Media and News Releases
Upcoming and Past Events
New Drug Application to the U.S. FDA for Parkinson’s Treatment
19 Nov 2020
The regulatory department at Amarex Clinical Research, LLC, an NSF International company, recently submitted a new drug application (NDA) on behalf of its client. The Amarex team also wrote a substantial portion of the NDA and did the publishing.
U.S. FDA Grants Fast Track Designation to Amarex Client PRG S&T Inc.
22 Oct 2020
Amarex Clinical Research, LLC, an NSF International company announced that the U.S. FDA granted Fast Track designation to Amarex’s client PRG S&T Inc. for PRG’s drug Progerinin, being tested as a treatment for Hutchinson-Gilford Progeria Syndrome (HGPS) and Werner Syndrome (WS).
Amytrx Enrolling Clinical Trial of AMTX-100 in Patients with Atopic Dermatitis
08 Oct 2020
Amarex client, Amytrx Therapeutics (“Amytrx”), recently initiated clinical testing of their anti-inflammatory therapeutic product AMTX-100 for dermatological diseases and conditions with the enrollment of patients in a first-in-man Phase 1/2b study for treatment of mild to moderate atopic dermatitis.
Copy Of -Amarex to Support AIM ImmunoTech in Regulatory Filings for Exciting Pancreatic Cancer Treatment under Development
22 Sep 2020
Amarex Clinical Research, LLC (Amarex) client AIM ImmunoTech Inc. (NYSE American: AIM) today announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus Medical Center in the Netherlands.
Now Enrolling for a Phase IIb Trial Treating Patients with HPV-Induced CIN2/3
21 Sep 2020
Amarex Clinical Research, LLC, an NSF International company announces its client, Frantz Viral Therapeutics, LLC, is now enrolling for their Phase IIb pivotal clinical trial of Artesunate Vaginal Inserts for the treatment of biopsy-proven HPV-associated cervical intraepithelial neoplasia 2/3 (CIN2/3) in adult female patients.
Amarex Receives SMP Letter from TFDA for an Oncology Drug Clinical Trial Treating Pancreatic Cancer
10 Sep 2020
Amarex Clinical Research, LLC, an NSF International company announces today that earlier this week they received a study may proceed (SMP) letter from the Taiwan Food & Drug Administration (TFDA) to conduct the first in human clinical trial of RP-72 in Taiwan. RP-72 is a 72 amino acid propriety recombinant protein antagonist for the CXCR1 and CXCR2 receptors of interleukin-8, a drug that treats pancreatic cancer. In early 2020, Amarex also received a SMP letter from the U.S. FDA for RP-72 to treat pancreatic cancer.
Phase 3 Trial for Patients with Severe-to-Critical COVID-19 Symptoms Reaches Enrollment Halfway Point
26 Aug 2020
Amarex Clinical Research, LLC, an NSF International company, announced today their client’s Phase 3 clinical trial for patients with severe-to-critical COVID-19 symptoms has reached the patient enrollment halfway point. Amarex’s team has managed the trial and will conduct the interim analysis.
Phase 2 Mild-to-Moderate COVID-19 Study Results for PRO 140
21 Aug 2020
Amarex Clinical Research, LLC, an NSF International company announced the completion of a Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating efficacy and safety of PRO 140 (leronlimab) in patients with documented COVID-19 symptoms.
Amarex Highlighted in NSF International’s Latest Health Sciences Journal
06 Aug 2020
The just released Issue 47 of NSF International’s Health Science Journal features contributions by Amarex Clinical Research, LLC: 1) a white paper on Safety Risk Management; 2) an interview with visiting trainee from the Korean Ministry of Food and Drug Safety (MFDS); and 3) an overview of Amarex’s work on clinical products dealing with COVID-19 disease.
Congratulations to our client Akili Interactive on their recent approval!
25 Jun 2020
Learn more about this product approval here.
Amarex Client Now Enrolling Patients for a Blood Filtration Device Study Treating COVID-19 Patients Experiencing Septic Shock
02 Jun 2020
In April, Amarex Clinical Research, LLC, an NSF International company, achieved rapid, supplemental Investigation Device Exemption (IDE) approval from the U.S. FDA, on behalf of its client, to treat COVID-19 patients experiencing septic shock under an already underway Phase III clinical trial of a blood filtration device.
Amarex Co-Authors Paper on Emergency Use Treatment of Leronlimab for COVID-19
28 May 2020
In mid-March, Amarex worked with client CytoDyn to prepare, submit, and achieve FDA approval for emergency use of CytoDyn’s drug leronlimab as a treatment for severe cases of COVID-19. Since then, over 50 patients in a New York hospital have been treated with leronlimab. Initial results appear to show that leronlimab restores immune homeostasis, reduces plasma viral load, and reverses hyperimmune activation and inflammation in critically ill COVID-19 patients.
Webinar Recording Available for Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design
On October 27, Dr. Kush Dhody, Senior Vice President of Clinical Operations, conducted the webinar Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design. The recording of this webinar is now available.
Cancer treatments are fulfilling the promises of personalized medicine. One aspect is the use of biomarkers detectable in blood such as circulating tumor cells. This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints; and umbrella or basket designs that allow multiple drugs to be tested against a cancer in a single trial, or a single drug to be tested against multiple cancer types in a single trial. Dr. Dhody also discusses the challenges of interpreting traditional survival analysis methods in this era of personalized cancer immunotherapies.
View the webinar recording on our YouTube channel.
Webinar Recording: Amarex in the Fight Against COVID-19
Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, LLC, an NSF International company presented a webinar highlighting Amarex’s COVID-19 work. Dr. Kazempour also discusses clinical trial regulatory activities around the globe, non-COVID-19 clinical trial activities, and emergency use authorizations (EUAs) for IVDs (including but not exclusive to COVID-19 trials).
View the webinar recording here.
Since March, Amarex has helped numerous companies with COVID-19 clinical product development (including device, diagnostic, drug, biologic, and vaccine products). Additionally, Amarex’s Regulatory department has executed applications and requests for compassionate use, emergency use, EUA, Clinical Trial Agreement, preIND meeting, eIND, fast track designation, and expanded access in the U.S., UK, Europe, and Asia.
TFDA Seminar Recordings Available: FDA Approval Process for Digital Health Devices and EUA’s
On June 22, 2020, Dr. Kazem Kazempour, President & CEO, Amarex Taiwan, LLC and Dr. Chia-Hua Maggie Ho, COO of Amarex Taiwan, LLC gave a seminar to the Taiwan Food and Drug Administration (TFDA) titled U.S. FDA Approval Process for Digital Health Devices and Emergency Use Authorizations. Video recordings from the seminar are available for viewing. Topic summaries include:
Software as medical device (SaMD) is broadly defined as software intented to be used for one or more medical purposes, without being part of a hardware medical device. SaMD products vary in use and complexity, including image-reading software that runs on a smartphone to advanced artificial intelligence (AI) such as machine learning algorithms. This course introduces regulatory strategy and clinical evaluation required for market approval of software and AI-related medical products. Current international medical software regulation and risk management of AI medical products, and clinical evaluation of software as medical device are discussed.
During the COVID-19 pandemic, the FDA can use its emergency use authorization (EUA) authority to allow the use of unappoved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent COVID-19 when certain criteria are met, including that there are no adequate, approved, and available alternatives. This training course explains FDA general recommendations and proceudres applicable to the authorization of the emergency use of COVID-19 diagnostic devices.
2020 Bio Innovation Conference | Oct. 5-6
Amarex Clinical Research, LLC, an NSF International company, will exhibit and present at the 2020 Bio Innovation Conference hosted by the Maryland Technology Council and held October 5-6.
The conference anticipates participation by 300 bioscience industry leaders involved in clinical product development and business success. Speakers will share experiences and information about best practices for clinical product business start-ups. Significant participation by international companies is expected. The two-day conference will be conducted online and includes presentations, panel discussions, live Q&A, and a one-on-one partnering program.
Amarex President & CEO, Dr. Kazem Kazempour, will present at Session C: Entrepreneurship Track, ‘Business Resiliency for the Unexpected and Expected’
Business resiliency implies ability to handle unexpected, difficult situations: lack of funding, a failed clinical trial, a surprise FDA audit, loss of a key employee, a lawsuit, stagnant sales, etc.; but it also means preparedness for achieving expected goals: licensing a product, raising funds, advancing the product, selling the product or business, etc. In this session a panel of entrepreneurs will share advice on business resiliency based on their business experiences.
Register for this conference at https://www.marylandlifesciences.com/conference/.
KoNECT-MOHW-MFDS International Conference Virtual | Sep 9-11
Amarex Clinical Research, LLC, an NSF International company, is pleased to announce exhibiting at 2020 Korea National Enterprise for Clinical Trials (KoNECT) Ministry of Health and Welfare (MOHW) Ministry of Food and Drug Safety (MFDS) International Conference Virtual, held September 09-11. This year, the conference will be live-streamed online and offers presentations and workshops on new technologies and approaches to clinical trials in Asia, with a special focus on advanced regenerative medicine, biopharmaceuticals, and medical devices.
Register for this conference (and sign up for virtual partnering with us) at https://www.konectintconference.org/.
Visit us at virtual booth #2: http://www.kic-exhibition.or.kr/contents/company02.php.
Video Recording: Clinical Trials for Advanced Therapies
On 24 July 2020, Amarex Taiwan, LLC President & CEO, Dr. Kazem Kazempour, gave a keynote address at BioAsia-Taiwan 2020 titled Clinical Trials for Advanced Therapies.
Dr. Kazempour discusses significant differences in trial design often needed for advanced therapy products (e.g., antibody or nucleic acid products), compared to designs for traditional, small molecule pharmaceutical products. Dr. Kazempour highlights special challenges for these trials, including sample size and power calculations to provide the optimal chance to demonstrate efficacy. Beyond design strategies, Dr. Kazempour reviews special expedited development support programs available from the U.S. FDA.
View the full recording here.
Webinar Recording Available: Trial Design in General & Adaptive Trials in Particular
The full recording of our complimentary webinar, reviewing clinical trial design, is available here.
This webinar is presented by Amarex President & CEO, Dr. Kazem Kazempour. He addresses aspects of before study and after study clinical trial design. Physicians focus groups, KOL thoughts, selecting endpoints, IP management and distribution, site selection and patient recruitment are discussed. This webinar focuses specifically on the advantages and disadvantages of adapting a clinical trial.
Webinar Recording Available: Emergency Market Authorization of COVID-19 IVDs
The full recording of our complimentary webinar, reviewing insights into the Emergency Market Authorization of COVID-19 IVDs, is available on YouTube.
This webinar covers emergency authorization applications for the E.U., the U.S., Asia, Australia and the World Health Organization.
Learn from industry experts:
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Robyn Meurant, Executive Director at NSF International. Before joining NSF, Robyn acted both as a professional officer and an advisor to the WHO and assisted with the development of the EUL for IVDs.
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Chia-hua Maggie Ho, D. Phil., COO of Amarex Clinical Research, LLC, an NSF International Company. Dr. Ho specializes in APAC regulatory submission, clinical operations, business development and client services for the Pan-Pacific region.
View the full webinar here.
Contact our experts, Robyn Murant, at rmeurant@nsf.org, and Chia-hua Maggie Ho, at maggieh@amarextw.com, or get in touch with our Business Development team.
Medical Device Training & Education Courses
Sign up for an NSF International medical device course and learn from experts at your own pace. Course offerings are available in auditing, premarket regulatory, quality system regulation and eLearning.
View the medical device training and education course offerings brochure.
To register for a course, or for more information, visit visit nsfmedicaldevices.trainingfolks.com/store or contact healthsciences@nsf.org.
