|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, 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 (pless than 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.
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, 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.
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
Feb. 10, 2016 02:54 PM EST
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 10, 2016 02:30 PM EST Reads: 413
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 10, 2016 02:30 PM EST Reads: 389
Recognizing the need to identify and validate information security professionals’ competency in securing cloud services, the two leading membership organizations focused on cloud and information security, the Cloud Security Alliance (CSA) and (ISC)^2, joined together to develop an international cloud security credential that reflects the most current and comprehensive best practices for securing and optimizing cloud computing environments.
Feb. 10, 2016 01:45 PM EST
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
Feb. 10, 2016 01:15 PM EST
Sensors and effectors of IoT are solving problems in new ways, but small businesses have been slow to join the quantified world. They’ll need information from IoT using applications as varied as the businesses themselves. In his session at @ThingsExpo, Roger Meike, Distinguished Engineer, Director of Technology Innovation at Intuit, showed how IoT manufacturers can use open standards, public APIs and custom apps to enable the Quantified Small Business. He used a Raspberry Pi to connect sensors...
Feb. 10, 2016 01:00 PM EST
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
Feb. 10, 2016 12:45 PM EST
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 10, 2016 12:15 PM EST Reads: 422
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 10, 2016 12:00 PM EST Reads: 616
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 10, 2016 11:00 AM EST Reads: 182
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 10, 2016 11:00 AM EST Reads: 255
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 10, 2016 11:00 AM EST Reads: 206
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present 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. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 10, 2016 10:45 AM EST Reads: 390
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 10, 2016 10:45 AM EST Reads: 102
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Feb. 10, 2016 10:45 AM EST Reads: 245