NEWARK, Calif., May 21, 2014 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (Nasdaq:RVNC), announced that the company's proprietary, botulinum toxin (BoNTA) investigational products will be the lead topics discussed in the Emerging Technologies panel at the 11th International Symposium of Facial Plastic Surgery in New York.
Presentation: The Next Generation in BoNTA: A Longer Lasting Injectable and Topically Applied Product - A New Portfolio to Meet Patient Needs
Date: May 27, 2014
Time: 10:00 am EDT
Location: Marriott Marquis Hotel, 1525 Broadway, New York City
The data will be presented by Jonathan Sykes, MD, FACS, Professor and Director of Facial Plastic and Reconstructive Surgery at UC Davis in Sacramento, California. Dr. Sykes is also serving as the Chair of the Symposium and has no financial relationship with Revance Therapeutics.
Dr. Sykes will present the recently released clinical data on the RT002 injectable study in frown lines which showed a median duration of 7.3 months. He will also review Phase 2b data on Revance's RT001 topical gel. Both products are in clinical development and incorporate Revance's patented TransMTS® technology.
"RT001 and RT002 have the potential to expand our treatment options," said Dr. Sykes. "For example, a recent study of injectable RT002 in the frown lines showed patients enjoying treatment benefits for more than seven months. These results are really encouraging since most patients and physicians would appreciate a longer lasting product," said Dr. Sykes.
"New products should provide meaningful benefits for patients, and this distinctive family of botulinum toxin offerings has the potential to do just that. Clinical trials are still ongoing but the benefits shown in these studies are very encouraging."
Additional highlights of the data being presented include:
RT002, Injectable Botulinum Toxin Type A for the treatment of Glabellar (frown) lines in a Phase 1/2 study:
94% of subjects were rated with None or Mild wrinkle severity at maximum frown 4 weeks post-treatment using the Glabellar Line Severity Scale as assessed by the clinical investigator. 83% of subjects assessed themselves as achieving None or Mild wrinkles at maximum frown at the same time point.
In the final cohort, the only one where duration of effect was measured, RT002 achieved a median duration of 29.4 weeks or 7.3 months based on both investigator and subject assessments.
80% of the subjects in the final cohort maintained clinically meaningful response after six months and 70% still maintained wrinkle ratings of None or Mild wrinkle severity at that time point.
RT002 was well tolerated, and there was no evidence of spread beyond the treatment site at any dose. Adverse events were generally mild, localized and transient. The most common adverse events observed were headache and injection site reactions. There were no serious adverse events or evidence of any systemic exposure.
RT001, Botulinum Toxin Type A Topical Gel for the treatment of Crow's Feet lines in two Phase 2b Studies:
Up to 89% of patients achieved a clinically meaningful improvement in their crow's feet lines
Median duration of effect was 113 days
RT001 was shown to be generally well tolerated and the majority of adverse events were mild or moderate and transient
About Revance Therapeutics, Inc.
Revance is a specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic applications. The Company is leveraging its patented TransMTS® peptide delivery system combined with the proprietary portfolio of botulinum toxin compounds to address unmet needs in the large and growing aesthetic and therapeutic dermatology market. TransMTS is a broad technology platform which enables both the delivery of large macromolecules across skin when used in a topical formulation and more targeted delivery of proteins when injected.
About RT001 and RT002
The Company has two primary product candidates. RT001, our lead product, is a topically applied formulation of botulinum toxin type A. RT001 has the potential to be the first commercially-available non-injectable dose form and is being evaluated in a broad clinical program that includes aesthetic indications such as crow's feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating) and migraine headache. Revance's second product candidate, RT002, is a novel, injectable formulation of botulinum toxin type A designed to be more targeted and longer lasting than currently available botulinum toxin injectable products.
About International Symposium of Facial Plastic Surgery
Every four years, the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) and the International Federation of Facial Plastic Surgery Societies (IFFPSS) host an international symposium that brings together facial plastic surgeons from all over the world and in the specialties of facial plastic surgery, oculoplastic surgery, dermatologic surgery, plastic and cosmetic surgery. This year's 11th symposium celebrates the 50th anniversary of the AAFPRS and features the latest trends and technologies in facial plastic surgery by offering lectures, panels, workshops and instruction courses led by experts in the field and an exhibition of over 100 companies displaying and introducing their latest products and services. The American Academy of Facial Plastic and Reconstructive Surgery is the world's largest specialty association for facial
plastic surgery. It represents more than 2,700 facial plastic and reconstructive surgeons throughout the world. The AAFPRS is a National Medical Specialty Society of the American Medical Association (AMA). AAFPRS members are board certified surgeons whose focus is surgery of the face, head, and neck.
Forward Looking Statements
This press release contains forward-looking statements, including statements related to the process and timing of anticipated future clinical development of Revance Therapeutics' product candidates, including continued plans to study RT001 and RT002 in additional clinical trials; statements about its business strategy and goals; and potential benefits of its product candidates and technologies and related impact on treatment options. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from Revance's expectations. These risks and uncertainties include, but are not limited to: the outcome, cost and timing of its product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an
effective design; Revance's ability to obtain and maintain regulatory approval of its product candidates; its ability to obtain funding for its operations; its plans to research, develop and commercialize its product candidates; its ability to achieve market acceptance of its product candidates; unanticipated costs or delays in research, development and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for its product candidates; its ability to successfully commercialize its product candidates and the timing of commercialization activities; the rate and degree of market acceptance of its product candidates; its ability to develop sales and marketing capabilities; the accuracy of its estimates regarding expenses, future revenues, capital requirements and needs for financing; its ability to continue
obtaining and maintaining intellectual property protection for its product candidates; and other risks detailed in the "Risk Factors" and elsewhere in Revance's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on May 14, 2014. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
"Revance Therapeutics" and TransMTS® are registered trademarks of Revance Therapeutics, Inc.
CONTACT: Westwicke PartnersAna Petrovic
Source: Revance Therapeutics, Inc.
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