NovalGen is committed to developing innovative treatments.
We operate with integrity and carefully test our new treatments in well-designed clinical trials to ensure safety and efficacy. We acknowledge the importance of collaboration with healthcare professionals, hospitals, clinics and, of course, the people living with the diseases we aim to treat. Each person plays an invaluable role in making these innovative treatments available.
We conduct all our clinical trials in compliance with international regulations and guidelines, including good clinical practices (GCP), and gain approval from national and regional regulatory authorities, as well as local ethics committees and institutional review boards. We always protect the legal rights, integrity and dignity of all clinical trial participants.
We have high ethical standards in our clinical studies and:
- We carry out studies only in well-regulated locations, in countries where the medical standards and Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) are adequate and suitably regulated.
- We obtain all approvals, both scientific and ethical, in accordance with international regulations and guidelines.
- We ensure patients understand the opportunities and risks of the study.
- Investigators provide balanced study information and obtain free, informed consent from participants.
- We process all personal information in accordance with data protection legislation.
- We continuously monitor study participants to ensure any emerging issues are identified. We report adverse events in accordance with current legislation.
- We pay only fair honoraria to investigators and research teams for study-related activities.
- We make study outcomes public, whatever the results, in accordance with international reporting standards.
- We ensure clinical trial participants can easily access information about their rights and have a grievance process.
- We conduct our clinical trials in accordance with the Declaration of Helsinki and the ICH GCP guidelines, the Code of Federal Regulation (US), the CIOMS and the EU Clinical Trials Directive, the Nuremberg Code and UNESCO’s Universal Declaration on Bioethics and Human Rights.
Our first clinical study with NVG-111 study will include patients with blood cancer, either chronic lymphocytic leukaemia or mantle cell lymphoma. The trial has two parts, the first part tests the safety of the drug at different dose levels, and the second part tests how well it works in treating these diseases. Patients will receive 3 cycles of NVG-111 by continuous intravenous infusion, each cycle consists of 21 days treatment followed by 7 days break. An additional 3 cycles may be given depending on the response seen.
For full clinical study text about NVG-111 please go to clinicaltrials.gov identifier NCT04763083 or directly via the link below: