Welcome!

News Feed Item

Cynapsus Therapeutics Awarded Second Grant from The Michael J. Fox Foundation for Parkinson's Research

TORONTO, ONTARIO -- (Marketwired) -- 07/08/14 -- Cynapsus Therapeutics Inc. (TSX VENTURE:CTH)(OTCQX:CYNAF) today announced that it has been awarded a new grant of US$500,000 from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support clinical studies to develop APL-130277, a sublingual thin film strip reformulation of apomorphine. This second MJFF grant will be used to fund the Company's CTH-105 clinical study.

APL-130277 is an easy-to-administer, fast-acting and proprietary reformulation of apomorphine for sublingual delivery. Injectable apomorphine is the only approved drug in the United States, Europe, Japan and other countries for the acute rescue of "off" motor symptoms of Parkinson's disease. The APL-130277 thin film strip system technology is specifically designed to provide enhanced convenience and eliminate buccal mucosal irritation, among other attributes.

CTH-105 is a pilot study in patients with Parkinson's disease who are naive to the use of apomorphine and who experience at least one daily "off" episode with a total duration of "off" in any 24-hour period of at least 2 hours. This study is planned to examine the effect of APL-130277 on relieving "off" episodes over a single day with a dose-titration used to determine dose strengths necessary for future clinical development. This study and future trials of APL-130277 will be listed on Fox Trial Finder, an online tool from MJFF matching interested research volunteers with recruiting clinical studies.

"The options for patients living with 'off' episodes are limited and unfavorable," says Maurizio Facheris, MD, MSc, Associate Director of Research Programs at MJFF. "Initial results of Cynapsus' novel formulation (APL-130277) show this therapy may offer not only a more palatable solution for motor fluctuations, but also a longer window of efficacy, thereby postponing dopamine replacement dosing and lessening associated side effects."

"This second grant from The Michael J. Fox Foundation is very important to Cynapsus, as it solidifies the partnership we have forged with the Foundation to focus on improving the daily lives of Parkinson's patients," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "The CTH-105 clinical trial is our first in Parkinson's patient study of APL-130277 and will assist us with dosing information required for the CTH-300a registration study, which is expected to begin in Q4 2014."

Dr. Albert Agro, the Principal Investigator for the study and the Chief Medical Officer of Cynapsus added: "The continued support of The Michael J. Fox Foundation validates our clinical approach and justifies the need for an improved formulation of apomorphine in the form of APL-130277. With the help of the MJFF, we are excited about moving APL-130277 in to patients this summer in the CTH-105 Phase 2 study."

The MJFF previously awarded Cynapsus an initial grant of USD$947,925 to complete a comparative study of APL-130277 (i.e. CTH-103) versus subcutaneous injection. The results of the CTH-103 study were announced on January 13, 2014.

Support for Future Parkinson's Research

Parkinson's disease is a chronic, degenerative neurological disorder that results from the loss of dopamine-producing nerve cells in the brain. Current treatments for Parkinson's disease are able to reduce the symptoms of the disease but are not able to treat the underlying neurodegenerative processes. It is estimated that over one million people in the United States and 4 to 6 million people globally are living with Parkinson's disease. According to the U.S. National Institute of Neurodegenerative Disease and Stroke, the average age of onset is 60, though some people are diagnosed at age 40 or younger.

As part of the MJFF grant agreement, Cynapsus has made a commitment to support further Parkinson's research by making up to $1 million in contributions to MJFF based on future potential sales of APL-130277.

About Apomorphine

Apomorphine, a potent dopamine agonist, is the only drug approved specifically for the treatment of acute motor fluctuations/hypomobility (freezing or "off" episodes) in patients with advanced Parkinson's disease. Presently, apomorphine is administered by intermittent subcutaneous injection usually via a pre-filled injection pen, or, in some cases outside the United States, by continuous infusion pump. Drawbacks associated with subcutaneous injection therapy for patients and caregivers include aversion to needles, the need for multiple injections, which can be painful and are often associated with irritation and inflammation at the injection site, and the requirement for a degree of manual dexterity that some Parkinson's patients find difficult.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from "off" episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application ("NDA") expected to be submitted in 2016.

Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Corporation's Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of Parkinson's patients experience "off" episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease's symptoms, and most drugs become less effective over time as the disease progresses.

More information about Cynapsus (TSX VENTURE:CTH)(OTCQX:CYNAF) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.

Forward-Looking Statements

This announcement contains "forward-looking statements" within the meaning of applicable securities laws. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved". Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Cynapsus to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks and uncertainties relating to Cynapsus' business disclosed under the heading "Risk Factors" in its March 26, 2014, Annual Information Form and its other filings with the various Canadian securities regulators which are available online at www.sedar.com. Although Cynapsus has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Cynapsus does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.

Neither the TSX Venture Exchange nor the OTCQX International has approved or disapproved the contents of this press release.

Contacts:
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]

Cynapsus Therapeutics
Albert Agro
Chief Medical Officer
(416) 703-2449 x252
[email protected]
www.cynapsus.ca

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
ICC is a computer systems integrator and server manufacturing company focused on developing products and product appliances to meet a wide range of computational needs for many industries. Their solutions provide benefits across many environments, such as datacenter deployment, HPC, workstations, storage networks and standalone server installations. ICC has been in business for over 23 years and their phenomenal range of clients include multinational corporations, universities, and small busines...
The current environment of Continuous Disruption requires companies to transform how they work and how they engineer their products. Transformations are notoriously hard to execute, yet many companies have succeeded. What can we learn from them? Can we produce a blueprint for a transformation? This presentation will cover several distinct approaches that companies take to achieve transformation. Each approach utilizes different levers and comes with its own advantages, tradeoffs, costs, risks, a...
This session describes how Professional Services organisations can deliver within Technology-as-a-Service (IaaS) constructs, in private and public enterprise cloud scenarios. See how professional services can be packaged and funded by IaaS cash flows, based upon consumption of technology services. Learn how significant, IT infrastructure transformations can be funded through OPEX spending models with multi-year As-a-Services based contracts. Understand how the automation of repeatable services c...
This sixteen (16) hour course provides an introduction to DevOps, the cultural and professional movement that stresses communication, collaboration, integration and automation in order to improve the flow of work between software developers and IT operations professionals. Improved workflows will result in an improved ability to design, develop, deploy and operate software and services faster.
Enterprises are universally struggling to understand where the new tools and methodologies of DevOps fit into their organizations, and are universally making the same mistakes. These mistakes are not unavoidable, and in fact, avoiding them gifts an organization with sustained competitive advantage, just like it did for Japanese Manufacturing Post WWII.
Most modern computer languages embed a lot of metadata in their application. We show how this goldmine of data from a runtime environment like production or staging can be used to increase profits. Adi conceptualized the Crosscode platform after spending over 25 years working for large enterprise companies like HP, Cisco, IBM, UHG and personally experiencing the challenges that prevent companies from quickly making changes to their technology, due to the complexity of their enterprise. An accomp...
Cloud computing is a goal aspired to by all organizations, yet those in regulated industries and many public sector organizations are challenged in adopting cloud technologies. The ability to use modern application development capabilities such as containers, serverless computing, platform-based services, IoT and others are potentially of great benefit for these organizations but doing so in a public cloud-consistent way is the challenge.
The digital transformation is real! To adapt, IT professionals need to transform their own skillset to become more multi-dimensional by gaining both depth and breadth of a wide variety of knowledge and competencies. Historically, while IT has been built on a foundation of specialty (or "I" shaped) silos, the DevOps principle of "shifting left" is opening up opportunities for developers, operational staff, security and others to grow their skills portfolio, advance their careers and become "T"-sh...
"Calligo is a cloud service provider with data privacy at the heart of what we do. We are a typical Infrastructure as a Service cloud provider but it's been designed around data privacy," explained Julian Box, CEO and co-founder of Calligo, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, described how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launching o...
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee A...
Bill Schmarzo, Tech Chair of "Big Data | Analytics" of upcoming CloudEXPO | DXWorldEXPO New York (November 12-13, 2018, New York City) today announced the outline and schedule of the track. "The track has been designed in experience/degree order," said Schmarzo. "So, that folks who attend the entire track can leave the conference with some of the skills necessary to get their work done when they get back to their offices. It actually ties back to some work that I'm doing at the University of San...
Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of business. Only 12% still survive. Similar percentages are found throughout enterprises of all sizes. We are offering early bird savings...
Digital transformation is about embracing digital technologies into a company's culture to better connect with its customers, automate processes, create better tools, enter new markets, etc. Such a transformation requires continuous orchestration across teams and an environment based on open collaboration and daily experiments. In his session at 21st Cloud Expo, Alex Casalboni, Technical (Cloud) Evangelist at Cloud Academy, explored and discussed the most urgent unsolved challenges to achieve fu...
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed 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 at D...