Welcome!

News Feed Item

Pherin Pharmaceuticals Reports Favorable Clinical, Regulatory, and Intellectual Property Actions on Novel Intranasal Medication for Acute Treatment of Social Anxiety Disorder and Issuance of Patents in the U.S.A. and Other Major Countries

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.

Regulatory Interaction
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.

Intellectual Property
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.

About Pherin
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.

Disclaimer
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.

CONTACT:

Dr. Louis Monti
Pherin Pharmaceuticals, Inc.
(650) 961-2080
Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
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.
Designing IoT applications is complex, but deploying them in a scalable fashion is even more complex. A scalable, API first IaaS cloud is a good start, but in order to understand the various components specific to deploying IoT applications, one needs to understand the architecture of these applications and figure out how to scale these components independently. In his session at @ThingsExpo, Nara Rajagopalan is CEO of Accelerite, will discuss the fundamental architecture of IoT applications, ...
Cloud-based NCLC (No-code/low code) application builder platforms empower everyone in the organization to quickly build applications and executable processes that broaden access, deepen collaboration, and enhance transparency for all team members. Line of business owners (LOBO) and operations managers know best their part of the business and their processes. IT departments are beginning to leverage NCLC platforms to empower and enable LOBOs to lead the innovation, transform the organization, an...
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...
@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.
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
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...
SYS-CON Events announced today that MangoApps 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. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
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...
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 ...
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...
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 ...
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 ...
SYS-CON Events announced today that Hanu Software 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. Leveraging best-in-class people, processes, and technologies, Hanu provides high-quality, high-value software development and business process outsourcing services to independent software vendors (ISVs) and enterprises.