biovu provides a unique, commercial, client-focused, ‘proof-of-concept’ medical imaging service in patients to the global pharmaceutical and biotechnology industries during the early clinical development of new and novel therapeutic agents. Biovu is located near Nottingham, United Kingdom, and utilises sophisticated nuclear imaging technologies, such as gamma scintigraphy and 3D SPECT (single photon emission computed tomography), to evaluate drug disposition in patient volunteers.
Along with dedicated staff expert in nuclear imaging and radiolabelling complex formulations, biovu is able to offer:
- the conduct of studies in a clinical research centre specialising in early phase clinical studies involving radiolabeled products
- the capability to undertake studies in multiple numbers of patient volunteers per day and to accommodate them during overnight and multiple-day stays
- study design and regulatory consultation service, CRF preparation, data management and ICH report writing
- highest compliance to international Cgcp / Cgmp standards with well-established procedures for all aspects of study conduct and data / sample analysis
- expertise in the timely application for CTX for patient-based studies.
biovu has a particular therapeutic focus on:
-Targeted therapeutics,(eg monoclonal antibodies)
-Oncology
-Respiratory disease
-Gastroenterology.
More details on each of these areas are outlined below.
Targeted therapeutics, (eg monoclonal antibodies)
Drug disposition is becoming increasingly important in the study of new therapeutic areas. Scintigraphic studies are valuable in the evaluation of tumour targeted delivery systems, such as monoclonal antibodies (mAbs), peptides and receptor binding molecules. Therapeutic effects may rely on conventional drug action or may be enhanced by conjugation to a carrier. Imaging the accumulation of such agent has already proven to be of clinical value. In the field of site-specific drug delivery and tumour targeting, imaging tumour uptake has obvious implications for speeding up the drug dvelopment timescale. The use of a targeting agent offers a vector for the delivery of a range of toxic agents. In the field of nuclear medicine, receptor binding agents, peptides and monoclonal antibodies are increasingly being used for the delivery of toxic radionuclides. Monoclonal antibodies are particularly suited to evaluation by gamma scintigraphy and have the potential for applications in many indications, e.g. rheumatoid arthritis, ulcerative colitis and Crohn’s disease, where the therapeutic compound is targeted to a specific marker of inflammation. As these targets are most evident in diseased individuals, the specificity of these molecules must be assessed in patients (Phase Iia). biovu's whole body imaging capability can demonstrate ‘proof of concept’ in a preliminary Phase IIa study prior to launching a full-scale in-patient clinical trial.
Oncology
Current treatments, such as chemotherapy, tend to be non-specific and have highly unpleasant side effects. To overcome this problem, many new treatments are being designed which aim to specifically locate and target diseased cells. Nuclear imaging studies play an essential part in the clinical evaluation of these targeted drugs and associated delivery systems. Whole-body imaging, using gamma scintigraphy, can visualise the uptake of a radiolabelled drug by cancer cells in target organs and in sites of potential toxicity, assisting with the evaluation of different routes of administration. 3D (SPECT) imaging can be used to assess the depth of tumour penetration in larger solid tumour masses. In addition, biovu studies can help clarify required dosages and may even indicate the need for special techniques to improve the localisation of the treatment. biovu is extremely well placed to take advantage of the burgeoning number of targeted therapeutics currently entering development for two main reasons.
Firstly, the imaging technology has certain advantages:
·scintigraphic imaging is currently the only means of effectively evaluating the whole-body disposition of a therapeutic agent.
·ability to demonstrate not only the targeting of primary lesions but also secondary metastatic deposits
·co-registration with MRI images providing anatomical context.
·invaluable for detecting accumulation at unwanted sites such as bone marrow, kidneys and liver.
Secondly, given the nature of cancer, Phase I studies in the area of oncology tend to be conducted in patients as opposed to healthy subjects. For this indication, biovu studies are conducted at an early stage of the development process when the number of candidate molecules remains high.
Respiratory disease
biovu’s access to an advanced scintigraphic imaging capability,allows the precise visualisation of the delivery of inhaled products for the treatment of respiratory diseases to the diseased lung, in conditions such as asthma, chronic bronchitis and cystic fibrosis. Understanding regional lung deposition is particularly important when considering administration of drugs to the diseased lungs of patients because the deposition can be very different from that observed in a healthy volunteer during Phase I trials. biovu’s studies at Phase IIa of drug development are instrumental in demonstrating ‘proof-of-concept’ for pulmonary delivered products as early in development as possible. This allows formulation adjustments to be made to optimise delivery, to the precise amount of drug, to the appropriate area of the lungs, for the target patient group.
Gastroenterology
Over recent years, there has been significant growth in the development of treatments for disturbed gastrointestinal (GI) function, seen in conditions such as inflammatory bowel disease, irritable bowel syndrome and gastro-oesophageal reflux disorder. Using scintigraphic imaging, biovu is able to visualise the performance of oral dosage forms in the gastrointestinal tract of patients with the relevant pathophysiology. In addition, subtle whole, regional or local differences in GI transit can be assessed in a small number of relevant patients to establish ‘proof-of-concept’ for a new drug designed to alter motility before commencing more costly and time-consuming later phase therapeutic studies.
| Contact Details: |
| Mere Way |
| Nottingham |
| |
| NG11 6JS |
| United Kingdom |
| Tel: | +44 (0) 1865 823136 |
| Fax: | +44 (0) 1865 823136 |
| Email: | namplett@biovu.co.uk |
| WWW: | www.biovu.co.uk/
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