| NEWS
ATX-101 ClEARS THIRd pHASE II Kythera’s ATX-101 demonstrates positive results in third phase IIb study
Study finds no evidence of increased oncologic risk in fat-graft patients
investigational first-in-class injectable adipolytic drug for the reduction of submental fat. the randomized, double-blind, placebo-
K
controlled, dose-ranging study showed atX-101 was well tolerated and demonstrated statistically significant efficacy in 129 subjects across 10 research centres throughout the us. reported adverse effects were mild to moderate and transient in nature. Kythera since announced the initiation of phase iii studies with atX-101 on
ythera BiopharMaceuticals, inc (Kythera) has completed a third phase ii clinical study with atX-101, its
january 10th, in collaboration with Bayer healthcare’s dermatology unit, intendis, which has licensed rights to atX-101 outside of the us and canada. patricia Walker, Md, phd, Kythera’s chief
Medical officer has said, “We are very pleased with the results and the meaningful improvements the subjects achieved. this is truly a breakthrough for aesthetic medicine, bringing together clinician and patient reported outcomes on validated scales, along with an objective and quantifiable endpoint. We look forward to presenting the data at an upcoming scientific meeting.”
US medical societies form Physicians’ Aesthetic Coalition to promote patient safety
The increasing popularity of cosmetic procedures in the US has prompted a new alliance to educate the public in patient safety issues. The formation of the Physicians Aesthetic Coalition (PAC), on January 27th as a cooperative, multispecialty initiative will represent over 8,000 board certified practitioners from The American Society for Aesthetic Plastic Surgery (ASAPS), the American Academy of Facial Plastic & Reconstructive Surgery (AAFPRS), the American Society Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) and the American Society for Dermatologic Surgery (ASDS). “One of the Coalition’s founding principles is to develop educational forums for the public and media, transparent and free of commercial bias” said Jeffery S. Dover, MD, President of the ASDS. “Over the next several months we will be announcing new resources to help differentiate fact from fiction”.
A review published in the American Society of Aesthetic Plastic Surgery’s Aesthetic Surgery Journal shows that patients receiving autologous fat grafts to the breast exhibit no increased risks associated with breast cancer. The study entitled, ‘Oncologic Risks
of Autologous Fat Grafting to the Breast’ (Aesthet Surg J. 2011 Jan 1;31(1):68-75), critically discusses clinical outcomes from over 2,000 women, including those who have undergone previous breast cancer treatment. Authors John Fraser, Ph.D. and Marc
Hedrick, M.D. of Cytori Therapeutics (NASADQ: CYTX), and leading US plastic surgeon Steve Cohen, MD suggest that theoretical concerns surrounding the procedure do not seem to support actual clinical evidence. “There is increased patient and
physician demand for our technologies and this careful review supports our view that our recommended fat grafting techniques are safe in the breast”, said Christopher Calhoun, CEO of Cytori Therapeutics. “We will continue to conduct our own safety research and analyze data from sources external to Cytori, as part of the regulatory progress and the ultimate commercial adoption of our products.”
prime-journal.com | March 2011 ❚ 11
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80