Accellena | Expertise & Cases

ACCELLENA | through evidence to the stars

ACCELLENA
Research & Development
2022

"In ACCELLENA, we have found a reliable partner in the development of new pharmacologically active substances discovered in our laboratories. In almost three years of joint development, we have almost completed the preclinical development stage and are close to the first in human study initiation."

Prof. Raul Gainetdinov

Professor, Head of Laboratory of Neuroscience and Molecular Pharmacology at St. Petersburg State University

"Over the years of cooperation with ACCELLENA, we have participated in dozens of joint clinical research projects. Prompt resolution of issues, professionalism and involvement are the main features of our colleagues from ACCELLENA."

Dr. Viktoria Dedkova

Deputy head of Scientific research center “Eco-Safety”

"Our ethics committee has been providing support for clinical trials conducted by ACCELLENA for more than five years. Consistent quality of the documents provided, effective communication in solving emerging issues - all this contributes to the quality and ethics of the research conducted by the company."

Mrs. Marina Zakharova

Executive secretary at Independent Ethics Committee “BioEthics”

Early phases expertise

To date, the company has conducted 15 phase I trials and 6 phase I/II trials of small molecules, biologics and medical devices. Alltogether, more than 1800 subjects were included in these early studies.

Back in 2019, a Middle East Respiratory Syndrome (MERS) vaccine study was launched, laying the foundation for the success of two first-in-human clinical trials in 2020 of one of the world’s first Sputnik V vaccines against novel coronavirus infection (SARS-CoV-2) in very difficult conditions of the anti-epidemic measures.

Since 2015, the company has participated in 28 clinical bioequivalence (BE) studies, including studies with replicative design, pharmacodynamic endpoints, fasting or fed conditions. In total, more than 1,000 participants took part in these studies.

Early phases cases

A representative selection of relevant cases

F-I-H, vaccine trial

WORLD FIRST SARS-CoV-2 VACCINE FIRST-IN-HUMAN STUDIES

Participants: 43+43 (healthy COVID-19 naïve subjects)
Average accrual rate: all in one week
Status: completed
Highlights: strict pandemic restrictions and subjects’ isolation.

The first two studies (two different forms of the Sputnik V vaccine) in humans were organized by Accellena in the midst of the COVID-19 pandemic. A features of these studies were extremely limited time resources and strict anti-epidemic measures in force at that time. The need for isolation and a strict anti-epidemic regime for subjects before the start of the study itself, with minimization of the risks of possible outbreaks of the disease among isolated subjects, has also become a significant difficulty. These obstacles required a major effort in the organization of the study, which eventually led to the success of both studies.

Comparative PK study

NASAL SPRAY AND SOLID ORAL DOSAGE FORMS COMPARATIVE PK STUDY

Participants: 35 (healthy subjects)
Average accrual rate: all in one week
Status: completed
Highlights: PK comparison of two different dosage forms with challenging dosing procedure

A comparative PK study, relatively simple in design, but challenging in terms of dosing procedure. This study compared IMP in tablet form to nasal spray form. The difficulty was the standardisation of the spray dosing procedure in the research centre, including its technical support. Solving these issues made it possible to successfully conduct the study, and register the product.

F-I-H in ICU conditions

MEDICAL DEVICE FOR cDNA RESORPTION IN PATIENTS WITH SEPTIC SHOCK

Participants: 20 (patients with septic shock)
Average accrual rate: 4+ per month
Status: completed
Highlights: Very serious condition and ICU environment

First-in-human study of the medical device for resorption of circulating DNA (cDNA) from the systemic circulation in patients with septic shock for prevention of acute kidney injury. A key feature of the study was its conduct in difficult conditions in intensive care units (ICU) in patients with septic shock on the background of COVID-19.

MERS vaccine

MIDDLE EAST RESPIRATORY SYNDROME (MERS) ADENOVIRUS VACCINE

Participants: 291 (healthy subjects)
Average accrual rate: 60+ per month
Status: completed
Highlights: Enrolment of healthy subjects by manageable cohorts and fast biosamples' logistics

Relatively large, placebo-controlled dose escalation phase I/II study of MERS (coronavirus) vaccine. A significant part of subjects have been studied for the parameters of the cellular response by various methods, including flow cytometry. This circumstance imposed special time requirements for the transportation of ambient blood samples from a research centre in one city to a laboratory in another. The solution lied not only in the plane of organising the controlled transportation of samples, but also in organising the work of the centre for subject management.

F-I-H, monoclonal antybody

SARS-CoV-2 MONOCLONAL ANTIBODY FIRST-IN-HUMAN STUDY

Participants: 101 (healthy COVID-19 naïve subjects)
Average accrual rate: 30+ per month
Status: ongoing
Highlights: strict pandemic restrictions and subjects’ isolation.

Cohort single dose escalation study of monoclonal antibody in COVID-19 naïve healthy volunteers. The challenge in conducting this study was to find and enroll naive subjects in the second year of the COVID-19 pandemic, nevertheless ACCELLENA succeded in maintaining a high recruitment rate.

Late phases expertise

Accellena's first clinical trial in 2015 was a proof-of-concept trial of an antitumor drug conducted in the USA, Europe and the CIS. By 2018, the company conducted more than 15 clinical trials, and by mid-2022, we took part in more than 70 clinical trial projects.

More than 25 of these were late phase clinical trials at various stages, including 15 completed by today.

The company has acquired the greatest experience in late phase research in the following areas: research on vaccines, infectious diseases, oncology, neurology, gastroenterology and surgery.

The company's experience is not limited to clinical trials. Since 2015, Accellena has been involved in major case-control epidemiological studies in the field of infectious diseases. We has successfully conducted a study of medical nutrition, cellular biomedical products (CAR-T therapy), and are actively involved in the study of the safety and efficacy of medical devices, both diagnostic and used for treatment, including life-threatening conditions in CPR units.

Late phases cases

A representative selection of relevant cases

International study

ORPHAN ONCOLOGY TRIAL

Participants: 58 (orphan disease)
Average accrual rate: 5 per month
Countries and sites: 5 /21
Status: passed to another indication
Highlights: orphan disease, different regions and investigative sites

Our first study ever and the first study for an orphan indication involving research centres in the US, Canada and Europe. This is a relatively small phase 2 proof-of-concept study with extensive use of biological markers and state-of-the-art technology. ACCELLENA have gone all the way from Scientific Boards and US FDA pre-IND meetings to interacting with specialised professional communities in the US, such as the Gynaecology Oncology Group (GOG) to successfully launch and execute the project.

The largest phase III trial for cUTI

ANTIMICROBIAL RESISTANCE TRIAL

Participants: 777 (hospitalised cUTI patients)
Average accrual rate: 20+ per month
Sites: 30+
Status: ongoing
Highlights: Large study with challenging biosamples logistic and central standardised assessments

The largest phase III clinical trial for hospitalised patients with complicated urinary tract infection (cUTI) investigating the efficacy of treatment designed to overcome antibiotic resistance for common nosocomial pathogens. The study includes 777 participants at over 30 research centres. A feature of this study, in addition to the relatively large number of patients, is the complex logistics of biological samples, central evaluation and standardisation of laboratory methods.

Rapid pace of recruitment

LARGE ANTI-FLU VACCINE PEDIATRIC TRIAL

Participants: 1660 (paediatric 6m+ population)
Average accrual rate: 500+ per month
Status: completed
Highlights: Large vaccine paediatric study with risk based approach and central statistical monitoring

The influenza vaccine study, one of many other large vaccine studies. In this project, we included 1660 children aged 6 months and over into the study in the shortest possible time. The main difficulty of this study was the need for operational verification and processing of the received data, the rate of growth of which was rapid due to the equally rapid pace of recruitment. We have implemented risk based monitoring solutions using statistical monitoring methods to maintain a high pace of the entire study preserving the quality.

Stress-induced insomnia study

INSOMNIA TRIAL WITH CENTAL POLYSOMNOGRAPHY

Participants: 212 (stress-induced insomnia)
Average accrual rate: 20+ per month
Status: completed
Highlights: Central polysomnography reading and assessment as a “bottle neck” and successful patients management

Stress-induced insomnia study involving over 200 maladjusted patients. This study included polysomnography at a specialised research centre using a central reading and evaluation procedure. Since this is a lengthy procedure, the main challenge was to coordinate the enrolment of subjects in all participating centres, taking into account the availability of the polysomnography facility, as well as to standardise the assessment of a rather subjective phenomenon of sleep.

RWD/RWE expertise

To date, the company has conducted three research projects using real clinical practice data.

The first of these was the study of the use of hormone therapy in the treatment of breast cancer. Despite the relatively small number of participants, much attention was paid to the duration of follow-up of health status, as well as the qualitative assessment of response to treatment according to RECIST.

The other two projects were large case-control epidemiological studies to study the preventive efficacy of an antiviral agent and an influenza vaccine in large (several thousand people) production teams.

Within the framework of these projects, issues related to the comprehensive collection of data on incidence in the entire study population were successfully resolved.

RWD/RWE cases

A representative selection of relevant cases

Long follow-up with RECIST assessment

OBSERVATIONAL STUDY TO INVESTIGATE HORMON THERAPY OF BREAST CANCER IN REAL CLINICAL PRACTICE

Participants: 29 women with breast cancer on hormonal therapy
Accrual rate: 3 per month
Status: completed
Highlights: patient retention strategy and central RECIST assessment in settings of observational study

A remarkable study of the use of hormonal therapy in patients with breast cancer and study of the effectiveness of combined treatment when prescribing drugs that affect the hormone receptor status in real practice. A feature of this study was a long follow-up period for these patients, in many cases more than a year, as well as a centralized assessment of the response by RECIST. Within the framework of this study, interesting scientific data were obtained, which may become the beginning of a new direction in the treatment of tumors with a low level of hormone receptors, or that have lost sensitivity to hormone therapy already during treatment.

Study backed by pharmaeconomic analysis

CASE-CONTROL STUDY TO INVESTIAGATE ANTI-VIRAL DRUG FOR FLU AND COLD PREVENTION IN AUTOMOBILE PLANT

Participants: 2150 healthy subjects
Average accrual rate: all in one month
Status: completed
Highlights: classical epidemiological “Case-control” study with more than 2000 participants and pharmacoeconomic analysis

A large epidemiological case-control study involving all workers in an automobile plant. The prophylactic use of the antiviral agent significantly reduced the risk of acute respiratory infections and influenza by more than two times and led to significant savings in the company's funds, which was found out in the course of a pharmacoeconomic analysis.

Interesting features of this study were the design of the study, the participation of more than 2000 employees of the plant and the wide involvement of the enterprise's health centers in the process.

Study backed by pharmaeconomic analysis

CASE-CONTROL STUDY TO INVESTIAGATE ANTI-FLU VACCINE FOR FLU PREVENTION IN AUTOMOBILE PLANT

Participants: 2450 healthy subjects
Average accrual rate: all in two months
Status: completed
Highlights: classical epidemiological “case-control” vaccine study with more than 2400 participants and economic analysis

Large case-control epidemiological study involving all workers in a manufacturing plant. The use of the vaccine significantly reduced the risk of influenza by almost three times and led to significant cost savings for the enterprise, which was found out during the cost-benefit (cost-benefit analysis) analysis.

The interesting features of this study were the design of the study, the participation of more than 2400 plant employees, and the pharmacoeconomic analysis.

ACCELLENA headquarters:

Tel.: +7 (812) 337 58 66
Fax: +7 (812) 337 58 08
info@accellena.com

88, lit.A., Sredniy pr. V.O.,
St. Petersburg, Russia,
199106

Kesklinna linnaosa, Vesivärava
tn 50-201, Estonia, Tallinn,
10152