Date: 2015-01-08
Type of information: Recruitment of the first patient
phase: 1-2a
Announcement: recruitment of the first patient
Company: Advanced Accelerator Applications (France)
Product: 99mTc-rhAnnexin V-128
Action
mechanism: radiopharmaceutical/protein. 99mTc-rhAnnexin V-128 is a wild-type annexin, labeled with Technetium-99m (Tc-99m), a medical isotope widely used in diagnostic imaging. This single photon emission computed tomography (SPECT) radiopharmaceutical agent aims to detect early cell stress and apoptosis in vivo to assess programmed cell death in a number of pathological conditions, including rheumatoid arthritis, ankylosing spondylitis and cardiovascular diseases. The product, based on a specifically designed recombinant form of Annexin V-128, is being developed as a single lyophilized vial 99mTc-rhAnnexin V-128 kit by AAA. 99mTc-rhAnnexin V-128 could be used as an adjunct for the diagnosis of early stage rheumatoid arthritis and ankylosing spondylitis and for the assessment of response to treatment of these diseases. AAA has an exclusive, worldwide license to develop proprietary molecular imaging products based on Annexin V-128.
Disease: rheumatoid arthritis, ankylosing spondylitis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Diagnostic
Country: Switzerland
Trial
details: Primary objective of this phase I/IIa study is to determine the safety and tolerability of medical imaging with 99mTc-rhAnnexin V-128. Secondary objectives aim to determine the biodistribution, pharmacokinetics and radiation dosimetry of 99mTc-rhAnnexin V-128, to demonstrate the time-dependant distribution and localization of 99mTc-rhAnnexin V-128 both in RA and AS patients and to determine ability of early imaging with 99mTc-rhAnnexin V-128 to evaluate the presence of lesions before and after short term treatment of either RA or AS patients. (NCT02328027)
Latest
news: * On January 8, 2015, Advanced Accelerator Applications, an international specialist in Molecular Nuclear Medicine (MNM), announced the enrollment of the first patient in the Phase I/IIa clinical trial to evaluate the safety, pharmacokinetics and dosing of key diagnostic product candidate 99mTc-rhAnnexin V-128 in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). The study will also assess the ability of 99mTc-rhAnnexin V-128 to identify the disease and to monitor the effectiveness of current drug treatment. 99mTc-rhAnnexin V-128 is a single photon emission computed tomography (SPECT) radiopharmaceutical agent being developed to detect early cell stress and apoptosis (programmed cell death) in a number of pathological conditions including rheumatoid arthritis and ankylosing spondylitis. In this Phase I/IIa clinical trial 20 patients will be enrolled to receive two doses of 99mTc-rhAnnexin V-128, one at baseline and one after drug treatment. The principal investigator of the study is Prof. John Prior, University Hospital of Lausanne, Switzerland. A Phase I trial has been completed at the University of Ottawa Heart Institute in Canada to assess the safety, pharmacokinetics and dosing of 99mTc-rhAnnexin V-128 in 12 healthy volunteers. The results are currently being analysed. The principal investigator of this study is Dr Terrence Ruddy.
