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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.
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.
Hip-Hop Rumors: Raz B's Video, Roy Jones Fights Dogs?, Kim K Engaged ...
Shout out to Da Brat! She celebrated the New Year with Mariah in Vegas. Ahhhhh…Brat is cute. The Mariah New Year's Eve celebration was at TAO and drew stars like Randy "Dawg" Jackson, Kelis, Mario, Nas, and me. Just kidding. PHARCYDE'S ON TOUR? The Pharcyde is getting back together? I know some of you are too young too care or too old to care. I am right there in the middle and I care. With that stated, I heard that some of the members of the Pharcyde are working together and they are doing spot dates. I have to admit that I hate the fact that they had to break up, only to reunite many years ago just to get back to the good old music. Anyway, we'll see. RANDOM QUOTES Kelly Rowland on why she fell out (The Mirror, UK): “I was exhausted.
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.
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.
Hip-Hop Rumors: Raz B's Video, Roy Jones Fights Dogs?, Kim K Engaged ...
Shout out to Da Brat! She celebrated the New Year with Mariah in Vegas. Ahhhhh…Brat is cute. The Mariah New Year's Eve celebration was at TAO and drew stars like Randy "Dawg" Jackson, Kelis, Mario, Nas, and me. Just kidding. PHARCYDE'S ON TOUR? The Pharcyde is getting back together? I know some of you are too young too care or too old to care. I am right there in the middle and I care. With that stated, I heard that some of the members of the Pharcyde are working together and they are doing spot dates. I have to admit that I hate the fact that they had to break up, only to reunite many years ago just to get back to the good old music. Anyway, we'll see. RANDOM QUOTES Kelly Rowland on why she fell out (The Mirror, UK): “I was exhausted.
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