CNS Pharmaceuticals and Image Analysis Group Partner to Further the Development of Berubicin
24 September 2020 - 10:00PM
via NetworkWire -- 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.
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 MRIs.
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.
CONTACTS:
Investor Relations Contact
James SaliernoThe Ruth
Group646-536-7028jsalierno@theruthgroup.com
Media ContactKirsten ThomasThe Ruth Group(508)
280-6592kthomas@theruthgroup.com
Wire Service Contact NetworkWire (NW) New York,
New York www.NetworkWire.com 212.418.1217 Office
Editor@NetworkWire.com
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