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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) on Track to Begin Potentially Pivotal Phase 2 GBM Trial This Quarter for Berubicin

  • During Phase 1 trials, Berubicin showed 44% of patients experienced a clinical benefit of stable disease or better, one being cancer-free after 14 years, and two patients reporting significant tumor reduction (up to 80%)
  • Additional research to be conducted by sublicensee partner WPD Pharmaceuticals, Inc. in Poland, including the first-ever pediatric trial
  • The glioblastoma multiforme (“GBM”) treatment market is expected to reach $1.4 billion by 2027
  • CNS Pharma positioning to secure a leading role in treating GBM

A potentially pivotal Phase 2 trial is on track to commence during Q2 2021 by CNS Pharmaceuticals (NASDAQ: CNSP). This trial is currently planned to include up to 243 subjects, randomized 2:1 (162 Berubicin/81 Lomustine) with an interim analysis when 50% of the subjects reach six months in the study. Berubicin is the lead drug candidate that CNS is working with to use against one of the most aggressive and deadly forms of treatment-resistant cancers that form in the brain – Glioblastoma Multiforme (“GBM”).

GBM is a non-discriminatory type of cancer that can strike any person at any time in their life. Of all primary malignant brain tumors, GBM accounts for 48% of them. Unfortunately, since first identified in the 1920s, the FDA has only ever approved four drugs and one device for GBM treatment. However, none of these FDA-approved approaches have succeeded in increasing life expectancy with GBM more than a few months (https://ibn.fm/JwIWV).

Berubicin is a synthetic 4’-O-Benzylated doxorubicin analog, topoisomerase II Inhibitor, highly cytotoxic, and highly lipophilic. As the first anthracycline to cross the blood-brain barrier, Berubicin was specifically designed to attack a variety of primary brain cancers and cancers metastatic to the brain.

Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center, is the original developer of Berubicin. The Phase 1 trial was completed by Reata Pharmaceuticals (NASDAQ: RETA) and showed promising results, with 44% of the trial patients experiencing significant improvement in clinical benefit. One patient from this trial has survived cancer-free for the last 14 years, while two others saw a reduction in tumor size of up to 80 percent.

CNS entered into an asset purchase agreement with Reata in 2017 and as a result holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all the requisite data and know-how from Reata related to the Phase 1 trial.

In addition to the potentially pivotal trial commencing in the United States and expected to expand to include a global footprint, two additional trials are planned in Poland by CNS’s partner WPD Pharmaceuticals. WPD will be conducting two grant-funded studies including one Phase 2 adult GBM trial to commence in Q2 2021 and the first-ever Phase 1 pediatric trial for malignant gliomas set to commence during H2 2021.

CNS hopes to expand Berubicin studies to include other cancers, such as:

  • Primary Brain Tumors
    • Relapsed high-grade gliomas with an estimated patient population size of 15,000
  • Brain Metastases – Combination with Radiation Therapy
    • Small Cell Lung Cancer has an estimated patient population size of 56,500
    • Non-Small Cell Lung Cancer has an estimated patient population of 56,000
    • Metastatic Breast Cancer has an estimated patient population of 45,000
  • CNS Lymphoma
    • 2nd line of defense after Methotrexate failure with a potential 1,200 patient population (there is currently no 2nd line therapy after Methotrexate)

The GBM treatment market is expected to grow from $662 million in 2017 to $1.4 billion in 2027, growing at a CAGR of 7.5% across eight major markets. The eight major markets include the U.S., Germany, Italy, France, Japan, the UK, Spain, and urban China (https://ibn.fm/8tcnS). With Berubicin’s ability to breach the BBB and the planned trials, CNS Pharmaceuticals is uniquely positioned to capitalize on this market growth and secure a leading role in the sector.

The interim Berubicin trial data on the Polish trial in adult GBM patients is expected in the first half of  2022. Multiple value-driving milestones are expected to transpire for CNS Pharmaceuticals during 2021, including growth opportunities for its other drug candidate currently in development, WP1244, a DNA-binding agent believed to be 500 times more potent than daunorubicin in inhibiting tumor cell proliferation, and potentially targeting brain cancers, pancreatic cancers, ovarian cancers, and lymphoma.

For more information, visit the company’s website at www.CNSPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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