DGAP-News: Apricus Biosciences Announces Formation of Clinical Advisory Board as Part of Its Plans to Further the Clinical Development of Femprox(R)
ID: 367275
15.03.2011 15:08
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SAN DIEGO, 2011-03-15 15:08 CET (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(r), 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(r), 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(r) 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(r) 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(r)
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 thelate
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(r) 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(r), 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(r), timing and success of an eventual commercial launch of Femprox(r),
the potential size of the markets in each of these countries, the ability to
develop and commercialize the Company's Vitaros(r) 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.
CONTACT: Apricus Biosciences, Inc.
Edward Cox
Investor Relations&Corporate Development Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
News Source: NASDAQ OMX
15.03.2011 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Apricus Biosciences, Inc.
United States
Phone:
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Internet:
ISIN: US9901429525
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Datum: 15.03.2011 - 15:08 Uhr
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News-ID 367275
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