CNS Pharmaceuticals and Image Analysis Group Partner to Further the Development of Berubicin

HOUSTON, Sept. 24, 2020 (GLOBE NEWSWIRE) -- 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.

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Released September 24, 2020