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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.
Full Text of Obituaries Published During 1999
Griffith of Fountain Hill; five sisters, Inez Lindsey of Camden, Edith Hendrix of Bastrop, LA, Irene Shattuck of Pittsburgh, KS, Frieda Prosser of Rangley, CA, and Marie Meredith of St. Paul, CA; and five grandchildren. Grave-side services were at 10 a.m. Thursday, October 28, at the Carlock Cemetery with Rev. Charles Pullin officiating. Arrangements were by Cromwell Funeral Home of Hamburg. Mr. Ira Lochala Mr. Ira Lochala, 92, of Crossett died Friday, October 29, 1999, at the Crossett Leisure Lodge. Born January 12, 1907, in Crossett to Walter and Ala Bama Rickman Lochala, he was a retired Georgia-Pacific employee and a member of the Quigley Holiness Church of Marion, LA. He was preceded in death by his wife, Nora Lochala, and a grandson, Michael A. Lochala. Survivors include a son, Raymond Lochala of Crossett; a daughter, Nettie Jean Tietz of Crossett; a brother, W.
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