338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment
SAN MATEO, Calif., September 04, 2008 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. today announced that the pivotal clinical study of Polidocanol, conducted in Germany by BioForm Medical's partner, Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler), successfully met the study primary endpoint and has been submitted to FDA as part of a New Drug Application (NDA) process.
In the pivotal clinical study, named the EASI (Efficacy and safety of Aethoxysklerol compared to Sodium Tetradecyl Sulfate and Isotonic Saline) study, 338 patients with C1 varicose veins (either spider veins of <1mm diameter or reticular veins of 1-3mm diameter), were randomized to receive either Polidocanol (also called Lauromacrogol 400, European tradename, Aethoxysklerol(R)), Sodium-tetradecyl-sulfate (STS or Sotradecol(R), an effective control), or Isotonic saline (a placebo control). Patients were followed for 26 weeks (6 months) with standardized photography of a defined 10x10 cm area of the leg at baseline, 12 weeks and 26 weeks. These photographs were rated by the treating physicians and two blinded evaluators, which served as the basis for efficacy assessment.
The EASI study successfully met its primary efficacy endpoint with demonstrated statistically significant superiority (p<0.0001) of Polidocanol versus placebo. The treatment success rates for Polidocanol were 96% and 95% at 12 and 26 weeks, compared to STS (92%, 91%) and placebo (8%, 6%). A secondary endpoint analysis demonstrated that significantly more patients were satisfied or very satisfied with Polidocanol at 12 or 26 weeks (88%, 84%), compared to STS (63%, 64%; p<0.0001) or placebo (13%, 11%; p<0.0001). Polidocanol was found to be safe and well tolerated in the study. The incidence of side effects, most commonly local tissue reactions near the injection site, was generally lower for patients treated with Polidocanol than for patients treated with STS.
"We are very pleased that the EASI study successfully demonstrated the safety and the efficacy of Polidocanol for the treatment of spider and reticular veins," said Professor Eberhard Rabe, President of the International Union of Phlebology (UIP) and the German Society of Phlebology (DGP) and Professor at the Department of Dermatology, University of Bonn, and the principal investigator in the study. "Polidocanol has been used successfully to treat spider and reticular veins in Europe for over 40 years, and we are pleased to participate in this clinical evaluation to evaluate Polidocanol. These results scientifically confirm our every day experience in clinical practice, and the high patient satisfaction seen with Polidocanol, as compared to STS."
The EASI Study results will be presented at several scientific congresses in the coming weeks by Professor Eberhard Rabe, the principal investigator in the study. Planned presentations include September 8, 2008, at the Australasian College of Phlebology meeting in Australia, November 7, 2008, at the American College of Phlebology, and November 9, 2008, at the American Society of Dermatologic Surgery late-breaking results session.
"We are delighted with the results of this clinical study," said Steve Basta, Chief Executive Officer of BioForm Medical, Inc. "We believe that bringing Polidocanol into the U.S. market will allow physicians in the United States to use what has been regarded internationally as the gold standard product for sclerotherapy, and that the lower rate of local tissue reactions evidenced in this trial versus the leading competing product, combined with the high success rate of this treatment may be the basis of significant future growth in sclerotherapy procedure volume in the United States upon FDA approval and the subsequent commercial introduction of Polidocanol."
"For years, Polidocanol has been the worldwide standard for sclerotherapy of spider veins outside of the United States, and I am very excited about the prospect of being able to offer this treatment option to my patients in the future," said Robert Weiss, MD, President-Elect of the American Society for Dermatologic Surgery (ASDS) and Associate Professor, Dermatology at , Baltimore, Maryland. "If Polidocanol becomes available in the United States, the physician community will have an important additional tool in their aesthetic treatment portfolio."
Kreussler, the company that developed Polidocanol as a sclerotherapy agent and has commercialized this product throughout the world over the past 40 years, conducted the pivotal clinical study pursuant to a special protocol assessment agreed to with FDA in 2006. The EASI study was specifically designed to provide the pivotal clinical data for the FDA related to the open New Drug Application (NDA) for Polidocanol. The final clinical study report on the EASI study has been submitted to FDA as an amendment to the existing NDA. In addition to this clinical report, Kreussler is completing manufacturing documentation for a newly expanded manufacturing facility. Consistent with the previously reported expected timeline for completion of the NDA submission, the manufacturing documentation is expected to be completed and submitted to FDA before the end of calendar year 2008.
BioForm Medical and Kreussler entered into an agreement in 2007 wherein BioForm will have exclusive U.S. rights to sell Polidocanol supplied by Kreussler upon FDA approval, and BioForm will pay Kreussler a royalty and transfer price for the supplied material, and development and commercialization milestone payments.
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California, developing products that enhance aesthetic procedures performed in dermatology and plastic surgery practices. BioForm Medical's lead product is Radiesse(R) dermal filler, a long-lasting filler for use in facial aesthetics. BioForm Medical is developing several future aesthetics products, including a radiofrequency treatment to reduce nerve function in the forehead, a sclerotherapy treatment for spider veins, and a surgical adhesive for brow lifts. For more information about BioForm, please visit http://www.bioform.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the timing of completion of the NDA submission, receipt of FDA approval for Polidocanol's commercial sale in the United States, and the expectation of significant future growth in sclerotherapy procedure volume in the United States following FDA approval of Polidocanol, are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, which may cause BioForm Medical's actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect BioForm Medical's business and its financial results are detailed in its latest Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2008. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. BioForm Medical undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
Contact: Adam Gridley 650.286.4025 Vice President, Corporate Development BioForm Medical, Inc.
CONTACT: Adam Gridley, Vice President, Corporate Development of BioFormMedical, Inc., +1-650-286-4025
Web site: http://www.bioform.com/
Ticker Symbol: (NASDAQ-NMS:BFRM)
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Posted: September 2008