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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.
Earlier 'Reader Response'
Wolfowitz got in trouble for allegedly arranging a high-ranking position at the bank for his girlfriend, and ensuring that she got a large pay raise. Wolfowitz, a conservative long supported by US President George Bush, had taken over his top post on an anti-corruption platform, so the appointment was viewed as hypocritical and violating bank regulations." The fact is that Wolfowitz arranged the position for his girlfriend, following the guidelines approved and communicated to him by the directors of the bank. Wolfowitz only resigned after the bank recognized this fact and cleared him of any wrongdoing. After all, when a top down corrupt institution accuses their top dog of wrongdoing, whether he did or not, is irrelevant. His reputation is destroyed. That's politics, folks. Richard A Brown
Miami, Florida
***** I find it excruciatingly and embarrassingly ironic that my country would criticize another nation's intelligence and anti-terrorism efforts.
Lions' Johnson to have a bigger role
He scored a fifth TD on a 32-yard end-around run. Johnson led the Lions with a 15.8-yard average per catch. Brown turned down a recent job offer to become the offensive coordinator at the University of Tennessee, where he served as assistant head coach and wide receivers coach from 1993-94. He joined the Lions in 2006. "I like it here. I think we've got a chance. We've got a chance to be very special," Brown said. "That's exciting to me." .
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