Jul 31, 2018 | DGI Clinical, News
DGI Clinical has launched a new app, SymptomGuide Dementia, that allows caregivers to track and manage symptoms of Alzheimer’s disease.
The app allows caregivers to learn about dementia, including Alzheimer’s disease, and provides management strategies for dealing with symptoms.
Caregivers can choose those symptoms most important to them and share progress with family and clinicians. The app is functional on iOS devices and available free on the app store.
“Over two decades of research and conversation with people living with dementia and their caregivers has formed the foundation of SymptomGuide Dementia,” Dr. Kenneth Rockwood, President and Chief Scientific Officer of the company said in a statement.
Rockwood, a geriatrician and Alzheimer’s disease researcher, said the app is designed to give caregivers comprehensive, current information about dementia, its symptoms, stages, treatments as well as an easy-to-use method of capturing an individual’s information and experience in a manner that’s meaningful for the caregiver.
“Our hope is that the information tracked with SymptomGuideTM Dementia will be used for discussion with family members and for shared decision-making with clinicians.”
The app was launched at the Alzheimer’s Association International Conference in Chicago, an event attended by over 5,600 clinicians, researchers and industry scientists, the statement said.
In Canada, the Alzheimer’s Society reports almost 600,000 Canadians are living with dementia. In the US, the Alzheimer’s Association indicates that 5.7 million Americans are currently living with Alzheimer’s disease, a number projected to reach nearly 14 million by 2050.
Over 16 million Americans currently provide care for people living with Alzheimer’s disease and other forms of dementia. Most are unpaid family members who suffer an emotional, financial, and physical toll as a result of caring for people living with Alzheimer’s disease. the statement said.
DGI has a suite of proprietary electronic Clinical Outcome Assessment (eCOA) tools for licensed use by sponsors in drug development. The company’s products focus mostly on digital tools for diseases of the central nervous system such as dementia, Parkinson disease, and schizophrenia but also include applications for other chronic, complex diseases such as hemophilia]]>
Jul 30, 2018 | ABK Biomedical, News
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ABK Biomedical Inc., a company dedicated to the research, development and commercialization of innovative embolic therapies, has announced the appointment of Michael J. Mangano as president and CEO.
Mangano will be responsible for leading global business activities, including the rapid development, regulatory approval and commercialization of ABK’s unique medical device technologies.
Mangano most recently served as president and CEO of ReShape Medical, a US venture-backed company focused on obesity where he increased organizational value and played a lead role in orchestrating the sale of the company to EnteroMedics in October 2017.
Prior to ReShape, Mangano was president of the Americas for Sirtex Medical, a leading publicly traded Australian biomedical company, where he grew the business nearly five-fold from $30 million to more than $140 million while building a team of 17 to more than 130 employees in six years. His leadership resulted in a dramatic increase in the company’s valuation, leading to the recently announced acquisition in progress of Sirtex Medical by CDH Investments for $1.4 billion USD.
Prior to Sirtex, Mangano spent 15 years with Boston Scientific in numerous senior management roles, including overseas assignments in Japan and Australia.
Mangano was recently appointed to the board of directors of Ellex Medical Lasers Limited (ASX:ELX), a global leader in medical devices for the diagnosis and treatment of eye diseases.
ABK Biomedical chair Dr. Aaron Berez commented, “Mike is an accomplished leader with a history of global success in building dynamic teams, leading organizational change, creating and shaping strategies and executing programs – all directly increasing shareholder value. His vast experience in sales and marketing management, product development, strategic planning, international business, M&A, project management and business model development will be invaluable as he takes the reins at ABK and leads the company into the next phase of our evolution.”
Mangano will continue to serve on the ABK board of directors.
“I am excited to join the team at ABK, which has outstanding experience in the medical device industry. The talent at ABK, coupled with an innovative technology platform and pipeline, provide a strong foundation and solid prospects for our future growth and success,” said Mangano. “I especially look forward to working with the interventional radiology and oncology communities to develop and market novel technologies that will help patients and physicians, and want to thank the founders and the board of ABK for their support.”
Dr. Bob Abraham, co-founder and former CEO, is a practicing interventional radiologist and will remain with the company as chief medical officer. He will continue to play a key role in product development and the clinical evolution of ABK’s key technology platforms.
About ABK Biomedical Inc.
ABK Biomedical is organized to research, develop and commercialize breakthrough medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors. Specifically, ABK holds intellectual property in the focus area of inorganic polymer microspheres, targeted at the growing field of embolotherapy within the interventional radiology/interventional oncology medical disciplines. The company possesses advanced intellectual capital and its own R&D and manufacturing facilities for developing and commercializing unique, breakthrough embolotherapy products.
For more information, please contact:
Elizabeth Romero
Fleishman Hillard
919.457.0749
[email protected]
Gary Donofrio
ABK Biomedical Inc.
617.513.9575
[email protected]
Halifax, Nova Scotia, July 30, 2018]]>
Jul 30, 2018 | Appili Therapeutics, News
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New Antibiotic Formulation Designed to Treat Parasitic and Anaerobic Bacterial Infections; Appili Will Use Study Data as Basis for NDA Filing
HALIFAX, Nova Scotia, July 30, 2018 – Appili Therapeutics Inc. (the “Company” or “Appili”) announced today positive top-line results of a pivotal relative bioavailability study evaluating pharmacokinetics, safety, and palatability of ATI-1501 in healthy, normal adults. Data from this study will be used to file a New Drug Application (NDA) with the US Food & Drug Administration (FDA) for ATI-1501 in early 2019. ATI-1501 is a proprietary, taste-masked oral suspension formulation of the antibiotic metronidazole, which is broadly prescribed to treat parasitic and anaerobic bacterial infections that heavily burden the elderly.
The clinical study results announced today showed that a single 500 mg dose of ATI-1501 achieved equivalent systemic drug levels to a 500 mg metronidazole tablet under fasted and fed conditions. ATI-1501 was well tolerated and safety observations for ATI-1501 were consistent with the known safety profile of metronidazole.
“Appili Therapeutics set out to address an unmet medical need – namely to provide an alternative antibiotic solution for patients with difficulty swallowing. Our clinical data demonstrate that ATI-1501 has an acceptable safety profile while being more palatable than metronidazole tablets for a vulnerable patient population,” said Jamie Doran, MSc, DABT, ERT
,Vice President of Drug Development for Appili. “As we move towards a submission to the FDA for market approval, we anticipate that ATI-1501 will soon be available to healthcare providers and caregivers as an excellent alternate treatment option for those with serious infections requiring treatment with metronidazole.”
In many countries, including the US and Canada, oral metronidazole is only available in solid forms. Patients with difficulty swallowing the oral tablet require pharmacists, the patients themselves or caregivers to crush the drug and add it to food prior to patients ingesting it. This process increases risk for dosing error and amplifies the pronounced bitter taste of metronidazole that can negatively impact patients’ ability to comply with their full treatment regimen. The bitter taste of metronidazole is so pronounced that it is listed as an adverse event on the drug label. ATI-1501 has been designed to offer patients with difficulty swallowing the drug a more palatable, easy-to-take liquid suspension alternative.
About the Bioavailability Study
The primary objective of the randomized, open-label, single-dose, two-sequence, cross-over clinical study was to assess the relative bioavailability of ATI-1501 compared to the reference product Flagyl® (solid metronidazole tablets) under fasted and fed conditions. Clinicians performed the study under an Investigational New Drug application (IND) and a Clinical Trial Application (CTA) approved, respectively, by the US Food and Drug Administration and Health Canada in 2017. A total of 44 healthy adults aged 18 to 63 years completed the study.
A planned subset of participants was also asked to evaluate the taste properties and relative preference for ATI-1501 compared to metronidazole crushed in applesauce, which is the current standard of care for elderly and pediatric patients with difficulty swallowing. Palatability measures were assessed using the 9-point hedonic scale, the most widely recognized and used scale to measure taste preference and selection in the food industry. A total of 25 participants participated in this palatability and preference component, ranging from 18 to 63 years of age. ATI-1501 exhibited meaningful and statistically significant improvements across all palatability measures (taste, bitterness, smell, texture) compared to crushed tablets with a corresponding reduction in bitterness scores and a strong preference for ATI-1501 over the current standard of care.
Based on these findings, Appili expects to submit complete study results for publication in a peer-reviewed medical journal.
“We are currently pursuing commercial manufacturing activities to support an NDA filing in the first quarter of 2019,” said Appili CEO Kevin Sullivan, MBA. “In addition, we are actively engaged in commercialization and licensing activities to maximize patient access to ATI-1501 in US and global markets.”
About Appili Therapeutics
Appili Therapeutics, Inc., was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this challenging disease space. Balancing near-to-market product candidates with higher-risk but potentially transformative early-stage programs, Appili’s growing pipeline includes assets being developed by Appili as well as an active licensing program. ATI-1501 employs Appili’s proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of pediatric and elderly patients with difficulty swallowing. ATI-1503 is a drug discovery program aimed at generating negamycin analogue candidates, a novel class of antibiotics with broad-spectrum activity against Gram-negative bacteria. Via an in-licensing program, Appili acquired the rights to ATI-1701, a vaccine for tularemia, removing risk from a weaponized bioterrorism pathogen. Headquartered in Halifax, Nova Scotia, with offices in Mississauga, Ontario, Appili is pursuing worldwide opportunities in collaboration with science and industry commercial partners, governments and government agencies. For more information, visit
www.AppiliTherapeutics.com.
