MILGa-01: A first in human study to evaluate the safety and tolerability of monoclonal antibody conjugate MILGa (MIL-38/Gallium67) in patients with advanced prostate, bladder and pancreatic cancer.

Start Date18 Aug 2016

Sponsor / Collaborator

Minomic International Ltd.

100 Clinical Results associated with Minomic International Ltd.

0 Patents (Medical) associated with Minomic International Ltd.

Literatures (Medical) associated with Minomic International Ltd.

01 Nov 2023·Urologic Oncology: Seminars and Original Investigations

Development and evaluation of the MiCheck® Prostate test for clinically significant prostate cancer

Article

Author: Bailen, James L ; Pieczonka, Christopher M ; Henderson, R Jonathan ; Shore, Neal D ; Walsh, Bradley J ; Saltzstein, Daniel R ; Ruterbusch, Julie J ; Concepcion, Raoul S ; Levin, Rachel A ; Beebe-Dimmer, Jennifer L ; Gillatt, David A ; Campbell, Douglas H ; Lu, Yanling ; Chan, Daniel W ; Deng, Niantao ; Wissmueller, Sandra ; Le, Thao Ho ; Siddireddy, Jaya Sowjanya ; Polikarpov, Dmitry M

BACKGROUNDThere is a clinical need to identify patients with an elevated PSA who would benefit from prostate biopsy due to the presence of clinically significant prostate cancer (CSCaP). We have previously reported the development of the MiCheck® Test for clinically significant prostate cancer. Here, we report MiCheck's further development and incorporation of the Roche Cobas standard clinical chemistry analyzer.OBJECTIVESTo further develop and adapt the MiCheck® Prostate test so it can be performed using a standard clinical chemistry analyzer and characterize its performance using the MiCheck-01 clinical trial sample set.DESIGN, SETTINGS, AND PARTICIPANTSAbout 358 patient samples from the MiCheck-01 US clinical trial were used for the development of the MiCheck® Prostate test. These consisted of 46 controls, 137 non-CaP, 62 non-CSCaP, and 113 CSCaP.METHODSSerum analyte concentrations for cellular growth factors were determined using custom-made Luminex-based R&D Systems multi-analyte kits. Analytes that can also be measured using standard chemistry analyzers were examined for their ability to contribute to an algorithm with high sensitivity for the detection of clinically significant prostate cancer. Samples were then re-measured using a Roche Cobas analyzer for development of the final algorithm.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSISLogistic regression modeling with Monte Carlo cross-validation was used to identify Human Epidydimal Protein 4 (HE4) as an analyte able to significantly improve the algorithm specificity at 95% sensitivity. A final model was developed using analyte measurements from the Cobas analzyer.RESULTSThe MiCheck® logistic regression model was developed and consisted of PSA, %free PSA, DRE, and HE4. The model differentiated clinically significant cancer from no cancer or not-clinically significant cancer with AUC of 0.85, sensitivity of 95%, and specificity of 50%. Applying the MiCheck® test to all evaluable 358 patients from the MiCheck-01 study demonstrated that up to 50% of unnecessary biopsies could be avoided while delaying diagnosis of only 5.3% of Gleason Score (GS) ≥3+4 cancers, 1.8% of GS≥4+3 cancers and no cancers of GS 8 to 10.CONCLUSIONSThe MiCheck® Prostate test identifies clinically significant prostate cancer with high sensitivity and negative predictive value (NPV). It can be performed in a clinical laboratory using a Roche Cobas clinical chemistry analyzer. The MiCheck® Prostate test could assist in reducing unnecessary prostate biopsies with a marginal number of patients experiencing a delayed diagnosis.

31 Jul 2023·Translational andrology and urology

Novoglan device for treatment of adult phimosis: Novoglan-01 open-label clinical trial on safety, efficacy and tolerability.

Article

Author: James, Andrew ; Polikarpov, Dmitry ; Gillatt, David ; Doosti, Hassan ; Chung, Eric ; Mazure, Hubert ; Campbell, Douglas

BackgroundAt present, the only definitive treatment for adult phimosis is circumcision, which is a surgical removal of the prepuce. Novoglan is a novel device that could offer patients with phimosis an alternative to surgery. It is based on application of custom-moulded balloons for gradual skin remodelling and prepuce dilatation. This open-label clinical trial aimed to investigate the safety, efficacy and tolerability of the Novoglan treatment.MethodsA prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of 4-8 weeks with patient's degree of phimosis assessed before and at 6-8 weeks after the initiation of the treatment. Participants were also asked to complete questionnaires aimed to assess the safety and tolerability of the Novoglan treatment.ResultsThe treatment was successful with improved foreskin retraction in 90% of patients and all patients achieving full foreskin retraction after the treatment. Ninety-five percent of patients reported reduced level of anxiety, and over 60% of patients reported reduced pain/discomfort during sexual activity or in general. Similarly, 95% of patients were moderately-to-very satisfied with the treatment and would recommend Novoglan to others. No adverse events were observed and only 15% of participants reported minor side effects.ConclusionsThe Novoglan-01 trial demonstrated high safety, efficacy and tolerability of the Novoglan treatment for adult phimosis and its high potential as a conservative alternative to circumcision or steroid cream treatment.Trial RegistrationThe Novoglan-01 study has been registered with the Australia and New Zealand Clinical Trial Registry under the reference ACTRN 1262 10009 24853, dated 15 July 2021.

01 May 2022·Analytica Chimica ActaQ2 · CHEMISTRY

Assessing the activity of antibodies conjugated to upconversion nanoparticles for immunolabeling

Q2 · CHEMISTRY

Article

Author: Cao, Yueying ; Zheng, Xianlin ; Wu, Jiehua ; Piper, James A ; Packer, Nicolle H ; Lu, Yanling ; Lu, Yiqing

Surface modification and functionalization is typically required to engineer upconversion nanoparticles (UCNPs) for biosensing and bioimaging applications. Nevertheless, despite various antibody conjugation methods having been applied to UCNPs, no consensus has been reached on the best choice, as the results from individual studies are largely unable to be compared due to inadequate assessment of the properties of the conjugated products. Here, we introduce a systematic approach to quantitatively evaluate the biological activity of antibody-conjugated UCNPs. We determine that the optimal antibody conjugation efficiency to our colominic acid polysaccharide-coated UCNPs via 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide/N-hydroxy succinimide (EDC/NHS) coupling is approximately 70%, corresponding to 16 antibodies per nanoparticle of 63 nm hydrodynamic diameter, with on average 12 of the 16 antibodies maintaining their affinity to the target antigens. The binding ability of the antibody-conjugated UCNPs to the antigen was well preserved, as verified by enzyme-linked immunosorbent assay (ELISA), flow cytometry, and cellular imaging. This is the first study to quantitate the active antibody binding capacity of polysaccharide coated UCNP nanoparticles, offering a practical guideline for benchmarking functionalised UCNPs in future studies.

100 Deals associated with Minomic International Ltd.

100 Translational Medicine associated with Minomic International Ltd.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

MILGa ( GPC1 )	Prostatic Cancer More	Pending

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Minomic International Ltd.

Overview

Related

Corporation Tree

Pipeline

Pipeline Snapshot as of 26 Nov 2024

Current Projects

Deal

Translational Medicine

Profit

Grant & Funding(NIH)

Investment

Financing