Clinical Trial

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.

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.

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.

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.

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.

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.

Cellegy Pharmaceuticals Inc. said yesterday that a Nigeria-based study of its product to prevent HIV infection has been stopped because of a lack of convincing evidence that the microbicide gel protects against HIV. The announcement was the latest bad news for the small Huntingdon Valley firm. In July, U.S. regulators informed Cellegy that its ointment Cellegesic was "approvable," but the agency wanted more evidence - another clinical trial - showing the nitroglycerin product was effective, before approving it for sale to treat pain associated with chronic anal fissures.

Cellegy Pharmaceuticals Inc. said yesterday that it was selling its technology for several products to a British-based firm for $9 million, but will continue to develop one potential product, a contraceptive. ProStrakan Group P.L.C., a publicly traded company in Galashiels, Scotland, will acquire four Cellegy drug candidates and all related intellectual property. ProStrakan is Cellegy's marketing partner for two of the products in Europe. Cellegy, a small firm based in Huntingdon Valley, intends to remain a public company, with five employees, and will move next week to smaller offices in Quakertown.

A Cephalon Inc. drug to treat attention deficit hyperactivity disorder in children is not acceptably safe and needs more study, U.S. medical experts said yesterday. A Food and Drug Administration panel of advisers said that Cephalon's data on the stimulant Sparlon, currently sold under the name Provigil for sleep disorders, showed that it was effective, but that worrisome questions about the drug's safety outweighed its benefit for ADHD. The panel's 12-1 vote against recommending approval based on safety concerns was a huge blow to the Frazer biotech.

   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.

   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.

Wayne-based Encorium Group Inc., which runs clinical trials and patient registries for pharmaceutical companies, announced today that it has acquired Swiss-based Progenitor Holdings AG, for euro 1.7 million (about $2.2 million). Progenitor has wholly owned subsidiaries in Mexico, Panama, Argentina, Chile, Switzerland, India and Hong Kong. Encorium said in a statement that the acquisition would give it access clinical trials being conducted in such emerging markets as Latin America, India and the Asia Pacific region.

Concerned that American men may be embracing the same kind of misguided sex-hormone use that brought calamity to women, the government is funding a national study to see whether older men with low testosterone benefit from boosting it. Led by University of Pennsylvania endocrinologist Peter Snyder, the $45 million clinical trial, which this month began recruiting 800 men older than 64, is by far the largest ever to compare the effects of the...

Two Chester County businessmen pleaded guilty yesterday in federal court in relation to their rolesin conducting illegal clinical trials that involved use of a bone cement during spinal surgery. Michael D. Huggins, 51, of West Chester, and John J. Walsh, 46, of Coatesville, could face probation to six months in prison when they are sentenced in October to one misdemeanor count of shipping misbranded bone cement. They were released on $100,000 unsecured bond each and ordered to surrender their passports.

THE article "Why don't More Patients Get into Clinical Trials?" (April 23) doesn't tell the whole story on why many cancer patients choose standard therapy as opposed to the state-of-the-art care offered in clinical trials. The article makes the arguments that physicians are reluctant to discuss clinical trials and that patients are sometimes fearful of side effects stemming from "experimental" treatments. These are problems that have been, and will continue to be, addressed through educational outreach.

SOON AFTER Elizabeth Buell-Fleming was diagnosed at age 2 with a rare nerve-cell cancer, her parents and doctors discussed getting her into an experimental study. Not that proven treatments were unavailable; she would receive the latest, best care. The issue was how the toddler from Newark, Del., might play a small part in the discovery of even better therapies by being in a clinical trial. "We were told about clinical trials from the beginning" in 2006, said her father, Boyd Fleming.

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.

Each year, about 30,000 Pennsylvanians die from cancer. And while the overall trend of cancer mortalities and new cancer cases has been declining, the rates in Pennsylvania - and Philadelphia in particular - remain well above the national averages. Pennsylvania's death rate from cancer through 2004 was 199.8 per 100,000 people, about 4 percent higher than the national average (192.7 per 100,000), according to the National Cancer Institute. However, the death rate in Philadelphia (244.

Cellegy Pharmaceuticals Inc. said yesterday that it was selling its technology for several products to a British-based firm for $9 million, but will continue to develop one potential product, a contraceptive. ProStrakan Group P.L.C., a publicly traded company in Galashiels, Scotland, will acquire four Cellegy drug candidates and all related intellectual property. ProStrakan is Cellegy's marketing partner for two of the products in Europe. Cellegy, a small firm based in Huntingdon Valley, intends to remain a public company, with five employees, and will move next week to smaller offices in Quakertown.

Shares of Neose Technologies Inc. fell yesterday after the Horsham company said an early stage human trial for its drug to treat a side effect of chemotherapy may be delayed. Neose said its partner, Germany-based BioGeneriX AG, has advised Neose that the start of a Phase 1 clinical trial could be delayed unless it secured a financing and development partner. Neose and BioGeneriX are developing the compound, GlycoPEG-GCSF, to treat neutropenia, a severe reduction in white blood cells caused by cancer chemotherapy.