At 9 p.m. Saturday, a doctor at Indiana University Hospital pronounced Johnson dead, a suicide, according to an incident report from the Indianapolis Police Department. Johnson, 19, a 2002 graduate of Bensalem High School, had been found hanging by a scarf from a bathroom shower rod in the Lilly Laboratory for Clinical Research.
BUSINESS
July 21, 2005 | By Linda Loyd INQUIRER STAFF WRITER
Shares of Neose Technologies Inc. tumbled nearly 20 percent yesterday after the company said the Food and Drug Administration had placed a hold on a key clinical trial of its experimental anemia drug. The Horsham-based biopharmaceutical company recently filed an investigational new-drug application for NE-180, a potential treatment for anemia caused by chemotherapy. Neose announced late Tuesday, after the stock market had closed, that the FDA has placed the proposed Phase 1 clinical trial on hold.
BUSINESS
November 3, 2010 | By Mike Armstrong, Inquirer Columnist
   All eyes may be on General Motors Co.'s efforts to drive 365 million shares into the hands of the public at a guesstimated $26 to $29 per share in an initial public offering.    But a much smaller pending IPO for a Philadelphia-area life-sciences firm caught my attention.    If Cutanea Life Sciences Inc. succeeds in selling 2.3 million shares for between $6 and $7 per share, it would be the third IPO for a Philadelphia-area health-care company in 2010.    Based in Malvern, Cutanea is a virtual company that in-licenses compounds from other companies.
BUSINESS
July 12, 2006 | By Linda Loyd INQUIRER STAFF WRITER
Shares of Neose Technologies Inc. sank yesterday after the company said U.S. regulators have additional questions about development of its key drug and continued to place a hold on an early-stage clinical trial. The Food and Drug Administration has raised new questions about the stability testing of its experimental anemia treatment, NE-180, further delaying the start of a human study that has been held up since last July. The Horsham company said the FDA raised questions about the reliability of the potency test used to measure the stability of the product, a potential treatment for anemia, a deficiency in red blood cells, caused by chemotherapy.
NEWS
September 23, 2013 | By Bonnie L. Cook, Inquirer Staff Writer
  Evelyn Boss Cogan, 65, a professor at La Salle University, died Saturday, Sept. 14, of lung cancer at her home in Center City. Known to friends as Evie, she fought an eight-year battle with cancer and chronicled the experience in a 2013 article for Philadelphia Lawyer magazine. It started in 2005 with a bad cough, she wrote. After cancer was found in her right lung, a doctor told her to go home and get her affairs in order; she had six months to live. Undaunted, she sought out Corey Langer, a doctor at Fox Chase Cancer Center, who scheduled chemotherapy, radiation, and more chemo.
NEWS
August 26, 2008
Your articles "Merck faces more criticism" (Inquirer, Aug. 19) and "Journal vs. the bad seed" (Aug. 20) drew the wrong conclusion. The Advantage study was published by the Annals of Internal Medicine in 2003 after passing the journal's editorial and peer-review process that determined the study to be important new information for physicians. Dr. Harold Sox recently wrote in Annals that the way to identify a good clinical trial is to look at the importance of the scientific question it tries to answer.
NEWS
January 5, 2002 | By Stacey Burling INQUIRER STAFF WRITER
Sixty days after he received an artificial heart at Hahnemann University Hospital, James Quinn was doing well enough that the staff is planning his transfer to a private nursing facility nearby, the hospital announced yesterday. When Quinn was chosen to be part of a limited trial of the new, completely implantable device, doctors estimated that he had a 70 percent chance of dying of heart failure within a month. Designers of the clinical trial defined a successful outcome as 60 days of survival with improved quality of life, the hospital said.
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ARTICLES BY DATE
NEWS
July 18, 2016 | By Kerry McKean Kelly, For The Inquirer
I am sitting here with tears in my eyes and anger in my heart. I just learned that the cancer clinical trial that my husband enrolled in - gambled on, you could say - didn't work. The data show that the pancreatic cancer patients such as my husband who received an experimental combination of two immunotherapy drugs actually died a few months earlier, on average, than those who received the standard chemotherapy treatment. The results were so disappointing that the trial has been halted.
NEWS
July 15, 2016
ISSUE | MEDICINE It's fine for cancer centers to run ads about their successes The story about cancer centers' ads painted the picture in broad strokes ("Report: Many cancer center ads are selling hype as hope," Tuesday). As a Fox Chase patient who very likely has the same "rare gastrointestinal tumor" as the man in Sunday's ad, I am familiar with the drug he was likely given 15 years ago during a clinical trial. There are only three drugs for the gastrointestinal stomal tumor (GIST)
BUSINESS
June 22, 2016 | By Linda Loyd, Staff Writer
The first testing in people of an experimental vaccine to combat the Zika virus will begin in the next several weeks, a Philadelphia-area biotech company announced Monday. Inovio Pharmaceuticals in Plymouth Meeting and partner GeneOne Life Science in South Korea said the U.S. Food and Drug Administration has given approval to begin early-stage tests in 40 healthy adults. Shares of Inovio rose 6.97 percent, or 73 cents, to $11.20 after the announcement. The tests will be done at three U.S. locations, including Philadelphia, and will evaluate safety, tolerability, and immunogenicity of the vaccine against the mosquito-borne virus.
BUSINESS
October 12, 2015 | By David Sell, Inquirer Staff Writer
Philadelphia's gene therapy community last week marked another milestone in its resurgence when locally based Spark Therapeutics said its most advanced product helped restore some vision in patients suffering from a rare eye condition during a clinical trial. The company plans to apply for FDA approval next year. Philadelphia was in some minds the gene therapy hub in the late 1990s, until an 18-year-old man died during a clinical trial by University of Pennsylvania researcher James M. Wilson.
BUSINESS
October 6, 2015 | By David Sell, Inquirer Staff Writer
Spark Therapeutics, a Philadelphia company at the forefront of gene-therapy research, reported Monday that patients in its most important clinical trial had some eyesight restored after treatment by Spark's product. For now, the name of the product is SPK-RPE65, which - along with Spark itself - was spun out of decades of research led by Kathy High at the Children's Hospital of Philadelphia, the largest shareholder in the publicly traded company. "We saw substantial restoration of vision in patients who were progressing toward complete blindness," Albert M. Maguire, principal investigator in the trial and an ophthalmologist at Penn's Perelman School of Medicine, said in a statement.
NEWS
May 31, 2015 | By Michaelle Bond, Inquirer Staff Writer
Greg Crawford's right wrist is covered with a half-dozen multicolored plastic bracelets. "Race for Adam," reads one, for a teen in Bethlehem, Pa. "Dillon's Army," reads another, in honor of a Maryland boy. "Fight for Jessica," reads a third, for a girl in Los Angeles. "I told them I'd never take them off until we have a cure," Crawford, 50, said. The children's families gave Crawford the bracelets in 2011, the second year he biked across the country to raise money for Niemann-Pick Type C Disease, a nervous system disorder that typically strikes children.
NEWS
November 9, 2014 | By Laura Weiss, Inquirer Staff Writer
Women, racial minorities, and people over 75 are underrepresented in the clinical trials that help determine the way all cardiac patients are treated, a study from Lankenau Medical Center researchers has found. This means that the recommendations that doctors use to treat heart problems may not be the best for all groups, said senior author Peter Kowey, head of Cardiology for Main Line Health. A team at Lankenau Heart Institute and Lankenau Institute for Medical Research laid out the disparities in a research letter published online by the Journal of the American Medical Association.
NEWS
October 8, 2014 | By Marie McCullough, Inquirer Staff Writer
More than a decade after prostate cancer became the economic driver behind proton beam therapy in the U.S., it still isn't clear that men treated with the technology do better than those who get less costly radiation treatments. That's why expert groups have recently advised against insurance coverage of proton therapy for prostate cancer - and why some private plans are refusing to pay for it. The Catch-22 is that this pullback is hampering a clinical trial co-led by the University of Pennsylvania that would finally settle the question of superiority.
NEWS
September 15, 2014 | By Paul Jablow, For The Inquirer
For the eight years since her diagnosis in 2006, drugs, surgery, and chemotherapy had kept Debra Hinkle's breast cancer at bay. But now, the conventional treatments were failing, and the disease was spreading. So when her oncologist decided it was time for the Bucks County woman to consider relatively untested therapies, she was more than willing. "I thought that if I didn't do a clinical trial now, maybe I wouldn't be able to later," said Hinkle, 54, who lives in Newtown Township and works as a software-development project manager.
BUSINESS
June 19, 2014 | By David Sell, Inquirer Staff Writer
Taxes, takeovers, and preschoolers are the topics of the moment with drugmaker Shire P.L.C., whose closing stock price reached an all-time high Monday. With official headquarters in low-tax Ireland and operations in Wayne, Exton, and Lexington, Mass., Shire is the subject of takeover speculation. That's largely due to a recent trend of health-care companies trying to buy smaller outfits registered in Ireland and other countries to avoid higher U.S. corporate taxes, a move known as a tax inversion.
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