08/H1306/147

Leeds (East) Research Ethics Committee

Synairgen Research Ltd

Respiratory Tissue Bank

Respiratory Tissue Bank

Permission to publish contact details not yet received

Permission to publish contact details not yet received

TISSUE SAMPLE COLLECTION
The following samples will be collected:
1) Blood
2) Sputum
3) Bronchial samples including lavage, bronchial brushings and biopsies
4) Nasal lavage

The blood and sputum samples are used immediately or frozen at -80 degrees centigrade and stored. The biopsies are stored in GMA (at -20 degrees centigrade) and paraformaldehyde (at 4 degrees centigrade). Fibroblasts are stored in liquid nitrogen until they are required. The time that these samples can be kept for before they deteriorate is not known, however our previous experience shows that they can all be kept for at least 5 years with no obvious signs of deterioration.

It is anticipated that samples will be collected from approximately 100 volunteers a year. Samples will be sent frozen to other researchers or cooled to the storage temperatures. Approximately 50% of samples will be initially stored. The other 50% will be used immediately. Around 10% of the stored samples will be distributed to third parties.

DATA COLLECTION
The following data will be collected and stored for linking with the tissue samples.
Date of birth, age, gender, racial category, vital signs (BP, pulse, respirations), weight, height, BMI, date of diagnosis, family history of asthma, current asthma symptoms and frequency, current asthma medication, other medication, other significant medical/surgical conditions, results of the physical examination (including cardiovascular system, respiratory, ENT, lymph glands, gastrointestinal/genitourinary, neurology), menstrual history, skin allergy test results, spirometry results (included percent predicted values), methacholine challenge results.

The data will be collected by direct contact with the subjects and by performing the respiratory tests and procedures. The medical history will be completed by questioning the subjects. If the details are unclear and the subject agrees their medical notes may be consulted for clarification. This will not be done routinely. For subjects in the COPD group they will be asked to complete a respiratory questionnaire.

The data will be recorded in the case report form and also in the subjects medical notes. The Synairgen team will have access to the case report form which will only contain linked annonymous data. To aid communication some of the data will be stored on a spread sheet on the Synairgen server. This will be annonymous data and will include, age, gender, medications and lung function tests. The classification code and the subject code will be used for points of reference. The data is held on a secure server.

None

Synairgen is a University Spin Out company located within the University of Southampton. Synairgen has collected samples since 2004 to support its research in asthma and chronic obstructive pulmonary disease (COPD). Synairgen uses the samples to identify differences between diseased and non-diseased individuals’ samples. These differences represent potential new drug targets. Once a new target has been identified then new drug products can be developed for the benefit of patients.
By way of example, cells from the samples have been grown by scientists in cell culture systems to make miniature models of the lining of the lung. These cell models have been exposed to the things that are known to aggravate asthma and COPD such as viruses or cigarette smoke. In the case of viruses a deficiency of an antiviral protein called interferon beta was discovered, interferon beta is being developed for use in the clinic (currently in Phase I clinical safety trials). Furthermore the models were very important tools in demonstrating that the drug could correct the infection problem, and help understand how interferon would work in the lungs.
Synairgen cannot complete all of the work in house, and collaborates closely with other groups such as the University of Southampton, other academic groups, and industry. Synairgen would process and store the samples and other parties would analyse the samples at an appropriate stage using their technology.
The existence of the bank is publicised in the respiratory research arena, mainly by way of presentations and in collaboration discussions. The investment community would also be informed about this core technology platform. In addition Synairgen will use ethically approved adverts to recruit volunteers to help with the research. Prospective volunteers will learn about the bank in ethically approved information sheets, and in communication with clinical research staff.
The bank will be used by Synairgen and University of Southampton staff (who are working in collaboration with Synairgen) in the Brooke Laboratory. The samples may be processed and analysed by other collaborators of Synairgen (both academic and industry). The day to day decision on who is allowed to use samples is made by Dr Phillip Monk (Synairgen Head of R&D) and who is the Designated Individual. Dr Phillip Monk is following the research plans laid down by Synairgen’s board, and scientific and clinical advisors. The samples are always used to support research into asthma and COPD.
It is not anticipated that the samples will be used for any sensitive research. Some samples may be used to detect genetic differences between disease and non-diseased samples.

Synairgen does not sell the samples for use by other researchers. Synairgen will collaborate with other research groups. Sometimes Synairgen may charge another party for work done as part of the collaboration. Synairgen’s business model is to discover and develop new drugs which will be commercialised one day, either by Synairgen or third parties. Synairgen will gain from licensing activities which may encompass intellectual property relating to inventions made through use of the samples, and from other drug development related data derived outside of the use of the bank.

Synairgen presents its findings at respiratory symposia, and in peer review journals. Synairgen also presents data in its annual report. These data are available on its website.

Appended to this application is a protocol and subject information sheet. These documents are relevant to the contact with volunteers, the collection and subsequent processing of samples, and the underlying objectives for the research.

The samples will be used for respiratory research only. They will be used to understand more about the causes of respiratory disease and to identify new therapies to be used to treat respiratory conditions. For example looking at the biological and physical effects of the common cold on people with asthma and comparing this to healthy controls. This helps gain a better understanding of the mechanisms involved in an asthmatic or COPD response and allows new therapies to be targeted at the areas identified. Samples from the bronchoscopies can then be grown in the lab, the cells can be treated with a cold virus and new treatments can be tested in-vitro.

Samples may also be used to validate assays to support clinical trials run by Synairgen. For example finding, testing and validating assays to measure biomarkers of interferon beta therapy in sputum and blood.

The research is not related to the testing or safety of cosmetics or other consumer products not related to healthcare.

Favourable Opinion

not yet received