NEW YORK, NY--(Marketwired - Feb 7, 2014) - LifeSci Advisors, LLC announcement for Cynapsus Therapeutics, Inc. (TSX VENTURE: CTH) (OTCQX: CYNAF)
- Sublingual Apomorphine Therapy Designed to Treat Parkinson's Disease Freezing Episodes
- Following Positive Phase I Results, Cynapsus is Pursuing 505(b)(2) Approval for APL-130277
- Report Available for Download at http://www.lifesciadvisors.com/clients/cynapsus/
LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Cynapsus Therapeutics, Inc. (TSX VENTURE: CTH) (OTCQX: CYNAF), a company developing APL-130277, a unique thin-film sublingual formulation of apomorphine to treat freezing episodes in Parkinson's disease. The sublingual strip is intended to replace a painful subcutaneous injection that is currently the only available rescue therapy for these episodes. The Company recently reported positive results from a Phase I pharmacokinetic study. Pivotal efficacy studies in apomorphine-naïve and apomorphine-experienced PD patients are expected to begin in the fourth quarter of 2014, followed by a safety study in 2015, leading to a potential regulatory filing in early 2016.
"The sublingual strip that Cynapsus is developing has the potential to substantially improve the treatment of 'off' episodes for Parkinson's patients while also helping them avoid painful injections," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "Injection site reactions and the difficulty of self-administration have hampered subcutaneous apomorphine, and created an unmet medical need. The sublingual formulation has much greater potential to penetrate the market."
On January 13 Cynapsus reported positive results from a Phase I, CTH-103, comparing the pharmacokinetic profile of three doses of sublingual apomorphine to subcutaneous injections. Results showed a stronger safety profile for APL-130277 as compared to subcutaneous injection, which should enable Cynapsus to pursue a differentiated label from injectable apomorphine with possibly better safety claims under 505(b)(2) regulatory approval.
In a 35 page Initiation Report by LifeSci Advisors, we explain the potential advantages of Cynapsus' sublingual formulation of apomorphine over the subcutaneous injection and other products in development. The report explores the scientific basis for using apomorphine to treat 'off' episodes in Parkinson's disease patients. The addressable market is discussed, as well as the potential for APL-130277 to increase the number of patients using apomorphine to treat these episodes.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
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