SAN DIEGO, March 15, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq:APRI) today announced the formation of a Male and Female Sexual Dysfunction Clinical Advisory Board ("Sexual Dysfunction Clinical Advisory Board") as a first step to further the development of its product Femprox®, for female sexual arousal disorder ("FSAD"). The Sexual Dysfunction Clinical Advisory Board consists of key opinion leaders, Irwin Goldstein, M.D., Jed Kaminetsky, M.D. and Ajay Nehra, M.D. The Sexual Dysfunction Clinical Advisory Board is the second clinical advisory board maintained by the Company. Apricus Bio also has an Oncology Clinical Advisory Board focused on its current product PrevOnco™, for advanced unrestricted hepatocellular cancer ("HCC"), or liver cancer, as well as a Scientific Advisory Board. Apricus Bio owns the worldwide rights to Femprox®, a combination of alprostadil and DDAIP. To date, the Company has completed one Phase II trial in the United States and one Phase III study in close to 400 women in China, which achieved a 44% positive response rate as compared to a placebo. Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted that, "The Company's plans include a focus on meeting with the U.S. Food & Drug Administration in order to agree on the planned Phase III clinical program required for marketing approval in the U.S. We are also planning to meet with Canadian agency officials to seek guidance as to whether the current Phase III trial will be sufficient for filing a New Drug Submission ("NDS") in Canada." To the Company's knowledge, there is currently no approved product in any major market to treat female sexual arousal disorder, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. It is estimated that there are approximately 50 million potential sufferers in the U.S. alone (Fitzheny and Sandberg 2005), and that the market value in the U.S. could exceed $4 billion, with only 15% of patients captured on therapy.
Clinical trials have shown that Femprox® exerts a relaxant effect on vulvar and clitoral blood vessels in women, leading to increased blood flow. This leads to pelvic engorgement and enhanced secretion activity of the vulvar epithelium. The resultant increase in lubrication and sensory feedback due to pelvic engorgement is believed to produce a clinically significant increase in sexual arousal in women with FSAD. Apricus Bio's Femprox® enables a rapid permeation of blood deep into the target tissues, thus potentially enabling a new pharmacotherapy for the treatment of FSAD.Dr. Damaj stated, "We are pleased that Drs. Goldstein, Kaminetsky and Nehra have agreed to serve on our new Sexual Dysfunction Clinical Advisory Board. Their expertise will be key to helping us move forward with our Femprox® program as well as in the development of other products in the male and female sexual dysfunction field." Dr. Irwin Goldstein, M.D. is a Clinical Professor of Surgery at University of California at San Diego and Director of San Diego Sexual Medicine. Dr. Goldstein has been involved with sexual dysfunction research since the late 1970's. His interests include penile microvascular bypass surgery, surgery for dyspareunia, physiologic investigation of sexual function in men and women, and diagnosis and treatment of sexual dysfunction in men and women. He has authored more than 325 publications in the field of sexual dysfunction, with 20 consecutive years of funding by the National Institutes of Health in this area. He is Editor-in Chief of The Journal of Sexual Medicine, the official journal of the International Society for Sexual Medicine, its regional affiliate societies, and the International Society for the Study of Women's Sexual Health. Dr. Goldstein graduated from McGill University Faculty of Medicine in 1975. He was on the faculty of Boston University School of Medicine for 25 years where he was Professor of Urology and Gynecology and founding Director of the former Institute for Sexual Medicine at BUSM. Dr. Goldstein is currently President of The Institute for Sexual Medicine, Inc., a charitable corporation for education and research in the field. He is Secretary of the International Society for the Study of Women's Sexual Health, a former President of the Sexual Medicine Society of North America, a board member of the International Society for Sexual Medicine and a member of the International Academy of Sex Research, the American Urological Association, the American Association of Sex Educators, Counselors and Therapists, and the International Society for the Study of Vulvovaginal Disease. Dr. Goldstein is a 2009 winner of the Gold Medal awarded by the World Association for Sexual Health in recognition of his lifetime contributions to the field.
Dr. Jed Kaminetsky, M.D. is a Clinical Associate Professor at New York University Medical Center and is a practicing urologist with University Urology Associates, one of the largest urologic practices in the New York City metropolitan area. He is a reputable urologist and is highly skilled in treating all urologic disorders and performing minimally invasive prostate surgeries. Dr. Kaminetsky's academic interests include the study of both male and female sexual dysfunction, which has led him to become a national and world thought leader. Dr. Kaminetsky's work has been published in several journals which led to a nationwide recognition and development of various treatment schemes for patients with sexual and erectile dysfunction, including the creation of Dream Cream, a topical formulation for the treatment of female sexual dysfunction. Moreover, Dr. Kaminetsky is an experienced principal investigator who participates in national research studies that explore pharmacologic and diagnostic techniques for various urologic disorders. He is currently conducting studies addressing premature ejaculation, ED, male and female sexual dysfunction, UTIs, BPH, acute pyelonephritis, chronic non-bacterial prostatitis, prostate cancer, voiding dysfunction, treatment and prevention of stone disease, and hypergonadism. His hospital appointments include New York University Medical Center, New York Downtown Medical Center, Saint Vincent's Hospital, and Saint Vincent's Catholic Medical Center. Dr. Kaminetsky has been consulting for several pharmaceutical companies including Bayer Corporation, UNIMED Pharmaceuticals, Pharmacia Corporation, Schering-Plough and Vivus, Inc.Dr. Ajay Nehra, M.D. is a Professor of Urology at the Mayo Medical School, and a consultant in the Department of Urology of the Mayo Clinic, both in Rochester, MN. He received his medical degree from the All India Institute of Medical Sciences in New Delhi, and served his residency at the Boston University School of Medicine, and a residency and chief residency at Maimonides Medical Center in Brooklyn, N.Y. Dr. Nehra has been the principal investigator with more than seven clinical multicenter investigational studies of the efficacy and safety of a number of treatments for erectile dysfunction. He is a co-investigator in the National Institutes of Health program project on aging. Dr. Nehra has contributed more than 100 articles and 120 abstracts, mainly on male sexual dysfunction, male infertility, neuro-urology, prosthetics, urologic oncology and BPH. He has also written ED-related chapters of books and he has co-authored a book of commentary on sexual dysfunction in medicine. Dr. Nehra is a former President of the Sexual Medicine Society of North America, a board member of the American Urological Association and many national and international professional societies. Dr Nehra is a thought leader and consultant for many pharmaceutical companies including, GlaxoSmithKline, Pfizer, and Sanofi-Aventis.
About Apricus Biosciences, Inc.Apricus Bio, a San Diego based revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes and cosmeceuticals among others. For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.com. You can also find out more about the Company by visiting http://twitter.com/apricusbio, http://facebook.com/apricusbio. Apricus Bio's Forward-Looking Statement Safe Harbor Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, timing for seeking U.S. and foreign approvals for Femprox®, timing and success of an eventual commercial launch of Femprox®, the potential size of the markets in each of these countries, the ability to develop and commercialize the Company's Vitaros® product for erectile dysfunction and other products and product candidates on its own and with partners and the ability to meet its milestones. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
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