Connect with us

CureApp Announces Results from World’s First Randomized Control Study for Digital Therapeutic Smoking Cessation App

Published

on

Reading Time: 3 minutes

Results Confirm the Efficacy of CureApp’s Nicotine Dependence
Treatment Application

TOKYO–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/ClinicalTrial?src=hash” target=”_blank”gt;#ClinicalTriallt;/agt;–Results from the world’s first randomized control study to examine
digital therapeutic smoking cessation programs were presented on May 20th
at the American Thoracic Society International Conference. The findings
demonstrate that CureApp’s nicotine dependence treatment app resulted in
an improvement in continuous abstinence rate (CAR) compared to a control
group over multiple time points.

Kohta Satake, M.D., M.B.A., M.P.H., Chief Executive Officer of CureApp,
Inc.
and a respiratory specialized physician says, “Healthcare
professionals are challenged to help patients fight against the
psychological nicotine addiction alone between clinical visits.
CureApp’s digital therapeutics approach is a breakthrough in bridging
the gap between clinical visits providing daily support to the patients.
We are striving for regulatory and reimbursement approval to deliver the
solution as soon as possible.”

The CureApp solution delivers information and educational material
through an app that is conveniently on the patient’s smartphone,
together with a Carbon Monoxide (CO) monitor for tracking their
progress, and a web interface for physicians. CureApp’s system is the
first such program to undergo the rigorous testing of Phase III clinical
trials. With this confirmation of its efficacy, CureApp’s goal is to use
this data to obtain regulatory approval and health insurance coverage in
Japan and to expand globally in multiple countries including the United
States.

Nicotine dependence

Nicotine dependence is a type of drug dependence; its intensity has been
reported to be comparable to that of heroin and cocaine*1.
Smoking is the Number 1 leading cause of preventable death in Japan*2
and the US*3.

The Clinical Trial

CureApp’s Phase III clinical trial in Japan was completed in December
2018, and the results were presented at the America Thoracic Society
International Conference, ATS 2019 by Dr. Hiroki Tateno, Division of
Pulmonary Medicine, Department of Medicine, Keio University, School of
Medicine.

The continuous abstinence rate (CAR)* at 9 to 24 weeks, the primary
endpoint to verify the efficacy of the CureApp Smoking Cessation, was
statistically significantly higher in the trial treatment group than the
control group, demonstrating that the CureApp Smoking Cessation
contributed to continuous smoking abstinence.

*Continuous abstinence rates at 9 to 24 weeks: Rates of patients who
continuously abstained from smoking at 9 to 24 weeks after the start of
smoking cessation treatment
.

The clinical trial was a multicenter, randomized, prospective, two-group
comparative study of the efficacy and safety of the CureApp Smoking
Cessation in combination with the standard smoking cessation treatment
program in patients with nicotine dependence who visited a smoking
cessation clinic. In this clinical trial, the CureApp Smoking Cessation
(smartphone application for patients, portable CO checker for patients,
and web-based application for physicians) or control device (the control
group application) was used for 24 weeks in addition to the standard
smoking cessation program.

Of the 584 patients who participated in this trial, 285 patients were
assigned to the treatment group using the application for nicotine
dependence treatment, 287 patients were assigned to the control group
using the control application. Total of 572 patient data was used for
analysis. The main evaluation item is “Continuous Abstinence Rate (CAR)
at Week 9-24”.

Efficacy

The CAR at 9 to 24 weeks, the primary endpoint, was 63.9% (182/285
subjects) in the trial treatment group and 50.5% (145/287) in the
control group. The CAR was higher by 13.4% in the trial treatment group,
showing a statistically significant difference (95% confidence interval,
1.239-2.424; P = 0.001), with an odds ratio of 1.73. The result
demonstrates that the CureApp Smoking Cessation contributed to
continuous smoking abstinence.

*1 Source: Kinen no Igaku (Medicine of Smoking Cessation), Japan
Medical Association
https://www.med.or.jp/forest/kinen/medical/
(Japanese)

*2 Source: Adult Mortality Attributable to Preventable Risk Factors for
Noncommunicable Diseases and Injuries in Japan in 2007, the Ministry of
Health, Labour and Welfare
https://www.mhlw.go.jp/topics/tobacco/houkoku/dl/120329_1.pdf
(Japanese)

*3 Source: Health Effects of Cigarette Smoking, CDC
https://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/index.htm

About CureApp

CureApp, Inc., a MedTech venture company, engages in research and
development to create and market medical programs and devices for
disease treatment with advanced software technology and medical
evidence. Its pioneering work in digital therapeutics will bring new
solutions for a variety of conditions, including nicotine addiction,
diabetes, and hypertension amongst others.

Currently, CureApp is jointly developing a nicotine dependence treatment
solution with the Division of Pulmonary Medicine, Keio University,
School of Medicine (clinical trial completed), a non-alcoholic
steatohepatitis (NASH) treatment solution with the University of Tokyo
Hospital (clinical trial in progress), and a hypertension treatment
solution with Cardiovascular Medicine, Jichi Medical University
(clinical trial in progress).

By leveraging the knowledge and findings accumulated in the development
of these treatment applications for medical institutions, CureApp
provides mobile health programs for private corporations and health
insurance associations, including the “ascure Smoking Cessation Program”
and “ascure STEPS Lifestyle Habit Improvement Program.” CureApp plans to
expand these and other digital therapeutic solutions from Japan to the
global market. For more information visit, https://cureapp.co.jp/en/.

Contacts

For US media
Joy Scott, CEO, Scott
Public Relations
E-mail: Joy@scottpublicrelations.com
Phone:
818.610.0270

For media from other countries
Nanako
Daime, Public Relations Manager, CureApp, Inc.
E-mail: nanako.daime@cureapp.jp

Cannabis

Willow Biosciences Reports Third Quarter 2019 Results and Provides Operations Update

Published

on

 

Willow Biosciences Inc. (“Willow” or the “Company“) (CSE: WLLW, OTCQB: CANSF) has released its financial and operating results for the three and nine months ended September 30, 2019.

“Over the past few months, Willow has continued to advance its business strategy and achieved several important milestones,” said Trevor Peters, Willow’s President and Chief Executive Officer. “We have made meaningful progress on advancing our yeast strain performance and fully expect to meet our projected timing of scale-up development in the first half of 2020. In addition, we have completed the commissioning of our three labs and expanded our team of highly skilled scientists, preparing us for future development.  As the market for CBD and other cannabinoids continues to develop, Willow is positioned as a leader in delivering ultra-pure, pharmaceutical grade cannabinoids, at a highly competitive cost for the consumer packaged goods and pharmaceutical industries.”

Selected financial and operational information is outlined below and should be read in conjunction with Willow’s unaudited condensed consolidated interim financial statements (“Financial Statements”) and related management’s discussion and analysis (“MD&A”) which are available on SEDAR at www.sedar.com or on the Willow’s website at www.willowbio.com.

Highlights for the Quarter:

  • Willow’s science team successfully increased cannabinoid production by 25-fold and identified hundreds of beneficial genetic changes that are expected to provide additional increases.
  • Willow ended the quarter with strong liquidity, including approximately $24.0 million of cash on hand at September 30, 2019.
  • Willow continued to build out our three labs in Calgary, AlbertaBurnaby, British Columbia and Mountain View, California, spending $3.2 million in capex in the quarter ($6.4 million year to date as of September 30th). With the bulk of our capital spending to set up our labs behind us, Willow continues to focus on advancing our yeast strain to produce ultra-pure, pharmaceutical grade cannabidiol (CBD).
  • In the quarter we moved into our new facility in Calgary, Alberta located in the Life Sciences Innovation Hub at the University Research Park. The 4,000 square foot secure facility employs cutting-edge bioassay capabilities, liquid handling robots, and analytical instrumentation, and leverages access to the University of Calgary’s plant cultivation resources and growth chambers.
  • Willow continues to progress its intellectual property portfolio and expects to file five new U.S. provisional patent applications and one Patent Cooperation Treaty “PCT” conversion (which will convert an existing provisional patent application to a U.S. PCT application), all prior to the end of 2019.
  • Subsequent to the end of the quarter, the Company received its DEA Controlled Substances Registration Certificate for our Mountain View, California facility, which allows the Company to develop yeast strains which produce CBD.
  • On November 5, 2019, the Company commenced trading on the OTCQB® Venture Market under the ticker “CANSF”.
  • Willow’s directors and officers remain committed to the long-term success of the Company and since July 1, 2019, certain officers and board members of Willow have purchased approximately 1.5 million common shares and warrants of Willow in the market for aggregate proceeds of approximately $840,000.

Operational Update

During the past quarter, we have expanded our research and development team to 33 technical staff, including 21 Ph.D. level scientists, across our three sites. Our multidisciplinary team consists of plant scientists, strain engineers, analytical chemists and fermentation process engineers.  The team’s focus has now shifted from expanding its technical capabilities to program execution and operational excellence.  Our plant sciences team in Canada continues to advance its understanding of cannabinoid accumulation in C. sativa along with translation of these results in our yeast production host.  These results are further complemented by our high-throughput strain engineering capabilities in our San Francisco Bay Area labs to expand upon beneficial genetic diversity and further optimize our yeast strain toward commercial targets.  As a result of these combined efforts, we have increased cannabinoid production by 25-fold and identified hundreds of beneficial genetic changes that will provide additional increases.  These improved strains are now undergoing evaluation in fermentation tanks at our development partner’s facilities.  At our current trajectory, we anticipate delivering a strain for scale up development starting in the first half of 2020.

Financial Update

Willow ended the quarter in a strong financial position, with approximately $23.2 million in working capital and $24.0 million of cash on hand.

The Corporation’s financial results are summarized as follows:

Three months ended
September 30

Nine months ended
September 30

2019

2018

2019

2018

Balance sheet ($000’s):

Cash and cash equivalents

24,042

804

24,042

804

Total assets

38,624

1,038

38,624

1,038

Shareholder’s equity

24,727

975

24,727

975

Weighted average shares outstanding

Basic and diluted (000’s)

78,634

56,521

69,657

53,585

Year to date 2019 has been transformative for the Company. The transactions Willow has completed have had a significant impact on the comparability of the Company’s period over period results. See the Financial Statements and MD&A for further details.

Outlook

Willow will continue to focus on developing and refining our yeast-based strains that biosynthesize CBD, optimizing our production levels and improving the performance of our processes. We expect to reach a scalable production level in the first half of 2020, triggering the initiation of Noramco, Inc.’s efforts to ramp up production, file regulatory submissions and develop marketing and distribution plans. The scaling up of production to commercial levels is expected to take 12 to 18 months, followed by regulatory approval for the manufacturing process and customer sampling during 2021, and first bulk commercial sales anticipated in late 2021 or early 2022.

Following our successful financings, Willow is well positioned to fund our operations to commercialization.

Willow continues to evaluate strategic relationships with various entities in the consumer packaged goods and pharmaceutical industries. These partnerships will look to define our market participation and potentially gain entry into new global markets.

 

SOURCE Willow Biosciences Inc.

Continue Reading

Cannabis

OPSEU gives thumbs down to Ford’s attempt to fix cannabis debacle

Published

on

Photo source: netnewsledger.com

 

The Ford government’s latest reset of its disastrous decision to privatize cannabis sales is bound to make an already bad situation worse, says OPSEU President Warren (Smokey) Thomas.

“What will it take for the government to understand that cannabis retail stores need to be operated by trained professionals?” asked Thomas.

Thomas can’t believe the Ford government is set to move to an “open allocation” system for issuing retail cannabis licenses as early as January that could result in over 1,000 outlets across Ontario.

“I can’t figure out why the Conservatives think it makes sense to continue on with this privatization disaster,” said Thomas.  “We need a Responsible Plan, the kind of plan the previous government had that would have put cannabis sales in the hands of the LCBO.

“Polls have shown us that Ontarians are 11 times more likely to trust the LCBO than private retailers when it comes to keeping cannabis out of kids’ hands,” Thomas added.

“This is a matter of public safety. LCBO stores have trained professionals who have the training and experience to handle sales of controlled substances.”

Over a year ago when the discussion around cannabis retail stores began, the Ford government made a number of promises – promises they are now breaking, says Thomas.

“They promised a tightly regulated system. What does this new plan involve? It involves flooding the market. How is that responsible? The second promise was to keep our kids safe. This doesn’t keep our kids safe.”

“Our members who operate LCBO stores are experts in responsible sales,” he adds. “They keep our kids and our communities safe because they are trained and qualified. They take social responsibility seriously.”

It’s time for Ford to give up trying to find solutions for a problem that doesn’t exist, says OPSEU First Vice President/Treasurer, Eduardo (Eddy) Almeida.

“The solution has been there in front of them all along,” says Almeida.  “How many failed attempts and half-baked ideas are they going to try?”

“First Mr. Ford hits us with a crazy lottery scheme that resulted in only a handful of stores operated by people as random as the process that selected them and now he just wants to open this up as a free-for-all? We need a clear and thoughtful plan, and the LCBO is the solution.”

SOURCE Ontario Public Service Employees Union (OPSEU)

Continue Reading

Cannabis

CannTrust Provides Default Status Report

Published

on

 

CannTrust Holdings Inc. (“CannTrust” or the “Company”, TSX: TRST, NYSE: CTST) today is providing a status update in accordance with its obligations under the alternative information guidelines set out in National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”), which require the Company to provide bi-weekly updates until such time as the Company is current with its filing obligations under Canadian securities laws. As previously announced, the Company is subject to a management cease trade order (“MCTO”) issued by the Ontario Securities Commission. The MCTO prohibits the directors and executive officers of the Company from trading in or acquiring securities of the Company until two full business days after the Company files an interim financial report for the three and six month periods ended June 30, 2019, an interim management’s discussion and analysis for the corresponding period and certifications of interim filings. The MCTO does not affect the ability of investors who are not insiders to trade in the securities of the Company.

Timing of Financial Results

Although the Company is continuing to make progress in working with its independent auditor in connection with its restated audited financial statements for the year ended December 31, 2018, its restated interim financial statements for the first quarter of 2019, and its interim financial statements for the second and third quarters of 2019, together with the related management’s discussion and analysis for the corresponding periods, such financial statements are unlikely to be completed and filed before the end of the calendar year.

The Company advises that: (i) other than as disclosed above, there have been no material changes to the information contained in the Company’s August 16, 2019 news release, August 29, 2019 news release, September 12, 2019 news release, September 26, 2019 news release, October 10, 2019 news release, October 24, 2019 news release, and November 7, 2019 news release; (ii) it intends to continue to comply with the alternative information guidelines of NP 12-203; and (iii) except as previously disclosed, there are no subsequent specified defaults (actual or anticipated) within the meaning of NP 12-203.

Forward-Looking Statements

This press release contains “forward-looking information” within the meaning of Canadian Securities laws and “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and other applicable United States safe harbor laws, and such statements are based upon CannTrust’s current internal expectations, estimates, projections, assumptions and beliefs and views of future events. Forward-looking information and forward-looking statements can be identified by the use of forward-looking terminology such as “believes”, “expect”, “likely”, “may”, “will”, “should”, “intend”, “anticipate”, “potential”, “proposed”, “estimate” and other similar words, including negative and grammatical variations thereof, or statements that certain events or conditions “may”, “would” or “will” happen, or by discussions of strategy.

The forward-looking information and statements in this news release include statements relating to the corrective actions being taken by the Company, and Health Canada’s pending determinations. Forward-looking information and statements necessarily involve known and unknown risks, including, without limitation: actions taken in respect of the Company’s products by its customers and regulators; results of Health Canada’s investigation, including orders and compliance measures required by Health Canada and their impact on the operations, inventory, assets and financial condition of the Company; the Company’s implementation of remediation plans and related actions; regulatory approval; risks associated with general economic conditions; adverse industry events; loss of markets; future legislative and regulatory developments in Canadathe United States and elsewhere; the cannabis industry in Canada generally; and, the ability of CannTrust to implement its business strategies.

Any forward-looking information and statements speak only as of the date on which they are made, and, except as required by law, CannTrust does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. New factors emerge from time to time, and it is not possible for CannTrust to predict all such factors. When considering these forward-looking information and statements, readers should keep in mind the risk factors and other cautionary statements in CannTrust’s Annual Information Form dated March 28, 2019 (the “AIF”) and filed with the applicable Canadian securities regulatory authorities on SEDAR at www.sedar.com and filed as an exhibit CannTrust’s Form 40-F annual report under the United States Securities Exchange Act of 1934, as amended, with the United States Securities and Exchange Commission on EDGAR at www.sec.gov. The risk factors and other factors noted in the AIF could cause actual events or results to differ materially from those described in any forward-looking information or statements.

The TSX and NYSE do not accept responsibility for the adequacy or accuracy of this release.

SOURCE CannTrust Holdings Inc.

Continue Reading

Trending Online

Grassnews is a news publishing website which digests / hand picks the latest news about the cannabis industry, and serves them to you daily.

Contact us: pressroom@grassnews.net

© Grassnews.net 2019 - part of PICANTE Media. All rights reserved. Registered in Romania under Proshirt SRL, Company number: 2134306, EU VAT ID: RO21343605. Office address: Blvd. 1 Decembrie 1918 nr.5, Targu Mures, Romania