Histocell has successfully completed phase I of the clinical trial of the cell therapy drug HC016, which has been developed to treat Acute Respiratory Distress caused by covid-19 , the leading cause of mortality of the disease. Although there is still a long way to go, the Basque Regional Minister of Health Gotzone Sagardui has assessed this step as “positive” as it places the Basque Country on the world stage in the use of cell therapies.
This clinical research initiative is being developed in collaboration with the Biocruces Bizkaia Institute, the Cruces Hospital ICU and the Basque biopharmaceutical company Histocell. The Basque Minister of Health Gotzone Sagardui has highlighted the collaboration in the field of R&D&I between public institutions and Basque companies as an example of a model that generates economic and social development for the Basque Country.
Julio Font, Histocell’s CEO, stated that “in May we announced that we were starting the clinical trial with great enthusiasm and, after eight months of work, we can say that we have completed phase I with great hope”.
The external safety committee has confirmed the safety of the drug in the treatment of patients, which has been carried out without adverse effects associated to it. In addition, the results have shown signs of efficacy, so the team hopes to confirm it in phase II, which has already started.
Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome (ARDS) is the most serious complication caused by COVID-19. More than 40% of seriously ill hospitalised patients develop it, and around
50% with moderate-severe ARDS die from it.
The objective of this medication is to help patients overcome this complication, reduce the mortality rate and minimise the damage caused to the lung tissue in the medium-long term. The results of phase I go one step further in achieving these objectives.
The trial, which has been partially funded by the Basque Government within the framework of the COVID-19 R&D grants, is being carried out in the Intensive Care Unit of the Cruces Hospital, managed by the Biocruces Health Research Institute, in Bilbao. The principal researcher, Dr. Fermín Labayen, Chief of Intensive Medicine, leads the trial together with the main clinical team that includes Dr. Pablo Serna, Dr. Tomás Muñoz and Dr. Victoria Boado, in addition to the rest of the ICU team.
The HC016 cell therapy drug is indicated for patients in critical condition. For Julio Font, the news of the completion of this first phase has positive readings in many ways. We are facing an important milestone, because in this case we are treating patients who enter the ICU. For the society, it gives us hope to minimise the mortality and complications of COVID-19. An in our sector, it places us at the global forefront.
Histocell has been developing this cell therapy drug for Acute Respiratory Distress for more than 7 years. In December 2019, the Spanish Agency for Medicines and Health Products (AEMPS) authorised phases I and II of the clinical trial, which started in May 2020, in collaboration with Biocruces.
Patented cell therapy
Histocell, specialised in advanced therapies for regenerative medicine, is among the small group of companies that are conducting this type of study worldwide. In addition, Histocell provides a differential and unique treatment compared to other stem cell therapies.
HC016 cell therapy drug is based on stem cells obtained from adipose tissue that have been prepared with a unique process patented by Histocell and carried out in Histocell’s facilities. This preparation makes them more resilient in highly inflammatory environments, such as that which occurs in the lung in Acute Respiratory Distress. Therefore, these stem cells have a greater therapeutic potential than traditional mesenchymal cells used in cell therapy. HC016 cells have been specially designed to work in acute diseases such as ARDS, which occurs in severe covid-19 patients.
New medicament manufactured in the Basque Country
Histocell has already entered phase II of the clinical trial, to demonstrate the efficacy of the drug. The promising results make the company face the new phase with optimism. The objective is to develop and finish phase II throughout 2021, obtaining efficacy results.
Phase II is a controlled, randomised and double blind. It is expected to expand the number of hospitals participating in this phase to speed up the process.
Histocell, more than 50 registered patents
Histocell was established in 2004 with the mission of developing new medical devices and cell Therapy drugs in the field of regenerative medicine. Histocell has two main production facilities. HC016 cells are being applied in two clinical trials, in the treatment of moderate-severe ARDS and in patients with acute-phase traumatic spinal cord injury together with Ferrer Pharmaceuticals.
Its main facilities are located in the Science and Technology Park of Bizkaia, in Derio, where it has a Cell Therapy Medicines Manufacturing Unit, accredited by the Spanish Medicines Agency, and it also has another medical device manufacturing plant in Larrabetzu.
Histocell’s products are backed by strong intellectual protection, with more than 50 patents registered in major world markets. It is staffed by a team of 30 multidisciplinary professionals.