Trimel Reports Additional Results From Tefina(TM) Phase II Clinical Trial
16 Giugno 2014 - 12:00PM
Marketwired
Trimel Reports Additional Results From Tefina(TM) Phase II Clinical
Trial
TORONTO, ONTARIO--(Marketwired - Jun 16, 2014) - Trimel
Pharmaceuticals Corporation (TSX:TRL) reported results from further
analysis of its Phase II clinical trial evaluating the efficacy and
safety of Tefina™, a "use-as-required" testosterone nasal gel for
the treatment of Female Orgasmic Disorder (FOD).
Tefina™ 0.6 mg showed a 35% increase in the average number of
orgasms versus placebo (p=0.0013) and 58% of women had at
least one orgasm, compared to 43% of women in the placebo group.
The median number of orgasms achieved was two for Tefina™ 0.6 mg
versus zero in the placebo group.
Secondary endpoints for the trial included the assessment of
changes from baseline in distress, sexual event satisfaction and
sexual functioning. Note that the trial was not powered to
demonstrate statistical significance for the secondary
endpoints.
- Tefina™ 0.6 mg showed a measurable improvement in distress over
placebo (1.3 for Tefina™ 0.6 mg, 0.9 for placebo, p=0.14).
Of note, the difference from placebo steadily increased over the
84-day treatment period. The reported change in distress from
baseline achieved statistical significance
(p<0.001).
- The mean score for sexual event satisfaction (SES) improved
from 1.09 for placebo to 1.38 for Tefina™ 0.6 mg (p=0.3).
A 25% increase in the total number of sexual events for Tefina™ 0.6
mg relative to placebo was also observed.
- Global Sexual Function (GSF) showed measurable improvement for
Tefina™ at all dose strengths and in all domains of sexual function
(e.g. arousal, desire, lubrication orgasm, satisfaction and pain).
The strongest improvements reported were observed in the orgasm
domain of GSF with Tefina™ 0.6 mg.
At study completion, 45% of patients responded "yes" when asked
if Tefina™ 0.6 mg provided a meaningful improvement in their
ability to achieve orgasm (p=0.17) . When asked if, as a
result of treatment with Tefina™ 0.6 mg, the change in orgasm was a
meaningful benefit, 47% responded "yes" (p=0.3).
Tefina™ was found to be well-tolerated with no reported serious
adverse events.
"These additional observations provide further positive support
for Tefina™ 0.6 mg as a potential treatment for the many women
suffering from female orgasmic disorder," stated Tom Rossi,
President and Chief Executive Officer of Trimel. "Once our analysis
is complete, we hope to meet with the United States Food and Drug
Administration to determine the next steps to advance the clinical
development of this exciting opportunity."
About Tefina™ AMB-2012-01 Phase 2 Clinical Study
AMB-2012-01 was a double-blind, placebo-controlled study having
enrolled 253 pre- and post-menopausal women experiencing acquired
FOD in the United States, Canada and Australia. Participants were
randomized to one of three dosage strengths (0.6 mg, 1.2 mg, 1.8
mg) or a placebo group and treated over the course of 84 days. The
primary endpoint of the study was to compare the effects of the
three dose strengths of Tefina™ nasal testosterone gel to placebo
on the occurrence of orgasm.
Secondary endpoints included measures of distress, sexual event
satisfaction and global sexual function using standardized
questionnaires administered monthly and after 84 days of treatment.
Distress was quantified using the Female Sexual Distress Scale
specific for Female Desire Arousal Orgasm (FSDS-DAO). Sexual Event
Satisfaction (SES) was measured by the MONASH Female Sexual
Satisfaction Questionnaire (MONASH FSSQ). Global Sexual Function
(GSF) was measured using the total score from the Female Sexual
Function Index.
Investor Event
Trimel held an Investor Event on Thursday, June 12, 2014 at the
Toronto Region Board of Trade. A webcast of this event will be
available at http://trimelpharmaceuticals.com/
Investors/Investor-Day.
About Female Orgasmic Disorder
Female Orgasmic Disorder, also known as anorgasmia, is
characterized by a marked reduced intensity of orgasmic sensations,
or marked delay in, marked infrequency of, or absence of, orgasm
that has persisted for a minimum duration of approximately six
months, and causes clinically significant distress in the
individual. The diagnosis is further specified by whether the
dysfunction has been lifelong or acquired. Currently, there are no
approved treatments for Female Orgasmic Disorder.
About Trimel
Trimel is a specialty pharmaceutical company actively developing
medications for male hypogonadism, female sexual dysfunction and
various respiratory disorders. Natesto™, a product utilizing
Trimel's licensed nasal gel technology, has approved for sale in
the United States by the FDA. For more information, please visit
www.trimelpharmaceuticals.com.
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. For
more exhaustive information on these risks and uncertainties you
should refer to our annual information form dated March 5, 2014
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.
Trimel Pharmaceuticals CorporationKenneth G. HowlingChief
Financial Officer416 679
0536ir@trimelpharmaceuticals.comwww.trimelpharmaceuticals.com
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