Welcome!

News Feed Item

Cynapsus Announces Interim Summary Results of Human Healthy Volunteer Single 25mg Study for APL-130277

Results Support Higher Drug Concentration in the Blood as a Result of Higher Dose Strip

TORONTO, ONTARIO -- (Marketwired) -- 03/28/14 -- Cynapsus Therapeutics Inc. (TSX VENTURE: CTH)(OTCQX: CYNAF), a specialty pharmaceutical company, today announced positive interim data from its recently completed healthy volunteer pilot study of a single 25mg sublingual strip (APL-130277) dose of apomorphine. 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. The interim CTH-104 study results indicate that a higher load of drug on the strip does result in a higher amount of drug entering the blood stream.

Mr. Anthony Giovinazzo, President and CEO of Cynapsus commented, "Results from the first group of subjects of the CTH-104 clinical study are an important de-risking event for our product and set the stage for identifying efficacious doses for our upcoming clinical studies in 2014. We are encouraged that the 25mg strip was safe and well tolerated. Further, a significantly higher amount of drug accumulated in the blood stream as compared to the 10mg and 15mg strips that were tested in our CTH-103 study. This interim data shows that the APL-130277 strip can provide a concentration of apomorphine in the blood associated with an expected minimum efficacious concentration (i.e. approximately 3ng/ml) for over 2 hours, therefore potentially providing a significant reversal of the "off" state for patients with Parkinson's disease."

Dr. Albert Agro, Chief Medical Officer at Cynapsus, also commented: "The early PK and safety data from CTH-104 confirms that our formulation has both the potential for clinical efficacy and safety advantages over the sub-cutaneous injection of apomorphine. We look forward to the initiation of the upcoming clinical program assessing the effectiveness of APL-130277 in patients with Parkinson's disease."

CTH-104 Clinical Trial Design and Results

Background

As reported on January 13, 2104, the third cohort of the CTH-103 study was designed to compare the 25mg sublingual thin film strip (APL-130277) to the 4mg subcutaneous injection. This third cohort could not be dosed due to the dose-limiting adverse events experienced with the 3mg subcutaneous injection. The 15mg sublingual strip (APL-130277), which was the corresponding dose to the 3mg subcutaneous injection, resulted in side effects that were mild-to-moderate and not dose limiting.

The current CTH-104 study is a single dose, single arm, placebo-controlled, healthy volunteer pharmacokinetic study, which is designed to examine the pharmacokinetic profile of the 25mg dose of APL-130277.

The study is designed to include 16 healthy human volunteers (two placebo and 14 active). Nine (9) of the sixteen (16) subjects were completed in the first group, reported herein. The remaining subjects will be dosed and analysed within the next 15-30 days, at which point the combined data will be released.

Key Findings


--  Comparing the increased dose of the 25mg (APL-130277) strip used in CTH-
    104 to that of the 15mg strip previously used in CTH-103, indicates that
    a higher concentration of apomorphine was achieved. In this first group
    of subjects, sublingual delivery of the higher 25mg strip dose resulted
    in more adverse events with a greater severity than seen with the 15 mg
    dose. The side effects were mild to moderate and were not defined to be
    dose limiting.

--  In this first group of subjects, the PK profile of the 25mg APL-130277
    dose strip indicates that exposure increased as compared to 15mg strip
    and achieved a concentration associated with an expected minimum
    efficacious concentration (i.e. approximately 3ng/ml) for over 2 hours.

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.

Critical Next Steps

For development of APL-130277 in the United States, the Corporation will follow the 505(b)(2) regulatory pathway. Specifically, the Corporation is pursuing the reformulation of apomorphine from a subcutaneous injection to a convenient and more tolerable and safe sublingual thin film strip. The drug being delivered (apomorphine) is identical to the drug used in the injection, and its use will be intended as an acute rescue therapy for Parkinson's patients experiencing acute, intermittent hypomobility (i.e. "off" episodes) associated with advanced Parkinson's disease, which is the description of the use of apomorphine in the current US approved label.

The 505(b)(2) pathway will require that the Corporation provide statistically sufficient clinical evidence that Parkinson's patients experience management of their "off" episodes, as a result of delivery of apomorphine via the sublingual thin film strip route. The primary end point will be based on changes in the Unified Parkinson's Disease Rating Scale Part III (UPDRS III) movement score. In addition, the Corporation will be required to provide in a separate study, statistically sufficient clinical evidence that administering apomorphine via a sublingual thin film route results in Parkinson's patients experiencing low to no oral irritation as a result of multiple daily exposures to the drug for an extended period.

To achieve this, the Corporation currently expects to complete the following clinical studies:


1.  CTH-105 Pilot Study.  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. The CTH-105 study is expected to begin in mid-2014
    subsequent to the acceptance of an Investigational New Drug (IND)
    application by the FDA. CTH-105 is expected to be completed by the end
    of Q3 2014.

2.  CTH-200 Bridging Study. A single dose, crossover comparative
    bioavailability and PK study in healthy volunteers. This study is
    designed to provide the clinical "bridge" to the FDA's finding of safety
    and efficacy for the Reference Listed Drug (s.c. Apomorphine). The CTH-
    200 Bridging Study is expected to begin in mid-2014 subsequent to
    completion of CTH-105. It is expected to be complete by end of Q3 2014
    and is required under the FDA's 505(b)(2) regulations to demonstrate
    comparability to the reference listed drug.

3.  CTH-300a Efficacy Study in apomorphine naive patients. A double-blind,
    placebo-controlled, parallel-design study with Parkinson's patients who
    have at least one "off" episode every 24 hours, with total "off" time of
    at least 2 hours. The primary end point will be the change in the UPDRS
    III score.

4.  CTH-300b Efficacy Study in apomorphine experienced patients.  A double
    blind, placebo controlled, crossover-designed study with Parkinson's
    patients who are presently controlled with the use of apomorphine. The
    primary end point will be the change in the UPDRS III score. Upon
    successful completion of CTH-300a and CTH-300b, the Corporation will
    provide the results to the FDA and request a meeting to seek final
    guidance for the design of Safety Study (CTH-301).

5.  CTH-301 Safety Study.  A long-term safety study in apomorphine naive
    Parkinson's patients who have at least one "off" episode every 24 hours,
    with total "off" time of at least 2 hours. The Safety Study is expected
    to start in early 2015 and be completed by the end of 2015. The study
    will specifically look at the safety and tolerability of the new
    delivery route over a minimum period of 16 weeks.

The above clinical development plan has been vetted with both clinical experts and regulatory consultants who have expertise in overseeing FDA 505(b)(2) submissions to the Agency.

In parallel to the studies described above, the Corporation will be performing the necessary scale-up, process validation and stability as part of the Chemistry, Manufacturing and Controls ("CMC") requirements for the filing of the NDA. Accordingly, all development will be performed according to current Good Manufacturing Practices ("cGMP") methodology.

Upon completion of the efficacy and safety studies, as well as the CMC section, the Corporation expects will begin preparation of a FDA 505(b)(2) NDA in 2016.

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 Company's Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of 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 latest 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 of the TSX Venture Exchange or OTCQX has approved or disapproved the contents of this press release.

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
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
In his session at @ThingsExpo, Eric Lachapelle, CEO of the Professional Evaluation and Certification Board (PECB), will provide an overview of various initiatives to certifiy the security of connected devices and future trends in ensuring public trust of IoT. Eric Lachapelle is the Chief Executive Officer of the Professional Evaluation and Certification Board (PECB), an international certification body. His role is to help companies and individuals to achieve professional, accredited and worldw...
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
SYS-CON Events announced today that Infranics will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Since 2000, Infranics has developed SysMaster Suite, which is required for the stable and efficient management of ICT infrastructure. The ICT management solution developed and provided by Infranics continues to add intelligence to the ICT infrastructure through the IMC (Infra Management Cycle) based on mathemat...
SYS-CON Events announced today that SD Times | BZ Media has been named “Media Sponsor” of SYS-CON's 20th International Cloud Expo, which will take place on June 6–8, 2017, at the Javits Center in New York City, NY. BZ Media LLC is a high-tech media company that produces technical conferences and expositions, and publishes a magazine, newsletters and websites in the software development, SharePoint, mobile development and commercial UAV markets.
SYS-CON Events announced today that Cloudistics, an on-premises cloud computing company, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloudistics delivers a complete public cloud experience with composable on-premises infrastructures to medium and large enterprises. Its software-defined technology natively converges network, storage, compute, virtualization, and management into a ...
Now that the world has connected “things,” we need to build these devices as truly intelligent in order to create instantaneous and precise results. This means you have to do as much of the processing at the point of entry as you can: at the edge. The killer use cases for IoT are becoming manifest through AI engines on edge devices. An autonomous car has this dual edge/cloud analytics model, producing precise, real-time results. In his session at @ThingsExpo, John Crupi, Vice President and Eng...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., will discuss how these tools can be leveraged to develop a lasting competitive advanta...
SYS-CON Events announced today that HTBase will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. HTBase (Gartner 2016 Cool Vendor) delivers a Composable IT infrastructure solution architected for agility and increased efficiency. It turns compute, storage, and fabric into fluid pools of resources that are easily composed and re-composed to meet each application’s needs. With HTBase, companies can quickly prov...
There are 66 million network cameras capturing terabytes of data. How did factories in Japan improve physical security at the facilities and improve employee productivity? Edge Computing reduces possible kilobytes of data collected per second to only a few kilobytes of data transmitted to the public cloud every day. Data is aggregated and analyzed close to sensors so only intelligent results need to be transmitted to the cloud. Non-essential data is recycled to optimize storage.
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold 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. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists discussed how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations might...