Cynapsus Therapeutics Inc.
TSX VENTURE : CTH

Cynapsus Therapeutics Inc.

June 24, 2011 09:35 ET

Cynapsus Therapeutics Provides Research Update for Parkinson's Drug Candidate

TORONTO, ONTARIO--(Marketwire - June 24, 2011) - Cynapsus Therapeutics Inc. (TSX VENTURE:CTH), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson's disease, today provided an update on the progress of its research activities on its lead drug candidate, APL-130277.

In providing the update, Anthony Giovinazzo, President and Chief Executive Officer, said: "I am pleased to report that our most recent drug prototypes have achieved a significant reduction in time to achieve maximum serum concentration (Tmax) of drug in the blood stream, as tested in validated animal models. As a result, we believe our latest prototypes may deliver more promising results in clinical testing in man. Over the next 6 months, our primary goal is to successfully complete a Phase 1 pharmacokinetic clinical study in healthy volunteers to further de-risk the project."

Recent Developments

Improved Product Prototypes: Over the past 3 months, Cynapsus continued development of new prototypes of APL-130277 in collaboration with an experienced cGMP thin-film manufacturer. Key improvements include advances in processing methodology, further increasing the speed of dissolution and the rate of absorption of the main active pharmaceutical ingredient, apomorphine hydrochloride. As a result, Cynapsus has a new lead-product candidate with a pharmacokinetic (PK) profile that is nearly identical to that of the FDA-approved injectable delivery of apomorphine hydrochloride. These results are important as they support our premise that APL-130277 thin-film strips provide efficacious serum levels that match closely the US FDA criteria for a 505(b)(2) submission.

Successful Meeting with US Food and Drug Administration (FDA): In April, Cynapsus held a successful Pre-IND Meeting with the US FDA in Washington, DC, to discuss preliminary clinical plans for APL-130277, an apomorphine thin film strip formulation for the rescue of patients experiencing "OFF" periods in Parkinson's disease. The outcome of the meeting was positive, and the Company expects to enter its first human clinical trials of APL-130277 in the second half of 2011.

Refined Clinical Trial Plans and Vendor Selection: Over the past 3 months, Request-for-Proposals were sent to several experienced and qualified US-based Contract Research Organizations (CRO) who have expressed interest in conducting upcoming Phase 1 and Pivotal clinical studies. Site visits are planned and CRO selection is expected to occur in the next couple of months. Vendors for all other clinical services such as PK analysis and stats, report writing, etc. will also be made shortly.

About Parkinson's Disease and APL-130277

In the United States alone, approximately 4 million new Americans will turn 65 each year for the next 19 years. This demographic is the primary age group for development of neurodegenerative diseases such as Alzheimer's and Parkinson's disease. It is estimated that there are approximately 6 million Parkinson's disease patients in the world today.

Discovery of disease modifying therapies for chronic brain conditions such as Parkinson's disease and Alzheimer's disease based on early diagnosis, genetic manipulation, and/or cell therapy are more than 10 to 15 years away. Further research will be required to make such therapies practical, economical, and broadly available. As a result, effective and economical therapies that relieve symptoms, such as APL 130277, will remain a mainstay in treating patients and will address substantial unmet medical needs.

For patients with Parkinson's disease, Apomorphine is a fast-acting, effective dopamine agonist to treat off episodes, i.e. periods when chronic Parkinson's patients experience impaired movement or speaking capabilities. Apomorphine is currently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), but is currently only available by subcutaneous injection.

APL-130277 has the potential to be the first marketed convenient oral (sublingual) formulation of apomorphine, a drug proven to work even in the most severe cases of Parkinson's disease in which other drugs have diminished effect. APL-130277 is being developed as a once to three times a day rescue therapy, to be used adjunctive to levodopa combination therapies.

As a drug development project, APL-130277 has a lower risk profile than a New Chemical Entity given that the regulatory path is shorter and well-defined, the cost to an approvable New Drug Application (NDA) is relatively low (estimated at approximately $20 million), and the active compound has a well known efficacy and safety profile. If APL 130277 demonstrates "therapeutic equivalence" in its abbreviated 2 year clinical program, the Company, or a pharmaceutical partner, would be allowed under the US FDA regulations, to submit a New Drug Approval request, based on the 505b(2) criteria. These criteria would recognize the subcutaneous injection (NDA 21-264) as the reference listed drug to which APL 130277 would draw safety and efficacy data and would be compared by the US FDA.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of 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. 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.

Cynapsus' lead drug candidate, APL-130277, is an easy-to-administer, fast-acting and oral reformulation of an approved drug, apomorphine, used to rescue patients from off episodes. Cynapsus is focused on rapidly maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2013 or 2014. The Company anticipates out-licensing to an appropriate pharmaceutical partner before such an application is submitted.

More information about Cynapsus (TSX VENTURE:CTH) 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 press release contains "forward-looking statements" within the meaning of applicable Canadian securities legislation. 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 Cynapsus' current 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.

The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.

Contact Information