TORONTO, ONTARIO–(Marketwire – May 30, 2012) – Cynapsus Therapeutics Inc. (CTH.V – News), a specialty pharmaceutical company developing an improved dosing formulation of an approved drug used to treat the symptoms of Parkinson’s disease, today announced its results for the three months ended March 31, 2012. Unless specified otherwise, all amounts are in Canadian dollars.
“In the first quarter our team continued to make significant progress on our lead drug candidate, APL-130277,” said Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus. “In particular, the first quarter was highlighted by the announcement of the completion of the first human clinical trial for APL-130277. Building on this success, we remain focused on the completion of a second dose escalation study in the next 60-90 days, as well as preparations for an Investigational New Drug Application to the US FDA for a clinical BioEquivalence study later in the year. The BEQ study is the next critical de-risking milestone that we believe will drive significant shareholder value.”
Financial Highlights
Recent Developments
The following achievements were made during the quarter:
Cynapsus Completed the First Human Volunteer Pilot Proof-of-Concept Clinical Trial For APL-130277. On January 10, 2012, Cynapsus announced positive headline data from its recently completed human volunteer pilot proof-of-concept trial for APL-130277, a sublingual thin film strip formulation of apomorphine. The study showed a pharmacokinetic (PK) profile that compared favorably to injected apomorphine with a mean T-max of 25 minutes and good tolerability, and therefore confirms that APL-130277 has the potential to treat motor fluctuations or “off episodes” in Parkinson’s disease. This was a significant milestone and de-risking event for the project.
Cynapsus Obtained Independent Research Coverage. In February 2012, the Company announced that Loewen, Ondaatje, McCutcheon Limited (“LOM”) initiated analyst coverage of the Company. LOM’s biotech analyst initiation of research coverage provides further independent opinion and view of the strengths, risks and commercial potential of APL-130277.
Cynapsus Added an Additional Expert to the Clinical Advisory Board (“CAB”). During the quarter, Management initiated a search for new CAB candidates that have extensive experience in the clinical management of Parkinson’s patients. In April 2012, subsequent to the end of the quarter, the Company announced that it has appointed Dr. Abraham Lieberman to the CAB. Dr. Lieberman is the current Director of the Muhammad Ali Parkinson Center and Movement Disorder Clinic of the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Arizona.
Cynapsus Initiated Discussions to Strengthen the Board of Directors. During the quarter, the Board initiated a search for new Board candidates. In May 2012, subsequent to the end of the quarter, the Company announced that Dr. Perry Molinoff, Dr. Thomas Picone, and Anthony Giovinazzo, were named as candidates to join its Board of Directors at the May 30, 2012 Annual and Special Meeting of Shareholders. Mr. Giovinazzo and Dr. Molinoff were nominated and elected to the Board at the meeting held earlier in the day, along with Mr. Ronald Hosking, Dr. Julia Levy, Dr. Alan Ryley, Ms. Rochelle Stenzler and Mr. Alan Torrie. Dr. Picone was not nominated today for personal reasons, however his candidacy is still in process and he may join the Board of Directors in the next three months, subject to Board and Exchange approval.
Cynapsus Commenced Work on the Second Human Volunteer Pilot Proof-of-Concept Clinical Trial For APL-130277. During the quarter, the Company began work on a second Phase 1 healthy human volunteer pilot study to provide additional insights related to a two dose comparison, as well as some minor changes to the prototype composition. This pilot study commenced in May 2012, subsequent to the end of the quarter, with results expected to be announced in July or August 2012.
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Cynapsus Therapeutics Reports First Quarter 2012 Financial Results and Recent Developments
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