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By Scott Dance and The Baltimore Sun | October 9, 2014
Forty health care workers in Mali are receiving a vaccine that could guard against the Ebola virus as a University of Maryland School of Medicine center launches the first human trials of the experimental vaccine. One person received the vaccine Wednesday, two more were expected to receive it Thursday and dozens more are scheduled to follow in the coming weeks. The inoculation was developed at the National Institute of Allergy and Infectious Diseases in Bethesda using an inert virus that is coated in an Ebola protein, so the body builds immunity to the deadly virus.
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NEWS
By Scott Dance and The Baltimore Sun | October 9, 2014
Forty health care workers in Mali are receiving a vaccine that could guard against the Ebola virus as a University of Maryland School of Medicine center launches the first human trials of the experimental vaccine. One person received the vaccine Wednesday, two more were expected to receive it Thursday and dozens more are scheduled to follow in the coming weeks. The inoculation was developed at the National Institute of Allergy and Infectious Diseases in Bethesda using an inert virus that is coated in an Ebola protein, so the body builds immunity to the deadly virus.
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BUSINESS
By Mark Guidera and Mark Guidera,STAFF WRITER | July 12, 1996
Cel-Sci, a Maryland and Virginia-based biotechnology company, says it hopes to launch large-scale human trials within two years on an AIDS vaccine it is developing as a result of promising early test results that were announced yesterday at the 11th Annual Conference on AIDS in Vancouver, British Columbia.At the conference, Dr. James Kahn, a University of California professor of medicine who oversaw a study of the vaccine, told scientists that 78 percent of laboratory mice given white blood cells from people vaccinated with Cel-Sci's drug showed protective immune responses against the human immunodeficiency virus that causes AIDS.
HEALTH
By Melissa Healy | August 28, 2014
The National Institutes of Health has announced the first clinical trial of a vaccine to protect healthy people from infection by the Ebola virus, which is responsible for an estimated 1,550 deaths throughout West Africa. NIH Director Francis Collins on Thursday called the human safety trials, which are to start next week in Bethesda, the latest in a series of the "extraordinary measures to accelerate the pace of vaccine clinical trials" for the public health emergency in Africa.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | June 1, 1999
Guilford Pharmaceuticals Inc., the Baltimore-based biotechnology outfit, expects a whirlwind of activity in the second half of the year. The company is seeking to move two new experimental treatments -- one for ovarian cancer and one for chronic pain and peripheral neuropathy -- into clinical trials late this year or early next year. And biotechnology giant Amgen Inc. of Thousand Oaks, Calif., is expected to begin human trials of Guilford's experimental compound, known as NIL-A, in Europe this summer, said Stacey Jurchison, a Guilford spokeswoman.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | November 13, 1998
EntreMed Inc. said yesterday that plans to get one of its experimental anti-cancer drugs into human trials next year remain on track despite a published report that cancer experts have been unable to verify test results showing it shrinks tumors in mice.Shares in the Rockville-based biotechnology company plunged $7.75 -- more than 23 percent -- to $24.875 as investors reacted to a front-page Wall Street Journal article. More than 2.8 million shares traded hands, about 50 times the average trading volume.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | May 18, 1999
EntreMed Inc. said yesterday that it expects to begin human trials of its anti-cancer drug Endostatin this fall, launching a process that will answer at last whether the experimental treatment is a breakthrough drug for the illness.EntreMed and the National Cancer Institute, which is assisting EntreMed with the study and development of Endostatin, plan to test the compound on a broad range of cancer patients, as is normally done with promising new cancer treatments. The NCI said it plans to test the drug on patients with advanced solid tumors, including patients diagnosed with cancers of the breast, prostate and colon, as well as lung lymphomas.
NEWS
May 8, 1998
The Miami Herald said in an editorial yesterday: DARE we hope for a cure for cancer? Yes, a thousand times yes -- in the name of all who have died, suffered or comforted those stricken.It is hardly surprising that doctors and hospitals around the country have been flooded with calls from people wanting to take part in the human trials of two promising new anti-cancer drugs. Cancer, which now trails only heart disease as the leading cause of death in this country, saps not only its victims' strength but also that of their families.
BUSINESS
By Rona Kobell and Rona Kobell,SUN STAFF | June 24, 2000
Shares in Human Genome Sciences Inc. rose 9.3 percent yesterday after the company announced that it is ready to start human clinical trials of a drug to treat immune system disorders. The Rockville-based company made the announcement at 4:15 a.m. yesterday, prompting heavy trading in the early morning hours that drove the share price to as high as $150. It closed at $145.375, up $12.375. The company said the announcement was made at such an unusual hour to make newspapers' Internet editions.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | January 19, 2000
Shares in Human Genome Sciences Inc., which have rocketed more than 500 percent in the past 12 months, jumped even higher yesterday in expectation of an announcement today that the company will expand human trials of an experimental drug to control a painful side effect of chemotherapy. Shares in Human Genome gained $9.50, or 5.2 percent, to $194.125 on the Nasdaq. The stock traded as low as $28.75 in February. The drug, Repifermin, is being tested to see if it can control mucositis. The condition is marked by painful sores in the mouth and throat that often follow chemotherapy, which kills the mucosal cells.
NEWS
August 30, 2010
As the physician who organized the conference on animal research and alternatives, I want to emphasize that scientists increasingly turn to non-animal methods for research and testing ("Alternatives to animal testing gaining ground," Aug. 27). It is widely accepted in the scientific community that physiological differences between humans and animals manifest as profound differences in disease physiology and treatment effectiveness. Clinical, epidemiological, and pathological investigations remain the foundation of research on human disease.
BUSINESS
By M. William Salganik and M. William Salganik,Sun reporter | December 28, 2007
After years of heated debate and painstaking research, 2008 is shaping up to be a critical year in the development of stem cell therapies. And in the forefront is Columbia's Osiris Therapeutics, which has three final-phase human trials under way that it hopes will lead to approval of stem cell drugs. "All the main technologies will be in humans in the next year," after years of laboratory and animal research, said I. Richard Garr, president and CEO of Rockville-based Neuralstem Inc., which this month announced its first clinical trial for a drug developed from neural stem cells.
NEWS
By New York Times News Service | September 28, 2007
WASHINGTON -- The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found. In a report due to be released today, the Department of Health and Human Services' inspector general, Daniel R. Levinson, said federal health officials do not know how many clinical trials are being conducted, audit less than 1 percent of the nation's testing sites and, on the rare occasions when inspectors do appear, generally show up long after the tests are completed.
NEWS
By Thomas H. Maugh II and Thomas H. Maugh II,Los Angeles Times | October 20, 2006
The first studies of human gene therapy for Parkinson's disease have shown that the technique is safe and can reduce symptoms for patients, two groups of researchers have reported. Each of the 24 patients who received therapy in the two separate trials received some benefit and none had any significant side effects, researchers reported at neuroscience meetings Tuesday and last week. Gene therapy has a tarnished reputation because of problems encountered in trials against other diseases, said Katie Hood, deputy chief executive of the Michael J. Fox Foundation for Parkinson's Research.
NEWS
By JONATHAN D. ROCKOFF and JONATHAN D. ROCKOFF,SUN REPORTER | July 20, 2006
WASHINGTON -- President Bush's veto yesterday of a measure that would have expanded federal funding of research involving human embryonic stem cells promises to prolong years of sparring over whether the work promotes the destruction of life. But in many important ways, ethicists, researchers and even regulators within the Bush administration have moved past the political debate. With state and private funding, the research has moved far enough and fast enough to prompt discussions, writings and the establishment of government committees to prepare for testing the cells in human beings, which is expected in the next five years.
NEWS
By KNIGHT RIDDER/TRIBUNE | October 11, 2002
PHILADELPHIA - A new form of gene therapy offers hope of easing - perhaps reversing - the debilitating symptoms of Parkinson's disease, researchers at Thomas Jefferson University Hospital have found. The scientists demonstrated the technique in rats and have received Food and Drug Administration approval to start human trials at Cornell University this year. The trial will include 12 patients who have had severe Parkinson's disease for at least five years and don't respond to existing therapies.
NEWS
August 30, 2010
As the physician who organized the conference on animal research and alternatives, I want to emphasize that scientists increasingly turn to non-animal methods for research and testing ("Alternatives to animal testing gaining ground," Aug. 27). It is widely accepted in the scientific community that physiological differences between humans and animals manifest as profound differences in disease physiology and treatment effectiveness. Clinical, epidemiological, and pathological investigations remain the foundation of research on human disease.
BUSINESS
By Mark Guidera and Mark Guidera,SUN STAFF | March 30, 1999
Vascular Genetics Inc., a Boston-based venture which is partially owned by Human Genome Sciences of Rockville, said yesterday that it has raised an undisclosed amount of money to fund its next human trials of a pioneering gene therapy for cardiovascular disease."
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | May 21, 2002
EntreMed Inc. said yesterday that it plans to move its anti-cancer drug Angiostatin into additional clinical trials later this year after it proved safe, both when used alone and when used in combination with radiation. The Rockville company presented final results yesterday from a human test of the drug in combination with radiation at Thomas Jefferson University Hospital in Philadelphia. The results showed that Angiostatin did not increase the toxic side effects of radiation -- safety results that were the major goal of the study.
BUSINESS
By Julie Bell and Julie Bell,SUN STAFF | July 13, 2001
EntreMed Inc. said yesterday that it had begun more advanced human tests of its anti-cancer drug Endostatin, seeking to gauge its effectiveness as well as its safety. The clinical trial at M.D. Anderson Cancer Center in Houston will involve up to 30 patients who will receive Endostatin via continuous infusion, a method that pumps the drug from a small, wearable cassette into the patient. While patients with a number of different tumor types will be accepted, EntreMed President Edward R. Gubish Jr. said about half will have sarcoma or melanoma, cancers in which Endostatin showed signs of promise during earlier trials focused on safety.
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