|By Marketwired .||
|August 13, 2014 06:01 AM EDT||
TORONTO, ONTARIO -- (Marketwired) -- 08/13/14 -- Cynapsus Therapeutics Inc. (TSX VENTURE: CTH)(OTCQX: CYNAF), a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease, today announced its results for the three and six months ended June 30, 2014. Unless specified otherwise, all amounts are in Canadian dollars.
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated: "The second quarter of 2014 was highlighted by the closing of a transformational $25,000,000 financing in April 2014. Management is now focused on the execution of three clinical studies of APL-130277, which are expected to be completed over the next 6 months: (1) the CTH-105 pilot study in patients with Parkinson's disease in Q3 2014; (2) the CTH-200 bioavailability study in Q4 2014; and (3) the CTH-300a efficacy study in apomorphine naive patients in Q4 2014 - Q1 2015. The CTH-105 and CTH-300a studies are critical as they are the first studies of APL-130277 in Parkinson's patients. We look forward to reporting our progress."
-- Cash and cash equivalents on hand at June 30, 2014 of $20,636,044 (December 31, 2013: $2,289,046). -- Subsequent to quarter end, on July 8, 2014, the Company announced that it has been awarded a grant of USD $500,000 from the Michael J. Fox Foundation for Parkinson's Research ("MJFF"). Funds awarded by MJFF are to be used solely for the CTH-105 study and are conditioned by meeting certain milestones and deliverables. -- Net loss of $4,026,330 for the six months ended June 30, 2014 (six months ended June 30, 2013: $1,324,609). -- Net loss of $2,816,058 for the three months ended June 30, 2014 (three months ended June 30, 2013: $973,016). -- Report 78,951,816 common shares outstanding at June 30, 2014 (December 31, 2013: 38,884,009 common shares).
The following achievements were made during the first six months of 2014:
-- Cynapsus announced results for the CTH-103 clinical trial. On January 13, 2014, Cynapsus announced positive top line data of the Comparative Biostudy (CTH-103) of APL-130277. The CTH-103 study was designed as a three-dose (10mg, 15mg and 25mg) active comparator, placebo-controlled, randomized cross-over trial to examine the pharmacokinetic profile of sublingual administered APL-130277 compared to (2mg, 3mg and 4mg) subcutaneous injections of apomorphine in healthy volunteers. The 10mg and 15mg APL-130277 sublingual thin film strips were crossed over to 2mg and 3mg subcutaneous injections, with N=15 and N=14 for the two cohorts, respectively. The intent in the CTH-103 study for the third cohort was to compare the 25mg sublingual thin film strip (APL-130277) to the 4mg subcutaneous injection, but this third cohort could not be dosed due to the dose-limiting adverse events experienced with the 3mg subcutaneous injection. The 15mg APL-130277 side effects were mild-to-moderate and not dose limiting. As a result, the Company completed the CTH-104 study, a single arm, healthy volunteer pharmacokinetic study to look at the 25mg APL-130277 sublingual strip (without a crossover to the injection). -- Cynapsus announced the appointment of Nan Hutchinson to the Board of Directors. On February 13, 2014, Cynapsus announced the appointment of a new director, Nan Hutchinson, who has more than twenty-five years of pharmaceutical experience spanning all aspects of commercialization, including strategic planning, marketing, business development, sales leadership, talent identification and development. -- Cynapsus announced results for the CTH-104 clinical trial. On March 28, 2014, Cynapsus announced interim summary results of the CTH-104 study of APL-130277. Final study results were announced on April 24, 2014. The CTH-104 study was a single dose, single arm, placebo-controlled, healthy volunteer pharmacokinetic study, which was designed to examine the pharmacokinetic profile of the 25mg dose of APL-130277. In total, 13 subjects completed the study (11 active and 2 placebo). The results from the CTH-104 study in human healthy volunteers demonstrated dose proportionality of the doses tested in CTH-103 (10mg and 15mg) and CTH- 104 (25mg). In addition, the results of CTH-104 showed that the 25mg dose was sustained over an extended period of time (162 minutes) above the minimal efficacious plasma concentration of apomorphine (approximately 3ng/ml), which is believed to be a level demonstrating symptomatic relief of "off" symptoms. -- Cynapsus announced the completion of a $25 million short form prospectus financing. On April 15, 2014, Cynapsus announced that it completed a short form prospectus offering of units for maximum aggregate gross proceeds of $25 million. Cynapsus intends to use the net proceeds from the offering to complete the U.S. clinical development of APL-130277. -- Cynapsus announced no buccal mucosal irritation in U.S. FDA Registration Study of APL-130277 for Parkinson's Disease. On May 14, 2014, Cynapsus announced no irritation was observed when testing the APL-130277 sublingual apomorphine formulation in a buccal mucosal irritation model in hamsters, either macroscopically (clinician observation of oral cavity) or microscopically. The study was conducted in compliance with the Good Laboratory Practice for Nonclinical Laboratory Studies of the United States Food and Drug Administration, 21 CFR Part 58, and OECD Principles of Good Laboratory Practice. This study is also a required registration study by the FDA. Management has been aware of the possibility of buccal mucosa irritation with extended use of APL-130277. This study provides evidence that APL-130277 may provide therapeutic levels of apomorphine dosing with low or no irritation when used by Parkinson's patients multiple times per day on a daily basis. -- Cynapsus announces second grant from The Michael J. Fox Foundation for Parkinson's Research. On July 8, 2014, subsequent to the end of the second quarter, Cynapsus announced that it has been awarded a new grant of US$500,000 from the MJFF to support clinical studies to develop APL- 130277. This second MJFF grant will be used to fund the Company's CTH- 105 clinical study. CTH-105 is a pilot study in patients with Parkinson's disease who are naive to the use of apomorphine and who experience at least one daily "off" episode with a total duration of "off" in any 24-hour period of at least 2 hours. This study is planned to examine the effect of APL-130277 on relieving "off" episodes over a single day with a dose-titration used to determine dose strengths necessary for future clinical development. This study and future trials of APL-130277 will be listed on Fox Trial Finder, an online tool from MJFF matching interested research volunteers with recruiting clinical studies. -- Cynapsus announced the commencement of Phase 2 Clinical Trials in the United States. On July 17, 2014, subsequent to the end of the second quarter, Cynapsus announced that following communication from the United States Food and Drug Administration on July 16, 2014, Phase 2 clinical studies for APL-130277 will commence immediately. Specifically, clinical study CTH-105 was initiated per the proposal submitted to the FDA under the Company's Investigational New Drug (IND) application.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from "off" episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application ("NDA") expected to be submitted in 2016.
Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from 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. Based on a recent study and the results of the Corporation's Global 500 Neurologists Survey, 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.
Forward Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable securities laws. 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 its March 26, 2014, 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.
Neither the TSX Venture Exchange nor the OTCQX International has approved or disapproved of the contents of this press release.
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