A Phase II Study to Evaluate the Efficacy of Anti-Fibrin Humanized Monoclonal Antibody(DI-DD3B6/22-80B3) Fab' Fragment (ThromboView®) Conjugated With Technetium-99m in the Detection of Pulmonary Emboli

The aim of the study is to determine the diagnostic accuracy of 99mTc ThromboView® SPECT imaging for the detection of acute pulmonary embolism (PE) in patients for whom there is a moderate to high clinical suspicion for PE.

Start Date01 Sep 2007

Sponsor / Collaborator

Agen Biomedical Ltd.

ACTRN12606000048583

/ Not yet recruitingPhase 1/2

Extension to Multi Centre, Phase Ib Safety Study of anti-fibrin humanised monoclonal antibody (DI-DD3B6/22-80B3) Fab’ Protein Fragment (ThromboView®) conjugated with Technetium-99m in the Detection of Pulmonary Emboli

Start Date13 Feb 2006

Sponsor / Collaborator

Agen Biomedical Ltd.

NCT00123734

/ CompletedPhase 2

Phase II Clinical Trial to Evaluate the Accuracy of Anti-Fibrin Humanized Monoclonal Antibody (DI-DD3B6/22-80B3) Fab' Protein Fragment (ThromboView) Conjugated With Technetium-99m in the Detection of Deep Vein Thrombosis

The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging.
The diagnosis of DVT remains problematic in:
patients with suspected first DVT who have a moderate or high pre-test probability (PTP) for DVT and a normal compression ultrasound (CUS);
patients with suspected recurrent DVT; and
patients in whom CUS or contrast venography is technically difficult or not feasible due to patient characteristics.
In patients with suspected first DVT who have a moderate or high PTP and a normal CUS, DVT occurs in up to 10% of cases. Thus, additional diagnostic testing is required, such as venography or serial CUS, so that DVT is not missed, but these approaches are costly and invasive.
In patients with suspected recurrent DVT, currently used diagnostic approaches are problematic because they all have limitations in differentiating old disease from true recurrent disease.
CUS is technically difficult in selected patients, particularly those who are obese.
Contrast venography is the gold standard diagnostic test for DVT to which all other diagnostic venous imaging modalities for DVT are compared and judged. The Food and Drug Administration (FDA) requires that a new diagnostic test for DVT be assessed against venography.
[99mTc] ThromboView® is a novel diagnostic test based on a 99mTc-labeled monoclonal antibody specific for D-dimer fragments of cross-linked fibrin that are found in acute DVT. After intravenous injection of [99mTc] ThromboView®, there is uptake of the monoclonal antibody by acute, D-dimer rich, venous thrombi. This is visualized with nuclear medicine imaging as an area of increased radioisotope activity that corresponds to the location of DVT.
Based on the biologic and imaging characteristics of [99mTc] ThromboView®, this diagnostic test has the potential to:
identify small non-occlusive proximal DVT or distal DVT in patients with a moderate or high PTP and normal CUS;
differentiate old from new DVT in patients with suspected recurrent DVT;
diagnose or exclude DVT in patients in whom CUS is not technically feasible; and
provide an alternative to venography that is non-invasive, has no contrast-related toxicity and is easily administered.
The present study is the first phase II clinical trial of [99mTc] ThromboView® in patients with suspected initial or recurrent DVT in whom DVT has been confirmed or excluded by venography. A phase II clinical trial to investigate the diagnostic accuracy of [99mTc] ThromboView® is justified because:
ThromboView® was well tolerated, with no significant toxicity in studies involving animals and healthy volunteers; and
it has shown promise in Phase I trials as a non-invasive diagnostic test for acute DVT.

Start Date01 Mar 2005

Sponsor / Collaborator

Agen Biomedical Ltd.

100 Clinical Results associated with Agenix Ltd.

0 Patents (Medical) associated with Agenix Ltd.

Literatures (Medical) associated with Agenix Ltd.

15 Sep 2011·American Journal of Respiratory and Critical Care MedicineQ1 · MEDICINE

Detection of Pulmonary Emboli With ^99mTc-Labeled Anti–D-dimer (DI-80B3)Fab′ Fragments (ThromboView)

Q1 · MEDICINE

Article

Author: Morris, Timothy A. ; Macfarlane, David ; Kaatz, Scott ; Douketis, James D. ; Yusen, Roger D. ; Ginsberg, Jeffrey S. ; Smart, Richard C. ; Gerometta, Michael ; White, Richard H.

RATIONALEWe report a new method to diagnose acute pulmonary embolism (PE) by single photon emission computerized tomography (SPECT) after administration of (99m)Tc-labeled anti-D-dimer (DI-80B3) monoclonal antibody Fab' fragments. This novel technique provides an additional approach to diagnosing PE in patients for whom other methods are nondiagnostic or contraindicated.OBJECTIVESWe performed a prospective, multicenter study to investigate the sensitivity and specificity of (99m)Tc-DI-80B3/SPECT in patients with suspected acute PE.METHODSSubjects with a moderate to high clinical probability of PE or a positive D-dimer test underwent a PE-protocol contrast-enhanced multidetector thoracic computed tomography (CT) scan as well as (99m)Tc-DI-80B3/SPECT (0.5 mg (99m)Tc-DI-80B3 intravenously followed by a thoracic SPECT 2.5 h later). Separate and independent adjudication committees, blinded to clinical data and other test results, interpreted the (99m)Tc-DI-80B3/SPECT scans (PE detected as foci of abnormally increased (99m)Tc uptake) and the thoracic CT scans using Prospective Investigation of Pulmonary Embolism Diagnosis II criteria.MEASUREMENTS AND MAIN RESULTSOf the 52 patients who were enrolled and completed both tests, 42 had both evaluable SPECT scans and thoracic CT scans. Using the criterion standard (thoracic CT scan) there were 21 patients with PE and 21 without. (99m)Tc-DI-80B3/SPECT had a sensitivity of 76.2% (95% confidence interval, 52.8-91.8%) and a specificity of 90.5% (95% confidence interval, 69.8-98.8%). Treatment-related serious adverse events did not occur.CONCLUSIONS(99m)Tc-DI-80B3/SPECT was sensitive and specific for acute PE in subjects with moderate to high clinical probability of PE or a positive D-dimer test. (99m)Tc-DI-80B3/SPECT demonstrated an acceptable safety profile and avoids exposure to contrast.

01 Dec 2008·Journal of General VirologyQ3 · MEDICINE

A glycosylated peptide in the West Nile virus envelope protein is immunogenic during equine infection

Q3 · MEDICINE

Article

Author: Toye, Philip ; Cheah, Wai Yuen ; Hall, Roy A. ; Bossart, Katharine N. ; Wang, Lin-Fa ; Clark, David C. ; Sánchez, Melissa D. ; Hobson-Peters, Jody

Using a monoclonal antibody directed to domain I of the West Nile virus (WNV) envelope (E) protein, we identified a continuous (linear) epitope that was immunogenic during WNV infection of horses. Using synthetic peptides, this epitope was mapped to a 19 aa sequence (WN19: E147–165) encompassing the WNV NY99 E protein glycosylation site at position 154. The inability of WNV-positive horse and mouse sera to bind the synthetic peptides indicated that glycosylation was required for recognition of peptide WN19 by WNV-specific antibodies in sera. N-linked glycosylation of WN19 was achieved through expression of the peptide as a C-terminal fusion protein in mammalian cells and specific reactivity of WNV-positive horse sera to the glycosylated WN19 fusion protein was shown by Western blot. Additional sera collected from horses infected with Murray Valley encephalitis virus (MVEV), which is similarly glycosylated at position E154 and exhibits high sequence identity to WNV NY99 in this region, also recognized the recombinant peptide. Failure of most WNV- and MVEV-positive horse sera to recognize the epitope as a deglycosylated fusion protein confirmed that the N-linked glycan was important for antibody recognition of the peptide. Together, these results suggest that the induction of antibodies to the WN19 epitope during WNV infection of horses is generally associated with E protein glycosylation of the infecting viral strain.

01 Jan 1995·Progress in clinical and biological research

A rapid test for endotoxin in whole blood.

Article

Author: Corbett, M E ; Shi, W ; Elms, M J ; Cox, A ; Manickavasagam, B ; Rylatt, D ; McArthur, M J ; Kemp, B E ; O'Hara, J ; Wilson, K

A rapid whole blood agglutination test has been developed for the detection of endotoxin. The test reagent consists of polymyxin B (PmB) conjugated to the Fab fragment of the anti-glycophorin antibody 1C3/86. After addition of reagent to whole blood, red cell agglutination occurs within two minutes in samples from endotoxaemic patients or with the addition of either whole Gram negative bacteria, supernatants from Gram negative bacterial cultures or purified endotoxin. In clinical samples there was a strong correlation (r = 0.83) between the strength of agglutination and the level of endotoxin measured by the Limulus amaebolysate test (LAL). The prospect of a rapid and accurate test for endotoxin may enable better clinical management of Gram negative sepsis.

News (Medical) associated with Agenix Ltd.

25 Oct 2012

·www.biospace.com

Agenix Limited to Acquire Diagnostic Device Technology From Tyrian Limited

Melbourne Australia 25 October 2012: Agenix Limited (ASX: AGX) today announced it had entered an agreement with Tyrian Diagnostics Limited (ASX: TDX) to license its rapid point-of-care human diagnostic technology in a share exchange transaction. Under the terms of the agreement, Agenix will license exclusive world-wide royalty free rights to the human health application for Tyrian’s proprietary DiagnostIQ® rapid point-of-care test platform. In return, Agenix will provide Tyrian with Agenix shares to the value of $0.5million payable in installments to be completed by June 2014. The DiagnostIQ® platform comprises a patented disposable test device which can be used for various applications either alone or together with the DiagnostIQ® Reader for various human, animal and agricultural applications to determine action to be taken at the point of care for human and veterinary tests or point of need for agricultural and environmental tests. Agenix has licensed the rights to develop the DiagnostIQ® platform for human health applications and aims to develop the technology into a micro-array device so that it will process multiple human health diagnostic tests on the one system. The device is currently licensed to Bayer CropScience AG for an agricultural application. In an addition to the licence, to be finalised in the near future, Agenix will also acquire a patent for Tyrian’s antibody-based test for active tuberculosis. This patent covers a novel biomarker, discovered by Tyrian, which has the potential to distinguish patients with active TB infection from those that have been infected in the past, or have been vaccinated. Agenix Limited Chairman and Chief Executive Officer Nicholas Weston said, “This acquisition advances our product pipeline and adds to our human health diagnostics business. We now have a platform for human health array and micro-array technology developers globally, as well as a medical device product for our expanding China business.” Tyrian Limited Chairman, Roger Amos said the licence agreement with Agenix was part of the company’s continued efforts by Tyrian to monetise its diagnostic testing assets following the recent company restructuring. It follows a 2011 licence to SpeeDx Pty Ltd for active TB testing approaches outside of the antibody field. Mr Weston said Agenix did not anticipate the closing of the deal would impact its immediate cash requirements. The shares to be issued to Tyrian currently represent less than 20% of the issued capital and will be fully paid ordinary shares ranking equally with existing listed shares. The share issue will be made within Agenix’s 15% annual placement capacity under ASX Listing Rule 7.1 and will not require shareholder approval. For more information please contact: Nicholas Weston Agenix Limited Tel: 1300 132 551 Andrew Geddes Tel: (02) 9555 4453

CollaborateAntibodyAcquisition

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100 Translational Medicine associated with Agenix Ltd.

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