GenVec receives orphan drug designation

Source: www.onemedplace.com Author: staff GenVec’s experimental drug to treat pancreatic cancer has been granted orphan drug status by the U.S. Food and Drug Administration (FDA). The drug candidate TNFerade stimulates the production of an immune system protein known for having anti-cancer effects. Shares in GenVec rose 25 percent following the announcement. Last summer, Gaithersburg, Maryland-based GenVec announced positive data from a Phase II/III clinical trial of TNFerade. The drug provided a 42.5% reduction in the risk of death when combined with standard treatment, when compared to standard treatment alone. TNFerade is also being explored as a candidate to treat esophageal cancer, rectal cancer, and head and neck cancer. Note: The FDA grants orphan drug designation to drugs that may be significantly more effective than currently existing treatments, and target conditions that affect less than 200,000 U.S. patients per year. Upon approval, drugs granted orphan status enjoy seven years of marketing exclusivity in the United States.

2009-11-08T12:07:30-07:00November, 2009|Oral Cancer News|

Fight Against Cancer: Patient vs. Process

Why One Cancer Patient Is Fighting a Drug Company Working on a Cure Source: abcnews.go.com Author: John Donovan On this relatively good morning in the course of her mom's inoperable cancer, Jackie Loughman, of Indianapolis, knows some facts about pain that she wishes she didn't. "She is mostly in bed and in pain all the time, and, you know, it is hard to watch," Loughman said of her mother, Connie. But the fact really throwing Jackie and Connie is that there is a drug out there that has saved at least one pancreatic cancer patient — and Connie can't get it. Richard Jordan, a Colorado landscaper, was supposed to be dead by now, but he got into a trial for the drug TNFerade. His wife called it "a miracle." Jordan's oncologist, Dr. Raj J. Shah of the University of Colorado, said, "The remarkable thing of his story is that he went on to surgery — but more importantly, when they removed the mass, no cancer was left or seen. With pancreatic cancer, the complete response is really rare." Connie is disqualified from the TNFerade trial by her participation in an earlier trial for a different drug that she says made her sick. TNFerade is made in Maryland by a small firm called GenVec, which told Jackie and ABC News in a statement: "We are working aggressively to advance our product candidate, TNFerade, through the required clinical studies and regulatory review process. ... Unfortunately, this process makes it impossible for GenVec [...]

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