|
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.
New Study Shows Isolaz Can Reduce Acne Up to 90 Percent
SANTA MONICA, Calif., Feb. 1 /PRNewswire-FirstCall/ -- Southern California-based dermatologist Ava Shamban, MD and co-investigators Mikiko Enokibori, MD, and Vic Narurkar, MD, conducted a global multi-center study using Isolaz to treat patients suffering from various degrees of acne, ranging from mild and moderate inflammatory acne to severe nodular and cystic acne. The February edition of the Journal of Drugs in Dermatology will report the results of this study using the Isolaz device (Aesthera Corp(TM), Pleasanton, CA) for the treatment of mild to severe acne. Prospective and retrospective data was collected from 56 patients who had undergone two to four treatments with a photopneumatic device (Isolaz). Evaluation criteria included lesion counts, using blinded physician evaluations of acne clearance, as well as treatment satisfaction surveys given to the participating physicians and patients.
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.
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.
Vlasic sails 2.03, Silnov 2.37 in Arnstad
World Champion Blanka Vlasic and Andrey Silnov won the traditional high jump meeting in Arnstadt (Germany), which saw its 32nd edition on Saturday. The Croatian was the dominant figure in the women's event, clearing all her heights at her first attempts – including the winning height of 2.03m. That was an improvement of her season's best and world lead by two centimetres. The 24-year-old tried 2.06m twice but then retired from competition. Olympic Champion Yelena Slesarenko took second place with a season's best of 2.01m while Vita Palamar (Ukraine) was third (1.99). Germany's new High Jump hope Ariane Freidrich, who had jumped two metres for the first time a week ago, had to be content with 1.96 m and fourth place. Russia's Andrey Silnov tied his personal best and improved his season's best as well as his indoor best with a jump of 2.37m.
|
