Media and News Releases
Upcoming and Past Events
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.
Amarex Submits a CTA to Belgium Health Authorities for a COVID-19 Clinical Trial
22 May 2020
Yesterday, Amarex Clinical Research, LLC, an NSF International company, on behalf of a client, submitted a Clinical Trial Application (CTA) to Belgium health authorities. The CTA is for a therapeutic product to treat serious side-effects of the COVID-19 disease in a special patient population.
Amarex Accelerated COVID-19 Product Authorization/Approval Services
19 May 2020
Amarex Clinical Research, LLC, an NSF International company, is an expert at streamlining regulatory and clinical trial testing services for product development and FDA approval.
We are applying additional resources to rush timelines for all COVID-19 product projects.
Free Webinar: Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design | October 27, 2020 | 11:00 AM EDT
Amarex Clinical Research, LLC, an NSF International company’s Senior Vice President of Clinical Operations, Dr. Kush Dhody, will conduct a free webinar on Tuesday, October 27, 2020 at 11:00 a.m. EDT entitled Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design.
Cancer treatments, particularly, are fulfilling the promises of personalized medicine, especially using genetic biomarkers in cancer cells. This webinar reviews several newer clinical trial strategies such as combining adaptive trial designs with innovative endpoints; and umbrella and basket designs that allow one cancer type with multiple genetic biomarkers to be tested against multiple drugs in a single trial, or multiple cancer types with a common biomarker tested against a single drug in a single trial. Dr. Dhody will also discuss the challenges of interpreting traditional survival analysis methods in this era of personalized cancer immunotherapies.
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.
Webinar: Upgrading the FDA Adverse Event Reporting System (FAERS) Based on International Council for Harmonisation (ICH) E2B (R3) Standards | April 7, 2020 11:00 AM EDT
Amarex Senior Vice President of Safety and Pharmacovigilance, Shide Badri, MD, is conducting a free webinar on Tuesday, April 7, 2020 at 11:00 AM EDT entitled Upgrading the FDA Adverse Event Report System (FAERS) Based on International Council for Harmonisation (ICH) E2B (R3) Standards.
This webinar addresses the US FDA’s plan to modernize electronic submission standards for drug, biological and drug/biologic-led combination products for the premarket and post market safety surveillance programs. The webinar summarizes upgrades to electronic submission of Individual Case Safety Reports (ICRs) in the FDA Adverse Event Reporting System (FAERS) using ICH E2B(R3) standards that are disclosed to the public, FAERSII’s implementation timeline, benefits and impacts on stakeholders and industry.
For more information or to register for this webinar, visit http://www.nsf.org/training-education/training-entry/webinar-upgrading-the-fda-adverse-event-reporting-system-faers
March Training Activities: Transitioning from MDD to MDR
In collaboration with NSF PROSYSTEM GmbH, Amarex is hosting two free training sessions covering key changes to effect clinical investigations when transitioning from the medical devices directive (93/42/EEC) (MDD) to the medical devices regulation (EU 2017/745) (MDR).
On Tuesday, March 17, 2020 at 10:00 AM EST Amarex President & CEO, Dr. Kazem Kazempour, and PROSYSTEM Managing Consultant, Clinical Affairs, Sandra Bugler, will present a free webinar reviewing regulatory requirements for clinical studies and clinical investigations.
To register for this webinar, visit https://www.nsf.org/training-education/training-entry/webinar-clinical-investigations-transitioning-from-mdd-to-mdr
On Tuesday, March 31, 2020, from 9:00 AM – 5:00 PM, in Hamburg, Germany, Amarex and PROSYSTEM will host a free seminar addressing the current regulatory status and the relevant requirements for the planning, execution and completion of a clinical investigation, with a special focus on the Regulation (EU) 2017/745.
For more information or to register, visit https://www.nsf-prosystem.com/veranstaltungen/clinical-investigation-of-medical-devices/
