ADELAIDE, AU, Mar 17, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today announced it will showcase its world-class immunoassay and immunobiology services for regulated bioanalysis at Bio-Europe 2021.

Dr Kurt J. Sales Agilex Biolabs' Director Immunoassay said:

"Our experienced team can develop or transfer a method for any biologic to support pre-clinical GLP or clinical studies. Our world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR. Our scientists have expertise and experience to solve the most complex immunogenicity and drug tolerance issues, often encountered in immuno-oncology studies in both an early phase and later phase setting."

Agilex Biolabs also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.

Learn more: Take a briefing with our Scientists at Bio-Europe via PartneringOne. Login Here https://informaconnect.com/bio-europe-virtual/

Or Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

Agilex Biolabs also has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Australia has led the world in keeping COVID-19 numbers down to almost zero across the country by acting swiftly to minor outbreaks.

The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC, EU and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video

Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff.

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia's leading bioanalytical laboratory, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world's most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Agilex Biolabs Media Contact:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

ADELAIDE, AU, Mar 12, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical congratulated Atossa Therapeutics on the announcement of their Phase 1 final results for the AT-301 nasal spray being developed for COVID-19.

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 Lungershausen, CEO, Avance Clinical said:

"As the CRO for this important study, we congratulate Atossa Therapeutics on these impressive safety and tolerability clinical results. Atossa Therapeutics have tapped the full scope of our CRO services including ClinicReady, our scientific and medical affairs specialist team. Australian clinical trials are recognized globally for their speed and accuracy and the fact that the clinical data is accepted by all major regulatory authorities including the FDA. Increasingly our clients are also tapping the generous 43.5% Australian Government rebate to support their clinical research."

According to Atossa Therapeutics:

Atossa Therapeutics today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa's proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.

Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild.

Atossa's assessment is that AT-301 nasal spray was safe and well tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.

"The results from this study are very encouraging and we look forward to quickly commencing the next study of AT-301," commented Steven Quay, M.D., Ph.D., Atossa's President and CEO.

Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world.

The Phase 1 study was a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects who were 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 at two different doses. Part B was a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.

The primary objectives of the study were to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives were to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.

The study was being conducted in Australia.

See full announcement here. https://tinyurl.com/6fchfvh2

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.

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:
Chris Thompson
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

ADELAIDE, AU, Feb 26, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs, and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical continues to celebrate their strategic partnership with Medidata, and the accreditation of seven Medidata inhouse experts.

The two organizations have been working together to deliver world-class clinical research services to Avance Clinical's biotech customers via the Medidata Rave Clinical Cloud™.

Avance Clinical, Chief Strategy Officer, Ben Edwards said "We look forward to many more years working with Medidata as we continue to grow the business and support the development needs of our clients."

Mr Edwin Ng, Senior Vice President, General Manager for Medidata APAC, said, "We are pleased to be supporting Avance Clinical's exceptional growth in Australia. Avance Clinical accreditation signifies the importance of Medidata's portfolio of products in ensuring the success of our partners' programs, and our continued commitment to helping our partners streamline and enhance the clinical research process."

Avance Clinical, Director Business Development Operations, Sandrien Louwaars said, "The Medidata Rave Clinical Cloud™ is a quality- and efficiency-focused unified platform that helps our biotech clients, and ensures data integrity, speed, and compliance across multisite and global studies.

"Our seven Avance Clinical accredited Medidata experts lead our efforts, and it makes a real difference for our clients having them inhouse rather than as external consultants."

Contact us about your next study. https://www.avancecro.com/eclinical-solutions/

About Avance Clinical – www.avancecro.com

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations.
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.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. eClinical solutions – 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

About Medidata – www.medidata.com

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,600+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systemes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata, The Operating System for Life Sciences™.

Medidata is a registered trademark of Medidata Solutions, Inc., a wholly-owned subsidiary of Dassault Systemes.

About Dassault Systemes – www.3ds.com

Dassault Systemes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual experience twins of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production. Dassault Systemes brings value to more than 290,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.

3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, EXALEAD, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systemes, a French "societe europeenne" (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.

Media Contact:
Chris Thompson
media@avancecro.com

Koh Shu Mei
shumei.koh@omnicomprgroup

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

BRYAN, OH, Feb 15, 2021 – (ACN Newswire) – ALG Health announced today that it received National Institute of Occupational Safety and Health (NIOSH) Surgical N95 approval for three of its Made in the U.S.A. Patriot Masks. The approvals are for the ALG Health Foldable N95 Respirator and both sizes of their Molded N95 Respirators. The surgical ratings state these products are approved and cleared for use in Healthcare settings under Food & Drug Administration (FDA)/NIOSH MOU 225-18-006 regulations. ALG Health first received NIOSH N95 ratings on all their Filtering Facepiece Respirators (FFR) in November 2020, meeting the OSHA and CDC product and manufacturing standards.

"Acquiring this next level approval for the N95 surgical rating is extremely exciting for us," said Adam Harmon, President and CEO of ALG Health. "The largest segment we work with are those in the Healthcare industry, these credentials will give them the comfort level they deserve to know they are wearing a quality mask, that will help protect them while saving lives."

The process to become (NIOSH) approved includes both a documentation and facility review to ensure that the product and the manufacturing process meet the given requirements. Not only must the product filter particulates at or above 95%, but the manufacturing and quality assurance procedures must also qualify. "The entire (NIOSH) organization has been great to work with during this time," Harmon noted, "even during this pandemic, they prioritized getting American manufacturers through the process as efficiently as possible."

Not only is ALG Health providing protection to those that wear their masks, but they are also improving those lives of the American workforce. ALG is now employing approximately 150 local workers at their two manufacturing facilities in Northwest Ohio. The company operates a 100,000 sq ft facility in Bryan, Ohio, and a smaller 10,000 sq ft facility in Defiance, Ohio.

ALG Health is also in the process of expanding its distribution network. "We are looking for reputable distributors in the Healthcare, Government, and industrial/commercial segments," said Brian Feeney, VP of Sales and Marketing. "The demand for our high-quality American made products has been outstanding and we expect with the new surgical rating it will increase greatly. Finding the right distributor partners is paramount, as it is the ALG Health brand they will be representing."

About NIOSH
The Occupational Safety and Health Act of 1970 external icon established (NIOSH) as a research agency focused on the study of worker safety and health, and empowering employers and workers to create safe and healthy workplaces. (NIOSH) is part of the U.S. Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. It has the mandate to assure "every man and woman in the Nation safe and healthful working conditions and to preserve our human resources." (NIOSH) has more than 1,300 employees from a diverse set of fields including epidemiology, medicine, nursing, industrial hygiene, safety, psychology, chemistry, statistics, economics, and many branches of engineering. Visit https://www.osha.gov.

About ALG Health
ALG Health is a 2020 division of the parent company, Axis LED Group, a manufacturer of commercial and governmental LED lighting. Using its manufacturing expertise, ALG Health produces personal protective equipment, including disposable surgical masks and medical-grade respirators. Having previously received (NIOSH) approval and now the (NIOSH) Surgical rating, the company is concentrating on servicing the medical community, first responders, military, manufacturing and humanitarian efforts. Visit https://www.alg-health.com.

Media Contact:
Brian C. Feeney
ALG Health
+1-877-798-6275
info@alg-health.com


Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com