|By Marketwired .||
|December 5, 2012 08:03 PM EST||
LOS ALTOS, CA -- (Marketwire) -- 12/05/12 -- Pherin Pharmaceuticals announced today that a Phase II clinical trial showed that its proprietary compound PH94B demonstrated significant benefits in the acute treatment of symptoms of Social Anxiety Disorder (Social Phobia). Based on the positive study results, Pherin has met with the US Food & Drug Administration to plan a Phase III pivotal study of PH94B for the acute treatment of Social Anxiety Disorder. Also, Pherin has received Notification of Issuance from the US Patent & Trademark Office for its patent application covering the acute treatment of Social Anxiety Disorder with PH94B and similar allowances in the European Union, Japan, China and other major countries.
Phase II Study Results
The Phase II study was conducted in three centers to evaluate the effect of PH94B for the acute treatment of symptoms of Social Anxiety Disorder, as well as its safety and tolerability. It was a randomized, double blind, single-administration, placebo-controlled study in 91 Social Anxiety Disorder patients, using validated psychometric scales. PH94B (800 nanograms) was evaluated against placebo. PH94B significantly improved the primary efficacy endpoints (social performance and social interaction anxiety) within 10 minutes of administration. Secondary efficacy endpoints for the trial included additional anxiety response assessments and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial period. PH94B showed clinical efficacy to reduce Social Anxiety Disorder symptoms in 75.6% patients as compared with placebo (37% only). The PH94B treated group improvement exceeded the placebo treated group during a Public Speaking challenge (t = 3.16; p < .01) and also during a Social Interaction challenge (t = 2.67; p < .01).
"These results are impressive and position PH94B favorably in efficacy, safety, route of administration and dosing convenience against other existing therapeutic options which require chronic dosing and have concurrent side effects," said Dr. Louis Monti, Executive Vice President of Pherin Pharmaceuticals. "We are enthusiastic about sharing data with interested companies to co-develop PH94B. If the magnitude of benefits shown in this Phase IIB study is confirmed in a larger-scale Phase III study, intranasal PH94B could represent a major improvement in the way Social Anxiety Disorder will be treated in the future."
There were no adverse events associated with PH94B and the medication was well tolerated. Pherin attributes these results to the unique formulation of PH94B.
Pherin Pharmaceuticals also reports that it held a successful End-of-Phase II meeting with the U.S. Food and Drug Administration regarding PH94B. Pherin is in the process of submitting the safety reports of four favorable studies and an updated version of the Phase 3 clinical protocol in order to enable Pherin to move into Phase 3 clinical trials in the very near term.
Pherin also reports that the US Patent & Trademark Office has issued a Notice of Allowance for Pherin's patent application covering the acute treatment of Social Phobia with PH94B. A corresponding application in Mexico and Australia have already issued as patent; while corresponding applications in China, Japan and the European Patent Office have been allowed; and applications remain pending in several other countries. Pherin expects these applications and patents to provide broad intellectual property protection for the use of PH94B in the acute treatment of Social Anxiety Disorder.
About PH94B and Social Anxiety Disorder
PH94B is one of a new class of Pherin proprietary compounds called pherines. With intranasal spray administration, it acts locally on peripheral receptors from nasal chemosensory neurons that connect to the hypothalamic-limbic areas of the brain. This mechanism of pharmacological action, the rapid onset of effect, and the excellent safety and tolerability profile make PH94B an excellent product candidate for the acute treatment of patients with Social Anxiety Disorder.
Social Anxiety Disorder, also called Social Phobia, is reportedly the most common anxiety disorder, with a lifetime prevalence of 13-14%. Social Anxiety Disorder is characterized by a persistent and unreasonable fear of one or more social or performance situations, where the individual fears that he or she will act in a way or show symptoms that will be embarrassing or humiliating, leading to avoidance of the situations when possible and anxiety or distress when they occur. There are two types: generalized Social Anxiety Disorder, where the fears are related to both social and performance situations; and discrete Social Anxiety Disorder, where the fears are related to particular performance anxiety situations only, such as public speaking. These fears can have a significant impact on the person's employment, social activities and overall quality of life. Social Anxiety Disorder is commonly treated chronically with antidepressants, which have a slow onset of action and side effects that may make them unattractive to sufferers from Social Phobia. There are no acute treatments for generalized Social Anxiety Disorder; and the current acute treatments for discrete Social Anxiety Disorder are beta-blockers, which must be taken 30-60 minutes before the expected time of the performance situation and are associated with their own side effects.
Pherin Pharmaceuticals, Inc. of Los Altos, California, is a clinical stage drug development company that has developed a family of leading and innovative proprietary compounds called pherines that bind to peripheral receptors in the nasal passages that affect the hypothalamus and the limbic system and induce proven behavioral, neuropsychiatric and neuroendocrine effects in humans. Among Pherin's extensive library of pherines there are molecules being studied for their potential therapeutic application including treatment of depression, premenstrual dysphoric disorder and cognition enhancement.
Pherin is the leader in the development of pherines, having pioneered breakthrough discoveries of the behavioral and neuroendocrine effects of a large number of pherines that can be administered airborne to the nasal passages in nanogram or low microgram range. Pherin's mission is to improve people's lives by pioneering novel healthcare products that make distinct improvements over other treatments.
This press release contains certain forward-looking statements relating to Pherin and the future development of PH94B, its safety and effectiveness in treating Social Phobia, and its patent position. Such forward-looking statements reflect the current views of Pherin regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with PH94B to be materially different from any future results, performance or achievements expressed or implied by such statements.
Dr. Louis Monti
Pherin Pharmaceuticals, Inc.
SYS-CON Events announced today that Pulzze Systems 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. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Sep. 25, 2016 06:45 AM EDT Reads: 1,726
SYS-CON Events announced today the Enterprise IoT Bootcamp, being held November 1-2, 2016, in conjunction with 19th Cloud Expo | @ThingsExpo at the Santa Clara Convention Center in Santa Clara, CA. Combined with real-world scenarios and use cases, the Enterprise IoT Bootcamp is not just based on presentations but with hands-on demos and detailed walkthroughs. We will introduce you to a variety of real world use cases prototyped using Arduino, Raspberry Pi, BeagleBone, Spark, and Intel Edison. Y...
Sep. 25, 2016 06:30 AM EDT Reads: 2,794
Most of us already know that adopting new cloud applications can boost a business’s productivity by enabling organizations to be more agile and ready to change course in our fast-moving and connected digital world. But the rapid adoption of cloud apps and services also brings with it profound security threats, including visibility and control challenges that aren’t present in traditional on-premises environments. At the same time, the cloud – because of its interconnected, flexible and adaptable...
Sep. 25, 2016 05:45 AM EDT Reads: 1,601
Technology vendors and analysts are eager to paint a rosy picture of how wonderful IoT is and why your deployment will be great with the use of their products and services. While it is easy to showcase successful IoT solutions, identifying IoT systems that missed the mark or failed can often provide more in the way of key lessons learned. In his session at @ThingsExpo, Peter Vanderminden, Principal Industry Analyst for IoT & Digital Supply Chain to Flatiron Strategies, will focus on how IoT de...
Sep. 25, 2016 05:30 AM EDT Reads: 976
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
Sep. 25, 2016 04:45 AM EDT Reads: 1,498
SYS-CON Events announced today that China Unicom 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. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
Sep. 25, 2016 04:15 AM EDT Reads: 1,678
SYS-CON Events announced today that Roundee / LinearHub will exhibit at the WebRTC Summit at @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LinearHub provides Roundee Service, a smart platform for enterprise video conferencing with enhanced features such as automatic recording and transcription service. Slack users can integrate Roundee to their team via Slack’s App Directory, and '/roundee' command lets your video conference ...
Sep. 25, 2016 04:15 AM EDT Reads: 1,380
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Sep. 25, 2016 03:15 AM EDT Reads: 3,349
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Sep. 25, 2016 03:00 AM EDT Reads: 1,470
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Sep. 25, 2016 02:45 AM EDT Reads: 1,709
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
Sep. 25, 2016 02:45 AM EDT Reads: 874
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...
Sep. 25, 2016 02:15 AM EDT Reads: 1,211
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Sep. 25, 2016 12:45 AM EDT Reads: 1,036
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
Sep. 25, 2016 12:45 AM EDT Reads: 1,929
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
Sep. 25, 2016 12:30 AM EDT Reads: 1,600