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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.
SLU researchers to look at laser treatment for acne scars
ST on Monday, January 14, 2008 ST. LOUIS (AP) -- Researchers at the Saint Louis University School of Medicine plan to test a special laser treatment that might improve acne scars on people with darker skin. The scars are difficult to remove. Physicians usually treat the scars by removing the surface of the skin with powerful lasers or chemical treatments. These treatments can cause discoloration for people with darker skin. Dermatologists at Saint Louis University plan a clinical trial to see if a gentler laser treatment might help. The technique would use lasers that bypass the surface of the skin and stimulate collagen growth underneath. .
Silverton may sue doc over laser treatment
British news presenter Kate Silverton is threatening to sue the doctor who conducted the laser skin-rejuvenation procedure that temporarily disfigured her.
Silverton, 37, underwent the treatment to have acne scars removed and to improve her skin tone; however, her face ended up swollen and covered in painful sores and lumps, the Daily Telegraph reported.
She was also forced to take two weeks off from her job at the BBC, the report said.
Although Silverton is now back to work, she told her attorneys to begin proceedings against the Jan Stanek clinic in London.
"It's been awful. I went in to get some minor scarring on my cheeks treated. I was told it would be a routine procedure and I'd be back to work in days. The treatment, however, caused a massive skin reaction," Silverton told the Telegraph.
Microsoft, the sleeping giant, wakes again
Yahoo's board of directors has decided to reject the offer, a person familiar with the matter said Saturday. The person, who is close to Yahoo management, said the company planned to tell Microsoft in a letter Monday that the deal undervalues the Internet company and fails to offset its risk if regulators were to overturn the merger.
Although Yahoo doesn't want to sell to Microsoft, it has few alternatives. Many analysts expect Microsoft to sweeten its offer, and Yahoo to accept it.
If it wins Yahoo, the Redmond, Wash.-based software giant will have pulled off by far the largest acquisition in its 33-year history to try to keep Google from getting further ahead.
"Microsoft tends to be a reactive company," said Mark Anderson, an entrepreneur and author of an industry newsletter that counts Gates and Microsoft Chief Executive Steve Ballmer among its subscribers.
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