ENGLISH
|
JAPANESE
|
CONNECT WITH US:
Home
About
Contact
Log in
*
Home
Press release
Jul 22, 2020 14:00 JST
Source:
Avance Clinical
Avance Clinical Contracted for Atossa Therapeutics AT-301 Nasal Spray Clinical Study, Atossa's Second COVID-19 Therapeutic Development Program
ADELAIDE, AUS, Jul 22, 2020 - (ACN Newswire) - The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been contracted to conduct a clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, to be administered by nasal spray. Avance has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.
Yvonne Lungerhausen, CEO, Avance Clinical said:
"Avance Clinical is very pleased to be working with Atossa Therapeutics again on their second COVID-19 Therapeutic Development Program. Atossa is a valued long-term client that clearly understands the excellence in clinical research available in Australia, and the many benefits of conducting studies in the region."
According to Atossa Therapeutics:
AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2.
The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.
"Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators," commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. "Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a 'vaccine-like mechanism' to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel," concluded Dr. Quay.
An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter. Adequate and well-controlled studies to demonstrate safety and efficacy must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.
About Atossa Therapeutics
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19. For more information, please visit www.atossatherapeutics.com.
See full announcement here
https://tinyurl.com/y46rcp33
About Avance Clinical
Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups. Visit
http://www.avancecro.com
for more information.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic - speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5-6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons
Media Contact:
media@avancecro.com
Chris Thompson
Source: Avance Clinical
Sectors: Healthcare & Pharm
Copyright ©2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
Latest Release
DOCOMO and NTT Com Jointly Demonstrate Practicality of DOCOMO's New Multi-platform Cloud-rendering Technology
Jul 26, 2024 17:05 JST
TANAKA Precious Metals Provided Award Items and Ceremony Souvenirs for the International Friendly Matches of the Japan Men's National Blind Football Team at the "DAICEL Blind Football Japan Cup 2024 in Osaka" on July 7
Jul 26, 2024 03:00 JST
Eisai and EcoNaviSta Enter into Business Alliance Agreement Aimed at Building a Dementia Ecosystem and Commence Collaboration
Jul 25, 2024 10:30 JST
Hitachi Awarded Largest Contract in Singapore to Supply 450 Lifts at HDB Blocks
Jul 24, 2024 16:27 JST
Hitachi to Announce Capital Reorganization of Air Conditioning Joint Venture
Jul 24, 2024 15:02 JST
Eisai to Present Dual-Acting Lecanemab Three-Year Efficacy and Safety Data and Discuss Long-Term Outcomes of Continued Treatment at the Alzheimer's Association International Conference 2024
Jul 23, 2024 20:23 JST
Toyota Material Handling Japan and Fujitsu launch Japan's first service for evaluating forklift safety in the cloud using AI
Jul 23, 2024 11:26 JST
AEON and CJPT working to resolve logistics industry issues and achieve carbon neutrality at AEON Fukuoka XD
Jul 22, 2024 13:52 JST
Rovanpera and Ogier score another TOYOTA GAZOO Racing one-two
Jul 22, 2024 12:30 JST
Team HRC with Japan Post Wins 45th Suzuka 8 Hours Endurance Road Race
Jul 22, 2024 11:33 JST
Honda to Hold its Official e-Motorsports Event, "Honda Racing eMS 2024"
Jul 19, 2024 20:04 JST
MHI America Acquires Three Utility-Scale Solar Power Projects in Pennsylvania, Advancing the Company's Energy Transition Strategy
Jul 19, 2024 19:04 JST
JCB and Worldline unveil a new whitepaper offering European merchants invaluable insights into facilitating seamless payments for international consumers
Jul 19, 2024 12:00 JST
Fujitsu Chosen to Help Solving Social Issues Caused by Fake News
Jul 19, 2024 11:30 JST
Champion REIT holds first 'ESG Week'
Jul 18, 2024 20:14 JST
Lexus LBX Adds a New High Performance Variant, the LBX "MORIZO RR"
Jul 18, 2024 17:25 JST
VitalLife and Bumrungrad International Hospital in Thailand Launch NEC's FonesVisuas Test: First Major Deployment Outside Japan, Revolutionizing Disease Risk Prediction
Jul 18, 2024 15:34 JST
Fujitsu publishes CHRO Roundtable Report 2024, summarizing the challenges and implications of the implementation of data-driven human capital management
Jul 18, 2024 10:44 JST
Fujitsu-sponsored professional golfer Ayaka Furue victorious in the Amundi Evian Championship
Jul 16, 2024 23:26 JST
Neste and Mitsubishi Corporation agree on strategic partnership to develop supply chains for renewable chemicals and plastics
Jul 16, 2024 18:36 JST
More Latest Release >>
Related Release
Avance Clinical Appoints Asia Regional Director as Part of Global Expansion Program
July 23 2024 16:00 JST
New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Can Deliver 30% Savings, Halve Timelines and Cut Risks for Biotechs
June 04 2024 22:00 JST
Avance Clinical Expands Specialist CNS, Cardiometabolic, and Rare Diseases CRO Services in Europe with Julius Clinical
May 31 2024 16:00 JST
Avance Clinical Expands Further into APAC with New Clinical Operations in South Korea
May 08 2024 09:00 JST
Avance Clinical Showcases Clinical Excellence at World Orphan Drug Conference in Boston, April 23-25
April 19 2024 16:00 JST
Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study
March 28 2024 14:42 JST
Avance Clinical CEO Talks with SCRIP about US Biotech Sector "Green Shoots" and a New CRO Report
February 28 2024 08:00 JST
Latest Analysis Reveals 65% of US Biotechs Struggle to Identify Suitable CRO Partner
January 12 2024 16:00 JST
Avance Clinical Invited to Brief 45 Korean Biotechs on Their GlobalReady Drug Development Pathway from Korea and Australia to the US
October 19 2023 09:00 JST
Avance Clinical at ASCO & BIO 2023: Early Phase Oncology Trials Increasingly Elaborate and Demand More Patients
May 30 2023 10:00 JST
More Press release >>