The project entitled "New S-ketamine therapy for treatment-resistant depression” aims to develop a technology for a new route of ketamine administration in patients suffering from severe forms of treatment-resistant depression.
Katamine is a well-known and widely used general anaesthetic. Recently, the possibility of its use in treatment of severe episodes of treatment-resistant depression has been explored. Latest publications suggest a huge therapeutic potential of ketamine enantiomers in this indication, with ketamine administered in the form of Intravenous (IV) infusions lasting a few dozen minutes.
However, this route of administration is burdensome to patients suffering from depression, requires a continuous clinical observation of the patient, thus limiting its widespread use and, most of all, making it difficult to control adverse effects. In its new project, Celon Pharma S.A. is developing a new route of administration of the more active enantiomer of ketamine – S ketamine
Maciej Wieczorek, CEO of Celon Pharma S.A: This is another, neurological research project which we find very important and which we are able to carry out owing to the support provided by the National Centre for Research and Development. Preliminary behavioural studies confirm that the use of ketamine in this form can bring additional benefits to patients.
Jerzy Pieczykolan, Head of Preclinical Research in the Celon Pharma S.A Research and Development Centre: Our task will consist in determining the pharmacokinetic safety profile of S-ketamine administered outer venously, and verification of its safety profile for this route of administration in toxicological studies. Furthermore, we will prepare an adequate formulation of the active substance to verify the efficacy of the suggested solution in phase I and II clinical trials.
The project started in December 2015 and will be operational until end of November 2018. It will include development of a new route of administration, CMC processes, toxicology and phases I and II of clinical trials. The total value of the project is: PLN 23,386,704, of which PLN 12,670,168 is provided by the National Centre for Research and Development.
Celon Pharma S.A. is an integrated pharmaceutical company which conducts advanced research and manufactures modern drugs. It was founded in 2002 by a man with a vision, passion, interdisciplinary knowledge and experience in this line of business – Maciej Wieczorek. The primary objective of the company is the manufacturing of specialist prescription drugs which improve quality of life of patients and constitute an answer to their unmet clinical needs. Celon Pharma S.A. has two fully equipped laboratories at its disposal, dedicated to research and development (R&D) of medicinal products, both generic and innovative. Two of Celon Pharma S.A's production plants have appropriate GMP (Good Manufacturing Practice) authorisations. The main office and the laboratories are located within 30 km from the centre of Warsaw. The company currently has approx. 200 employees.