Cynapsus Therapeutics Inc.: Cynapsus Therapeutics Awarded Grant from The Michael J. Fox Foundation for Clinical …

TORONTO--(Marketwire -08/08/12)- Cynapsus Therapeutics Inc. (CTH:TSX-V) today announced that it has been awarded a grant of USD$947,925 from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support clinical studies to develop APL-130277, a sublingual (oral) thin film strip reformulation of apomorphine. Apomorphine is an approved drug in the US, Europe and several other countries as a subcutaneous injection or infusion for Parkinson's patients experiencing daily "OFF" or motor fluctuation episodes. APL-130277 is potentially the only oral formulation of Apomorphine, and as such will provide patients with a convenient and more tolerable alternative to multiple daily injections.

The grant was awarded under the Foundation's The Edmond J. Safra Core Programs for Parkinson's Research, Clinical Intervention Award, aimed at supporting human clinical trials testing promising Parkinson's therapies that may significantly and fundamentally improve treatment for people with Parkinson's.

"Improved methods of delivery for apomorphine, which has been shown to effectively treat 'off-episodes' in motor fluctuation, have been a goal of pharmaceutical research for at least a decade," says Maurizio Facheris, MD, MSc, Associate Director of Research Programs at MJFF. "Preliminary data around Cynapsus' novel formulation (APL-130277) show promise for a more frequent and effective use of this dopaminergic drug. We are hopeful that these clinical studies will support this promise, and drive APL-130277 further along the pipeline of therapeutic development."

"We are grateful to The Michael J. Fox Foundation, as well as their internal and external reviewers, for having judged our APL-130277 project to be worthy of support," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. "We are optimistic that APL-130277 has the potential to help many of the existing Parkinson's patients manage their daily quality of life, the use of caregivers and the use of their Levodopa treatments."

Dr. Albert Agro, the Principal Investigator for the study and the Chief Medical Officer of Cynapsus added: "The Foundation's support with this pre-bioequivalence clinical study will be instrumental in helping us complete the requirements recommended by the US FDA in our Pre-IND meeting. We have confidence that our sublingual film strip will succeed in achieving a pharmacokinetic profile that will satisfy requirements of the US FDA's 505(b)2 approval process and lead to a timely NDA submission sometime in 2014."

About APL-130277 and Apomorphine

Apomorphine is a highly under-utilized medication in Parkinson's disease. Despite its very strong efficacy and rapid onset of action, patients find injections painful and delay or resist use of the drug until the very latest stages of Parkinson's disease progression. Physicians find the initiation of dosing cumbersome because of (a) an in-clinic procedure to determine tolerability to the drug and (b) training of patients in the use of the subcutaneous (sc) injection pen device. Eliminating some of these barriers are key objectives of Cynapsus' APL-130277.

APL-130277 is an innovative, fast-dissolving, sublingually-administered thin-film product for use as rescue medication for intermittent OFF episodes in Parkinson's disease. The product is easy to self-administer under the tongue and dissolves immediately in saliva. The result is a fast and reliable uptake of the drug and pharmacokinetics (i.e. the amount of drug in a specified period of time) that closely mimic the injection, but without the needle or scarring and inflammation associated with the injection.

Cynapsus has tested prototype optimizations in-vivo PK models and a lead candidate was selected. A Pilot PK Study (CTH101) completed in December 2011 measured the pharmacokinetic profile of a single 3mg dose APL-130277 in 15 Healthy Volunteers. APL-130277 showed a rapid onset of absorption and PK profile similar to the injection form of the drug. Results of a second Pilot PK Study (CTH102) are expected to be available by September 2012.

About Parkinson's Disease

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