HOUSTON, Sept. 24, 2020 /PRNewswire/ -- CNS
Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"),
a biopharmaceutical company specializing in the development of
novel treatments for primary and metastatic cancers of the central
nervous system, today announced it has selected Image Analysis
Group ("IAG") as the image partner for its upcoming Berubicin
clinical trials.
![(PRNewsfoto/CNS Pharmaceuticals, Inc.) (PRNewsfoto/CNS Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/1120277/CNS_Pharmaceuticals_Logo.jpg)
IAG, a leading medical imaging company, will work closely with
CNS during the Berubicin clinical trials to provide critical
imaging services, its proprietary platform DYNAMIKA and imaging
data analysis. IAG has deep expertise in partnering with biotech,
and specifically oncology companies, to provide a centralized
reading and analysis of patient responses in real time. IAG's
scientific and clinical imaging expertise in the field of GBM will
be coupled with IAG's proprietary AI and quantitative image-based
assessments to allow CNS to review efficacy assessments, objective
responses, and to thoroughly explore the advanced treatment
manifestations. GBM therapies often lead to pseudo-progression, a
local tissue reaction resulting from immune cell infiltration,
inflammation, tumor necrosis and oedema which are often
misinterpreted as tumor growth on traditional MRI's.
Pseudo-progression is difficult to distinguish from disease
progression using routine clinical MRI assessments. IAG and
CNS will be utilizing IAG's advanced Artificial Intelligence
(AI)-driven methodologies that provide reliable early efficacy
readouts.
"Adding IAG was a key step in preparation for the recently
developed clinical trials in Berubicin," commented John Climaco, CEO of CNS Pharmaceuticals. "IAG
has an exemplary track record of partnering closely with companies
in the biotech space to provide critical analysis of both efficacy
and patient response, which we believe will be pivotal in advancing
our Berubicin clinical trials. Furthermore, this was yet another
key milestone achieved in our trial preparations as we continue to
take all of the necessary steps to ensure a successful and timely
launch of our Phase II trials. We look forward to leveraging IAG's
extensive expertise, as we plan to initiate our Phase II clinical
trial of Berubicin in adults early next year."
"We are excited to partner with CNS and bring our expertise to
support the optimal trial design, efficient imaging data management
and review. Use of the state-of-the-art and IAG's AI driven
methodologies for imaging data review will allow us to
comprehensively explore Berubicin's efficacy and build significant
scientific evidence, while reducing the development costs,
timelines and uncertainties," commented Dr. Olga
Kubassova, IAG's CEO and scientific founder.
"Advanced imaging methods and computer aided image analysis is
the key to successfully interpret treatment related changes in GBM
and identify responders early," stated Dr. Diana Dupont-Roettger, Chief Scientific Alliance
Officer at IAG. "We are excited to partner with CNS Pharmaceuticals
in the development of Berubicin."
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and
metastatic cancers of the brain and central nervous system. Its
lead drug candidate, Berubicin, is proposed for the treatment of
glioblastoma multiforme (GBM), an aggressive and incurable form of
brain cancer. CNS holds a worldwide exclusive license to the
Berubicin chemical compound and has acquired all data and know-how
from Reata Pharmaceuticals, Inc. related to a completed Phase 1
clinical trial with Berubicin in malignant brain tumors, which
Reata conducted in 2006. In this trial, 44% of patients
experienced a statistically significant improvement in clinical
benefit. This 44% disease control rate was based on 11 patients
(out of 25 evaluable patients) with stable disease, plus
responders. One patient experienced a durable complete response and
remains cancer-free as of February 20,
2020. These Phase 1 results represent a limited patient
sample size and, while promising, are not a guarantee that similar
results will be achieved in subsequent trials. By the end of 2020,
CNS expects to commence a Phase 2 clinical trial of Berubicin for
the treatment of GBM in the U.S., while a sub-licensee partner
undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial
in pediatric GBM patients in Poland. Its second drug
candidate, WP1244, is a novel DNA binding agent that has shown in
preclinical studies that it is 500 times more potent than the
chemotherapeutic agent daunorubicin in inhibiting tumor cell
proliferation.
About IAG
Image Analysis Group (IAG) is a unique
clinical development partner to life sciences companies. IAG
broadly leverages its proprietary image analysis methodologies,
power of our cloud platform DYNAMIKA, years of experience in AI and
Machine Learning as well as bespoke co-development business models
to ensure higher probability for promising therapeutics to reach
the patients. Our independent Bio-Partnering division fuses
risk-sharing business models and agile culture to accelerate novel
drug development.
Forward-Looking Statements
Some of the statements in
this press release are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995, which involve risks and
uncertainties. Forward-looking statements in this press release
include, without limitation, the ability of the Company to initiate
its Phase 2 trial by the end of 2020. These statements relate to
future events, future expectations, plans and prospects. Although
CNS believes the expectations reflected in such forward-looking
statements are reasonable as of the date made, expectations may
prove to have been materially different from the results expressed
or implied by such forward-looking statements. CNS has attempted to
identify forward-looking statements by terminology including
''believes,'' ''estimates,'' ''anticipates,'' ''expects,''
''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,''
''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or
other words that convey uncertainty of future events or outcomes to
identify these forward-looking statements. These statements are
only predictions and involve known and unknown risks, uncertainties
and other factors, including those discussed in the Company's SEC
filings, including under Item 1A. "Risk Factors" in our most
recently filed Form 10-K filed with the Securities and Exchange
Commission ("SEC") and updated from time to time in our Form 10-Q
filings and in our other public filings with the SEC. Any
forward-looking statements contained in this press release speak
only as of its date. CNS undertakes no obligation to update any
forward-looking statements contained in this press release to
reflect events or circumstances occurring after its date or to
reflect the occurrence of unanticipated events.
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SOURCE CNS Pharmaceuticals, Inc.