Cynapsus Therapeutics Provides Research Update for Parkinson's Drug Candidate
Product News Jun 27, 2011
Cynapsus Therapeutics Inc., has 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."
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.