|By Marketwired .||
|June 16, 2014 06:00 AM EDT||
TORONTO, ONTARIO -- (Marketwired) -- 06/16/14 -- Trimel Pharmaceuticals Corporation (TSX:TRL) reported results from further analysis of its Phase II clinical trial evaluating the efficacy and safety of Tefina(TM), a "use-as-required" testosterone nasal gel for the treatment of Female Orgasmic Disorder (FOD).
Tefina(TM) 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(TM) 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(TM) 0.6 mg showed a measurable improvement in distress over placebo (1.3 for Tefina(TM) 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 (pless than 0.001). -- The mean score for sexual event satisfaction (SES) improved from 1.09 for placebo to 1.38 for Tefina(TM) 0.6 mg (p=0.3). A 25% increase in the total number of sexual events for Tefina(TM) 0.6 mg relative to placebo was also observed. -- Global Sexual Function (GSF) showed measurable improvement for Tefina(TM) 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(TM) 0.6 mg.
At study completion, 45% of patients responded "yes" when asked if Tefina(TM) 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(TM) 0.6 mg, the change in orgasm was a meaningful benefit, 47% responded "yes" (p=0.3).
Tefina(TM) was found to be well-tolerated with no reported serious adverse events.
"These additional observations provide further positive support for Tefina(TM) 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(TM) 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(TM) 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.
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.
Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. Natesto(TM), 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.
SYS-CON Events announced today that MathFreeOn will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. MathFreeOn is Software as a Service (SaaS) used in Engineering and Math education. Write scripts and solve math problems online. MathFreeOn provides online courses for beginners or amateurs who have difficulties in writing scripts. In accordance with various mathematical topics, there are more tha...
Oct. 26, 2016 01:30 PM EDT Reads: 1,102
SYS-CON Events announced today that Niagara Networks will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
Oct. 26, 2016 01:15 PM EDT Reads: 1,380
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 26, 2016 01:00 PM EDT Reads: 4,997
Virgil consists of an open-source encryption library, which implements Cryptographic Message Syntax (CMS) and Elliptic Curve Integrated Encryption Scheme (ECIES) (including RSA schema), a Key Management API, and a cloud-based Key Management Service (Virgil Keys). The Virgil Keys Service consists of a public key service and a private key escrow service.
Oct. 26, 2016 12:45 PM EDT Reads: 1,158
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, will discuss how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team a...
Oct. 26, 2016 12:45 PM EDT Reads: 562
OnProcess Technology has announced it will be a featured speaker at @ThingsExpo, taking place November 1 - 3, 2016, in Santa Clara, California. Dan Gettens, OnProcess’ Chief Analytics Officer, will discuss how Internet of Things (IoT) data can be leveraged to predict product failures, improve uptime and slash costly inventory stock. @ThingsExpo is an annual gathering of IoT and cloud developers, practitioners and thought-leaders who exchange ideas and insights on topics ranging from Big Data in...
Oct. 26, 2016 12:45 PM EDT Reads: 380
@ThingsExpo has been named the Top 5 Most Influential Internet of Things Brand by Onalytica in the ‘The Internet of Things Landscape 2015: Top 100 Individuals and Brands.' Onalytica analyzed Twitter conversations around the #IoT debate to uncover the most influential brands and individuals driving the conversation. Onalytica captured data from 56,224 users. The PageRank based methodology they use to extract influencers on a particular topic (tweets mentioning #InternetofThings or #IoT in this ...
Oct. 26, 2016 12:45 PM EDT Reads: 8,544
SYS-CON Events announced today that Cemware will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Use MATLAB functions by just visiting website mathfreeon.com. MATLAB compatible, freely usable, online platform services. As of October 2016, 80,000 users from 180 countries are enjoying our platform service.
Oct. 26, 2016 12:30 PM EDT Reads: 924
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Oct. 26, 2016 12:30 PM EDT Reads: 3,951
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and ...
Oct. 26, 2016 12:15 PM EDT Reads: 1,596
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Oct. 26, 2016 12:15 PM EDT Reads: 2,226
Digitization is driving a fundamental change in society that is transforming the way businesses work with their customers, their supply chains and their people. Digital transformation leverages DevOps best practices, such as Agile Parallel Development, Continuous Delivery and Agile Operations to capitalize on opportunities and create competitive differentiation in the application economy. However, information security has been notably absent from the DevOps movement. Speed doesn’t have to negat...
Oct. 26, 2016 12:00 PM EDT Reads: 2,888
SYS-CON Events announced today that eCube Systems, the leading provider of modern development tools and best practices for Continuous Integration on OpenVMS, will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. eCube Systems offers a family of middleware products and development tools that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Oct. 26, 2016 12:00 PM EDT Reads: 4,621
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Oct. 26, 2016 12:00 PM EDT Reads: 3,554
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Oct. 26, 2016 11:45 AM EDT Reads: 1,887