Minomic Clinical Study Progresses For MiltuximabTM In Prostate, Bladder, and Pancreatic Cancer
June 28 2017 - 9:37PM
Business Wire
Drug Safety Monitoring Committee Approval to
Proceed to Final Six Patients of Twelve
First-in-human trial on safety and tolerability
passes key stage-gate
Australian immuno-oncology company Minomic International Ltd is
proceeding to the second stage of its pioneering MILGa clinical
trial of MiltuximabTM, a chimeric version of Minomic’s MIL-38
anti-Glypican 1 antibody conjugated to the radioactive isotope
67Gallium.
The MILGa Cancer Imaging Trial is a first-in-human study to
evaluate the safety and tumor targeting of MiltuximabTM in patients
with metastatic prostate, bladder, and pancreatic cancer. The
primary endpoint of the MILGa trial is safety and tolerability of
the MiltuximabTM drug. Secondary endpoints include tumor targeting,
pharmacokinetics and dosimetry to determine relative accumulation
of MILGa in different organs.
Following a pre-specified interim analysis of safety data from
the first six patients, the trial’s independent Drug Safety
Monitoring Committee has formally approved the continuation of the
clinical trial to the final six of twelve subjects.
The first half of the study dosed two patients with pancreatic
cancer and four with prostate cancer. MILGa was well tolerated and
no drug related adverse events were reported.
The Minomic Drug Safety Monitoring Committee is drawn from
radiopharmaceutical and oncology groups at two major public
hospitals in Sydney, Australia. The Committee comprises Dr Vijay
Kumar, Head of Radiopharmaceutical Research at Westmead Hospital,
and Dr Matteo Carlino and Dr Bo Gao, who are both Staff Specialists
Medical Oncology at Blacktown and Westmead Hospitals.
Preclinical studies have demonstrated that MILGa accurately
targets prostate, pancreatic, and bladder cancer cells, and is
well-tolerated and highly specific in mouse models of prostate
cancer.
Minomic’s Chief Executive Officer, Dr Brad Walsh, said, “The
results from this trial are providing us with important safety data
as well as telling us how well the antibody targets different
tumour types. We will use this information to guide the future
development of the drug.”
“Passing this key formal stage in our trial is very
encouraging,” he added. “There are no approved antibody therapies
for prostate or pancreatic cancer, whilst bladder cancer remains
extremely expensive to treat. There is therefore the potential for
major advances in the treatment of these cancers.”
About MIL-38
MiltuximabTM is an IgG1 murine monoclonal antibody (mAb)
directed against Glypican-1 (GPC-1), with demonstrated strong
reactivity to prostate, bladder and pancreatic cancer cell lines.
GPC-1 is also overexpressed in other cancer types, such as
oesophageal cancers and glioblastoma.
About Minomic
Minomic International Ltd is an Australian immuno-oncology
company specialising in therapeutics and diagnostics for solid
tumors, including prostate, bladder and pancreas. Minomic has
developed an in vitro diagnostic test called the MiCheck® test for
the detection of prostate cancer. Minomic is preparing to globally
launch the MiCheck® test, which has been shown to be more than
twice as specific as the existing gold standard Prostate Specific
Antigen (PSA) screening technology. This means that MiCheck®
delivers only 1.5 false positives from every ten samples, compared
to 6 false positive results in every 10 samples using the standard
PSA test. The MiCheck® technology uses Glypican-1, a recently
identified biomarker and other biomarkers never previously used in
prostate cancer diagnosis. Minomic is interested in partnerships or
collaborations with larger pharmaceutical/diagnostic global
partners able to produce, register and distribute the MiCheck® test
and collaborate through registration and commercialization of
future diagnostic imaging and therapeutic applications of the
MIL-38 antibody for prostate cancer.
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version on businesswire.com: http://www.businesswire.com/news/home/20170628006537/en/
MinomicBrad Walsh, +61 413-231-296Ph.D., Chief Executive
Officer