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Isolagen Modifies Ongoing Clinical Program For Acne Scars
FDA has provided follow-up on the Phase III program investigating Isolagen's Therapy for the treatment of moderate to severe acne scars. The FDA reiterated that there are no safety issues that would prevent the initiation of the proposed studies. However, the FDA asked the Company to further clarify certain protocol issues and raised questions related to the acne scar Evaluator Assessment Scale and Photo Guide. The FDA recommended that in order to address these issues, the Company should conduct a Phase II study; therefore, the Company will propose modifying the ongoing Phase III Study IT- A-008 as a Phase II/III study (as discussed further below). The FDA requests are specific to the acne scar clinical program and do not impact the Company's ongoing, pivotal Phase III clinical program evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles.Isolagen's two randomized, double-blind, placebo-controlled acne scar clinical trials (IT-A-008 and IT-A-009) of approximately 120 patients eachwere designed and powered as Phase III studies.
Isolagen Initiates Phase III Clinical Program to Investigate Isolagen ...
EXTON, Pa., Nov. 7 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (AMEX: ILE) announces the initiation of a Phase III clinical program to investigate Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. Isolagen also has a pivotal Phase III clinical program underway to evaluate the Isolagen Therapy in treating nasolabial folds, or wrinkles. "Millions of people in the U.S. suffer from acne which often scars, a condition that can be very distressing and difficult to treat as there are few options currently available," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Isolagen. "We are pleased to be initiating this important clinical development program which we believe will address this largely unmet medical need." Two randomized, double-blind, placebo-controlled trials will evaluate the safety and efficacy of Isolagen Therapy in patients with moderate to severe acne scarring on both sides of the face.
Acne Drug Accutane Ups Cholesterol
In a study involving almost 14,000, mostly young patients taking the drug, elevations in blood cholesterol, triglycerides (a blood fat), and a blood liver function test were more common than have been previously reported. Blood levels returned to normal or to pretreatment levels in the vast majority of patients in the months after they stopped taking Accutane, however. Researchers say this finding is reassuring, but they add that patients should be followed longer to see if there are long-term implications for cardiovascular and liver disease risk. "We do want to know if there are long-term consequences, but that was not a part of this research," researcher Michele Manos, PhD, MPH, tells WebMD. Tighter Controls on Drug First approved in 1982 for the treatment of severe disfiguring acne , Accutane use in women has long been linked to an increased risk of miscarriage and birth defects.
Assault at HRC Store
Sgt. Brett Parson, head of the Washington Metropolitan Police Department's special liaison units, including the Gay and Lesbian Liaison Unit (GLLU), and the Human Rights Campaign have confirmed a report that the HRC Corner Store and Action Center at 1633 Connecticut Ave. NW was robbed around 7 p.m. on Friday, Jan. 18. An unnamed 23-year-old male working in the store was assaulted during the robbery, which netted approximately $400. Parson says the victim was pistol-whipped, suffering cuts and bruises to head, for which he was treated and released. Parson described the suspect as a black male in his mid 20s to early 30s, about 5'4'', 135 pounds, with a light complexion, clean-shaven, with minor acne scars on his chin. At the time of the robbery, the assailant was wearing a dark-green knit hat; a long, puffy black coat; black dress pants; and a tie.
Miami U's 2007 gifts total $44.5M
Miami University received 35,670 gifts for $44.5 million in 2007, its second-highest total ever. The donations trailed the 2006 total of $51.9 million, but the number of contributions increased 5 percent, Miami said Wednesday. Miami is trying to raise $500 million in a university-wide campaign and has reached $325 million after raising $73 million last year. .
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