Acerus Announces Publication of Manuscript Reporting Early Data from Partner-Sponsored Natesto® Spermatogenesis Study
17 Setembro 2018 - 8:00AM
Business Wire
-- Early Data Suggests Sperm
Concentration, Motility, and Total Motile Sperm Count Remain Within
Normal Ranges in Hypogonadal Men Taking Natesto® --
Acerus Pharmaceuticals Corporation (TSX: ASP) (“Acerus” or the
“Company”) today announced the publication of a clinical trial
update in the journal European Urology Focus on the effects of
Natesto® on reproductive hormones and semen parameters. This study
is being conducted at the University of Miami's Department of
Urology, and Dr. Ranjith Ramasamy, MD, the Director of Reproductive
Urology, is the study's principal investigator. The Company’s
partner, Aytu BioScience Inc. (NASDAQ:AYTU), a specialty
pharmaceutical company focused on global commercialization of novel
products addressing significant medical needs, is sponsoring this
investigator-initiated trial.
The publication, titled “Natesto Effects on Reproductive
Hormones and Semen Parameters: Results from an Ongoing
Single-center, Investigator-initiated Phase IV Clinical Trial”,
provides updated data on five of the 23 currently enrolled
subjects, through six months of Natesto® treatment. Testosterone
therapy (TTh), as a whole, is known to decrease gonadotropin
levels, diminish sperm production and function, and decrease the
natural production of endogenous testosterone in men being treated
with TTh. Maintenance of fertility and family planning is an
important consideration before initiating TTh; therefore, the
effects of Natesto® may provide physicians with a unique approach
for treating men with hypogonadism.
After both three months and six months of Natesto® therapy,
there were no statistically significant changes in sperm
concentration, sperm motility, and total motile sperm count from
baseline in the five patients being reported on. Median total
motile sperm count (TMSC) were slightly, but not significantly,
reduced from 37.5 million at baseline to 32.5 million after six
months of Natesto® therapy. Additionally, four out of five men had
total testosterone levels above 300 ng/dL, median 654.0 (389.5 -
810.3) ng/dL. Gonadotropin levels for luteinizing hormone (LH) and
follicle-stimulating hormone (FSH) were reduced, but remained
within the normal reference range.
“About two million men in the US with low testosterone are young
and interested in maintaining their fertility,” said Dr. Ranjith
Ramasamy, the study’s principal investigator. “The current options
to increase testosterone and simultaneously maintain sperm
production are not FDA-approved and therefore need to be used
off-label. The initial results from the trial with Natesto® are
exciting, and we are optimistic that the final results will be
similar to the preliminary data. Increasing testosterone levels
while maintaining fertility with Natesto®, if borne out by the
final results, could be a paradigm-shift in treatment of men with
low testosterone.”
“Should these early results bear out through the balance of the
study, they could suggest a potentially unique role for Natesto® as
a treatment option for men who wish to preserve their fertility and
gonadotropin function while being treated for hypogonadism,” said
Ed Gudaitis, President and CEO of Acerus Pharmaceuticals. “We
continue to work collaboratively with our partner to understand
fully all the benefits that Natesto® can offer patients, including
those that could help differentiate our product in the marketplace.
We appreciate Dr. Ramasamy’s leadership in conducting this study
and expect to report additional results as they become
available.”
To read the published article, please visit
https://www.eu-focus.europeanurology.com/article/S2405-4569(18)30228-1/fulltext.
Aytu BioScience is sponsoring this investigator-initiated trial,
and complete details on this study can be found at
https://clinicaltrials.gov/ct2/show/NCT03203681?term=Natesto&rank=4.
About Natesto® (Testosterone) Nasal
Gel
Natesto® is a nasal gel formulation of testosterone
developed by Acerus Pharmaceutical Corporation and
indicated as a replacement therapy for men diagnosed with
conditions associated with a deficiency or absence of endogenous
testosterone (hypogonadism). It is the first and only
nasally-administered testosterone product approved by the
U.S. FDA, Health Canada and South
Korea and available in a ‘no-touch’ dispenser with a metered
dose pump. A copy of the NATESTO® Canadian product monograph
can be found
at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO®/default.aspx.
For further information, specific to the U.S. product dosing and
administration, please visit: www.NATESTO®.com.
About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based
specialty pharmaceutical company focused on the development,
manufacture, marketing and distribution of innovative, branded
products that improve patient experience, with a primary focus in
the field of men’s and women’s health. The Company commercializes
its products via its own salesforce in Canada, and through a
global network of licensed distributors in the U.S. and other
territories.
Acerus’ shares trade on TSX under the symbol ASP. For more
information, visit www.aceruspharma.com and follow us on Twitter
and LinkedIn.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or
historical factual information may constitute forward looking
information within the meaning of securities laws. Implicit in this
information are assumptions regarding our future operational
results. These assumptions, although considered reasonable by the
company at the time of preparation, may prove to be incorrect.
Readers are cautioned that actual performance of the company is
subject to a number of risks and uncertainties and could differ
materially from what is currently expected as set out above,
including with respect to the final results of the Natesto®
spermatogenesis study and the possible effects of Natesto® on sperm
concentration, motility, and total motile sperm count remain. For
more exhaustive information on these risks and uncertainties you
should refer to our annual information form dated March 20, 2018
which is available at www.sedar.com. Forward-looking information
contained in this press release is based on our current estimates,
expectations and projections, which we believe are reasonable as of
the current date. You should not place undue importance on
forward-looking information and should not rely upon this
information as of any other date. While we may elect to, we are
under no obligation and do not undertake to update this information
at any particular time, whether as a result of new information,
future events or otherwise, except as required by applicable
securities law.
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Tricia SymmesChief Operating OfficerAcerus Pharmaceuticals
Corporationtsymmes@ceruspharma.com(416) 509-2116
Acerus Pharmaceuticals (TSX:ASP)
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