|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.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
May. 24, 2016 01:30 PM EDT Reads: 1,713
In his session at 18th Cloud Expo, Bruce Swann, Senior Product Marketing Manager at Adobe, will discuss how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects). Bruce Swann has more than 15 years of experience working with digital marketing disciplines like web analytics, social med...
May. 24, 2016 01:30 PM EDT Reads: 933
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
May. 24, 2016 01:15 PM EDT Reads: 624
The essence of data analysis involves setting up data pipelines that consist of several operations that are chained together – starting from data collection, data quality checks, data integration, data analysis and data visualization (including the setting up of interaction paths in that visualization). In our opinion, the challenges stem from the technology diversity at each stage of the data pipeline as well as the lack of process around the analysis.
May. 24, 2016 01:00 PM EDT Reads: 814
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
May. 24, 2016 01:00 PM EDT Reads: 834
Many banks and financial institutions are experimenting with containers in development environments, but when will they move into production? Containers are seen as the key to achieving the ultimate in information technology flexibility and agility. Containers work on both public and private clouds, and make it easy to build and deploy applications. The challenge for regulated industries is the cost and complexity of container security compliance. VM security compliance is already challenging, ...
May. 24, 2016 12:45 PM EDT Reads: 807
@DevOpsSummit taking place June 7-9, 2016 at Javits Center, New York City, and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world.
May. 24, 2016 12:00 PM EDT Reads: 3,229
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, will explore the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences betwee...
May. 24, 2016 11:00 AM EDT Reads: 1,421
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 24, 2016 10:30 AM EDT Reads: 671
SYS-CON Events announced today that 24Notion has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. 24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to con...
May. 24, 2016 09:30 AM EDT Reads: 1,666
The demand for organizations to expand their infrastructure to multiple IT environments like the cloud, on-premise, mobile, bring your own device (BYOD) and the Internet of Things (IoT) continues to grow. As this hybrid infrastructure increases, the challenge to monitor the security of these systems increases in volume and complexity. In his session at 18th Cloud Expo, Stephen Coty, Chief Security Evangelist at Alert Logic, will show how properly configured and managed security architecture can...
May. 24, 2016 09:00 AM EDT Reads: 1,947
In his session at 18th Cloud Expo, Andrew Cole, Director of Solutions Engineering at Peak 10, will discuss how the newest technology advances are reducing the cost and complexity of traditional business continuity and disaster recovery solutions. Attendees will: Learn why having a full disaster recovery strategy is more important now than ever before Explore the key drivers of a successful disaster recovery solution Achieve measurable operational and business value from a disaster recovery ...
May. 24, 2016 09:00 AM EDT Reads: 1,202
SYS-CON Events announced today the Docker Meets Kubernetes – Intro into the Kubernetes World, being held June 9, 2016, in conjunction with 18th Cloud Expo | @ThingsExpo, at the Javits Center in New York, NY. Register for 'Docker Meets Kubernetes Workshop' Here! This workshop led by Sebastian Scheele, co-founder of Loodse, introduces participants to Kubernetes (container orchestration). Through a combination of instructor-led presentations, demonstrations, and hands-on labs, participants learn ...
May. 24, 2016 09:00 AM EDT Reads: 1,780
The initial debate is over: Any enterprise with a serious commitment to IT is migrating to the cloud. But things are not so simple. There is a complex mix of on-premises, colocated, and public-cloud deployments. In this power panel at 18th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists will look at the present state of cloud from the C-level view, and how great companies and rock star executives can use cloud computing to meet their most ambitious and disruptive business ...
May. 24, 2016 09:00 AM EDT Reads: 1,969
When it comes to IoT in the enterprise, namely the commercial building and hospitality markets, a benefit not getting the attention it deserves is energy efficiency, and IoT's direct impact on a cleaner, greener environment when installed in smart buildings. Until now clean technology was offered piecemeal and led with point solutions that require significant systems integration to orchestrate and deploy. There didn't exist a 'top down' approach that can manage and monitor the way a Smart Buildi...
May. 24, 2016 08:30 AM EDT Reads: 2,030