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Proof of concept trials

PROOF OF CONCEPT TRIALS

proof of concept trials

ARENSIA delivers high degree of scientific and logistical expertise for Phase I/Ib/IIa and PROOF OF CONCEPT patient studies.

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PHASE I SPECIAL POPULATIONS

phase i special populations

ARENSIA offers exceptional fast recruitment rates for renal and hepatic impaired patients.

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REGULATORY PROCESS

regulatory process

ARENSIA has the know-how to successfully manage the regulatory process in various Eastern European countries.

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ARENSIA NEWSLETTER - 1st HALF of 2019

HOME · NEWS · ARENSIA NEWSLETTER - 1ST HALF OF 2019
Dear Colleagues, Partners and Collaborators,

It has been a tremendous 1st half of 2019 with some really exciting developments at ARENSIA.  
Our continued dedication to complex early phase Ib/IIa studies has amounted to over 50 trials across our units since the beginning of 2019. Below are some of our most recent study achievements:
  • Phase Ib study in Moderate to Severe Pulmonary Hypertension with a small molecule of sGC being run in our Moldova unit. This study involves a Right Heart Catheterization (RHC) and Functional Respiratory Image (FRI). We have successfully implemented an approach to have these assessments performed as part of the trial procedures with minimal impact to the patients.
  • First-in-patients HIV study with a NRTTI with a novel mechanism of action has been very well received by our medical teams due to its unique nature that distinguishes it from similar NRTI’s. This study is being conducted in our Romanian unit.
  • TOP Recruiters in our Ukraine unit for a Phase I study in patients with Moderate to Severe Atopic Dermatitis investigating a IgG1 monoclonal antibody. We ensured the patients where comfortable with the required multiple biopsies.
  • Recruitment leaders in a complex study for a HER2/NEU peptide vaccine in HER2 overexpressing patients with metastatic or advanced carcinoma of the stomach or gastroesophageal junction in our Georgia unit. The first study data were presented by Dr. M. Maglakelidze at ESMO GI conference in July.
We have also made some considerable corporate milestones during this year:
  • As a result of an exceptional start and achievements at our Ukraine unit, in mid-July this year ARENSIA officially opened a 2nd clinical research unit in the downtown area of Kiev. This important expansion allows us to meet the increasing demand for early phase studies in Ukraine and further enriches our catchment area for a broader range of patients across a myriad of therapeutic areas.
  • In June we completed our 1st FDA inspection at the ARENSIA units in Moldova and Georgia. The inspection was cited due to our completion of a BE study in breast cancer where our units enrolled 22 patients in 17 weeks. The data was included as a basis for the registrational dossier. The outcome of the inspection was very successful with no 483 form being issued. Our QA and operational teams made sure that all the requirements where completed at the full satisfaction of the sponsor. This study’s outcome will lead to the drug approval in the US
  • ARENSIA successfully hosted 5 self-sponsored workshops dedicated to “Advancing Optimization in Early Clinical Development”. Over 150 senior delegates from pharmaceutical and biotech companies attended our events in Boston, Princeton, San Francisco, San Diego, London and Copenhagen to openly share their operational and regulatory challenges. There were some really vivid discussions covering a range of topics on the future developments in the early phase space. There are still some workshops coming soon in Basel, Switzerland (17th October), Boston (20th November) and Raleigh-Durham (21st November). We really encourage you to attend one of upcoming workshops, please visit www.arensia-em/conferences to learn more about our events.

ARENSIA’s dedication in pioneering innovating approaches in performing safe, fast, quality complex early phase patient trials continue to help our sponsors achieve their research targets and importantly change patient’s lives daily.

Recent Recruitment Metrics from a range of Therapeutic Areas:

INDICATION

STUDY PHASE/DESIGN

RECRUITMENT ACHIEVEMENTS

LOCATION

Pulmonary Arterial Hypertension
(moderate to severe)

Phase I - ambulatory visits

11 patients in 8 weeks

1 unit: Moldova

Hepatic impairment (severe)

Phase I - 6 days hospitalization

5 patients in 32 weeks

1 unit: Romania

Metastatic Gastric Cancer
(HER2 overexpression)

Phase Ib - ambulatory visits

6 patients in 14 weeks

2 units: Moldova & Georgia

Chronic HBV
HBV-DNA Positive

Phase I - 4 days hospitalization

6 patients in 1 week

1 unit: Moldova

Atopic Dermatitis
(moderate to severe)

Phase I - ambulatory visits

14 subjects in 22 weeks

1 unit: Ukraine

Ulcerative Colitis (moderate to severe)

Phase I - 9 days hospitalization

11 patients in 10 weeks

2 units: Moldova & Georgia

HIV

Phase I - 2 days hospitalization

17 patients in 18 weeks

1 unit: Romania

09.09.2019