QLT announces FDA filing and review of Aczone(TM) labeling supplement for removal of blood screening requirement Jul 23, 2007
The Phase IV clinical trial of Aczone was performed to meet a post-approval commitment requested by the FDA. The purpose of this study was to gather more information about the safety of Aczone, a prescription topical medicine, in treating patients with acne who have G6PD deficiency. During a six-month period, patients were treated with both Aczone and the Aczone-vehicle (control group) in a cross-over design. (PR Newswire)
QLT USA, Inc. files Aczone(TM) labeling supplement for removal of blood screening requirement May 29, 2007
"This filing represents a significant milestone in our Aczone program and in our efforts to bring the first new compound in a decade for the treatment of acne to patients in the U.S.," said Bob Butchofsky, President and Chief Executive Officer of QLT. "If the FDA approves the label revision we believe Aczone could be a key contributor to our growth strategy with a potential launch of Aczone in 2008." The Phase IV clinical trial of Aczone was performed to meet a post-approval commitment requested... (PR Newswire)
G6PD Deficiency Is Associated With Significant Protection Against Severe, Life-threatening Malaria Mar 14, 2007
G6PD deficiency is also known as "favism" after the Italian word for broad beans (fava) which cause a classic reaction when eaten by people with G6PD deficiency. In males, who have only one X chromosome, mutations in the gene for G6PD on the X chromosome cause G6PD deficiency ... G6PD deficiency is associated with protection against malaria, notably in Africa where one form of G6PD deficiency (G6PD A-) is widespread. (Science Daily)
QLT announces positive findings from Phase IV G6PD deficiency study for Aczone(TM) in acne Nov 8, 2006
Company to Pursue Discussions with FDA on Labeling VANCOUVER, Nov. 7 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) today announced positive results of a Phase IV clinical trial of Aczone(TM) in more than 50 patients with G6PD deficiency that was performed to meet a post-approval commitment requested by the FDA. The purpose of this study was to gather more information about the safety of Aczone, a prescription topical medicine, in treating patients with acne who have certain blood... (PR Newswire)
Scale, Toll of Gene Birth Defects Vast, Study Finds Jan 31, 2006
Many people there carry a gene for an inherited disease, such as sickle cell, thalassemia, or G6PD deficiency, that protects against malaria but can produce birth defects when carriers mate. The incidence of birth defects and disability can be sharply reduced in developing countries, the report concluded. (LA Times,CA -- Intl)
3.3m children worldwide die of birth defects, study says Jan 31, 2006
"The report found that five defects -- congenital heart defects, neural tube defects such as spina bifida, blood disorders such as sickle cell disease, Down syndrome, and a blood disease called G6PD deficiency -- account for 26 percent of serious genetic problems. The toll from these defects could be reduced through better prenatal care and early recognition when a fetus is likely to be born with a defect, the authors said.''Overall mortality and disability from birth defects could be reduced by... (Boston Globe)
