TIDMIQAI
RNS Number : 2686V
IQ-AI Limited
13 April 2021
IQ-AI Ltd
("IQ-AI" or the "Company")
IQAI commits to Phase1 study for drug candidate in the treatment
of Glioblastoma (GBM), a grade IV brain tumour
IQAI ("the Company"), subject to relevant approvals, has agreed
to finance a Phase 1 clinical trial planned to commence in the
Summer to evaluate the safety and efficacy of Gallium Maltolate
(GaM) in the treatment of Glioblastoma Multiforme (the "Clinical
Trial"). In consideration for financing the Clinical Trial, if
successful, the Company intends to apply for orphan drug status
under the US FDA Orphan Drug Designation Program. This program
grants IP protection to therapy to treat a rare disease or
condition and, if granted, provides market exclusivity to IQ-AI for
seven years post approval. Other territories, such as Europe and
Japan, provide 10- and 8-years exclusivity, respectively.
Recent pre-clinical animal studies have shown that GaM can
significantly reduce the size of tumours within 10 days of
treatment [1], consequently the Company believes that it is now
appropriate to commence human trials as soon as possible. To this
end, an Investigational New Drug (IND) application has been
submitted to the US FDA pending approval of a Phase I trial
scheduled to begin this summer. The trial is being conducted at the
Medical College of Wisconsin (MCW) Cancer Center and is designed
primarily to determine the optimal dose that can be administered
safely to patients. During the two-year study, investigators will
closely monitor the efficacy of GaM in GBM patients. While efficacy
is not the primary aim of a Phase I trial, the investigators will
monitor the size of the tumour using magnetic resonance imaging (IB
Neuro (TM) , has special application for GBM diagnosis and follow
up) throughout the course of the trial. Given the aggressive growth
of GBM, it is possible that the investigators could obtain an early
indication of the efficacy of the treatment during the trial.
GBM is the most common and aggressive primary brain cancer and
has limited treatment options and a dismal prognosis. Current
treatment involves maximal surgical resection followed by radiation
therapy and chemotherapy (bevacizumab and temozolomide). Sadly, the
median survival of patients is only around 14 months.
Dr. Christopher Chitambar, MD, Emeritus Professor of Medicine
and Biophysics, Division of Hematology and Oncology at MCW is the
Chair and Co-principal investigator of the study and, along with
Co-principal investigator Dr. Jennifer Connelly, MD, Associate
Professor of Neurology at MCW, will be enrolling patients in the
study. Both are long-standing collaborators with Kathleen
Schmainda, PhD, a co-founder of IB and a recognised leader in brain
tumour imaging. Together they have researched and developed the use
of GaM in preclinical GBM trials. Since the advanced brain tumour
imaging offered by IQAI is needed to monitor treatment efficacy for
this trial, the investigators approached the Company as a natural
partner to provide resources and expertise for this Phase 1
clinical trial.
Trevor Brown, CEO of IQAI, said, "Current treatment protocols
for GBM have done little to reduce mortality. The pre-clinical
trial produced promising results, but we cannot know whether these
results are replicable in humans until clinical trials are
completed"
GaM is a compound unique in the way it shares certain chemical
properties with iron. Iron is required in far greater amounts by
cancer cells than by normal cells. Preclinical research conducted
by Prof. Chitambar's group has shown that gallium can kill cancer
cells by "hijacking" iron metabolism. Essentially, the cancer cells
are tricked into consuming gallium instead of iron, starving the
tumour and retarding cancer growth. GaM is different from existing
chemotherapy drugs where many are not able to penetrate the brain
and reach tumour cells. GaM can penetrate the brain using a
mechanism which normally functions for the entry of iron. GaM
offers the promise of real treatment advance and improved mortality
rates.
There are approximately 41,000 people being treated for GBM in
the US and Europe [2]. GBM has an incidence of two to three per
100,000 adults per year, and accounts for 52 percent of all primary
brain tumours. Overall, it accounts for about 17% of all tumours of
the brain (primary and metastatic). These tumours tend to occur in
adults between the ages of 45 and 70.
"The discovery that GaM has anticancer activity against
glioblastoma in an animal brain tumour model is extremely exciting;
it opens the door for developing it as a drug for treatment of
glioblastoma in patients", said Dr. Chitambar. "The anticancer
mechanism of GaM applies to other solid tumours as well", Dr.
Chitambar added.
The Directors of the Company accept responsibility for the
contents of this announcement.
1. Molecular Cancer Therapeutics 17:1240, 2018
2. Glioblastoma Multiforme Market, 2024 | GBM Industry Research Report (hexaresearch.com)
For further information, please contact:
IQ-AI Limited
Trevor Brown/Vinod Kaushal/Qu Li Tel: 020 7469 0930
Peterhouse Capital Limited (Financial Adviser and Broker)
Lucy Williams/Heena Karani Tel: 020 7220 9797
-ENDS-
ABOUT Imaging Biometrics, LLC
Imaging Biometrics(R), a subsidiary of IQ-AI Limited (LON:IQAI),
develops and provides visualisation and analytical solutions that
enable clinicians to better diagnose and treat disease with greater
confidence. Through close collaboration with top researchers and
clinicians, sophisticated advancements are translated into
platform- independent and automated software plug-ins which can
extend the base functionality of workstations, imaging systems,
PACS, or medical viewers. By design, IB's advanced visualisation
software seamlessly integrates into routine workflows. For more
information about Imaging Biometrics, visit the company's website
at www.imagingbiometrics.com.
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END
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