Osakidetza and the Basque bio-pharmaceutical company, Histocell (member of the Basque Health Cluster) have successfully completed the first phase of the clinical trial for the drug HC016 for the treatment of respiratory distress caused by COVID-19.
- The trial is for the cell therapy drug HC016, developed by Histocell, taking place in collaboration with the Biocruces Bizkaia Institute at the Cruces Hospital ICU.
- The purpose of the trial is to offer treatment for Acute Respiratory Distress Syndrome, the most severe complication of COVID-19 and the greatest cause of death with the disease.
- According to the Regional Health Councillor, Gotzone Sagardui: “this is another example of public-private partnership in the field of R&D&I that will feed back into the health systems and the economic and social development of the Basque Country.”
- The Basque bio-pharmaceutical firm is among the group of companies working on cell therapy around the world, with a unique, patented system.
The cell drug HC016 has been developed to treat Acute Respiratory Distress Syndrome due to COVID-19, the main cause of death with the disease. Although there is still a long way to go, the Regional Health Councillor, Gotzone Sagardui, considers this a “positive” milestone as it places the Basque Country firmly on the world stage in the use of cell therapy.
This clinical research initiative is taking place in collaboration with the Biocruces Bizkaia Institute, the Cruces Hospital ICU and the Basque bio-pharmaceutical firm Histocell. Health Councillor Gotzone Sagardui, has praised the collaborative R&D&I project between a Basque public institution and a private firm as an example of a model for generating economic and social development in the Basque Country. Histocell’s Managing Director Julio Font said, “In May we announced that we were starting this clinical trial with so much enthusiasm and, after eight months’ work, we can say we have completed Phase I and are hopeful moving forward.”
The external safety committee has confirmed that the drug is safe for use in patients as no associated adverse effects have been reported. The results have also shown signs of efficacy, and the team hopes that this will be confirmed in Phase II, which is already underway.
Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome is the most severe complication of COVID-19. Over 40% of severe hospitalisations develop this complication and around 50% of those with moderate-severe ARDS die as a result.
The purpose of this medication is to help patients to overcome this complication, reducing death rates and minimising damage to lung tissue on the mid- to long-term. The results of Phase I are a step towards achieving these goals.
The trial, which has been partially funded by the Basque Government under the COVID-19 R&D Grants, is taking place at the Intensive Care Unit of the Cruces de Osakidetza University Hospital, under the management of the Biocruces Bizkaia Health Research Institute. The lead investigator, Dr. Fermín Labayen, clinical researchers and Head of Intensive Medical Care is running the trial alongside the main clinical team including Dr. Pablo Serna, Dr. Tomás Muñoz and Dr. Victoria Boado, as well as the rest of the ICU team.
HC016 is indicated for patients in a critical condition. For the Director of Histocell, Julio Font, the successful completion of this initial stage is positive in many ways. “We had reached a major milestone, because in this case we are treating patients admitted to Intensive Care. Socially, we have the hope of reducing the death rate and complications of COVID-19. In the socio-economic sense, this is proof of the work we are doing in the Basque Country to develop new medication for COVID-19. In our sector, it places us at the leading edge worldwide.”
Histocell has been working on this cell therapy drug for Acute Respiratory Distress for over 7 years. In December 2019, the Spanish Agency for Medicines and Medical Devices (AEMPS) authorised Phases I and II of the clinical trial, which commenced in May 2020, in collaboration with the Osakidetza’s Biocruces Bizkaia Institute.
Patented cell therapy
This Basque bio-pharmaceutical firm, specialising in cell therapy is one of a small group of companies working on this kind of studies around the world. Histocell also brings a unique and differential treatment compared to other stem cell therapies.
The cell therapy drug HC016 is made with stem cells taken from adipose tissue, using in a unique process patented by Histocell, taking place at their own plant. This preparation process makes them more resistant to highly inflammatory environments such as the inside of the lungs in Acute Respiratory Distress. This means that these stem cells have greater therapeutic potential than traditional mesenchymal stem cells used in these therapies. HC016 cells have been specially design to act against acute conditions such as ARDS found in patients seriously ill with COVID-19.
New medication manufactured in the Basque Country
The Osakidetza and Histocell team has now embarked on Phase II of the clinical trial, the purpose of which is to demonstrate the drug’s efficacy. The promising results obtained so far mean that they are facing this new phase with optimism. The target is to develop and complete this phase over the course of 2021, obtaining good efficacy results.
This is a controlled, randomised and double-blind phase. It is expected that this phase will be expanded to a larger number of the hospitals taking part in the trial in order to speed up the process.
Histocell, 50 patents registered
The bio-pharmaceutical company opened in 2004 for the development of new cell therapy medicines and medical devices in the field of Regenerative Medicine. It has a division specialising in the development of stem cell medications. HC016 cells are being applied in two clinical trials, one for the treatment of moderate to severe ARDS and another for patients with acute phase traumatic spinal cord injuries in collaboration with the pharmaceutical company Ferrer.
Their main facilities are located in the Bizkaia Science and Technology Park in Derio, where they have a Cell Therapy Drug Manufacturing Unit, accredited by the Spanish Drug Agency. They also have a healthcare manufacturing plant in Larrabetzu.
Histocell’s products are backed by strong intellectual property protection, with over 50 patents registered on the world’s key markets. The company’s staff is made up of a team of 30 multi-skilled professionals.