Breakthroughs Target the Killer Cancer Affecting McCain
A new drug that attacks the precise form of deadly brain cancer that has stricken GOP Sen. John McCain of Arizona is being hailed as a po...
CNS is developing Berubicin, a breakthrough drug for the treatment of the most deadly form of brain cancer.
Berubicin was created at MD Anderson Cancer Center, the largest cancer and research institute in the world.
Berubicin’s Phase I clinical trial yielded promising results showing clinical activity in 44% of patients*.
Berubicin is the first of its class of drugs to cross the blood brain barrier (BBB) and reach cancer cells in brain tumor patients.
Led by industry leading scientists and executives with decades of experience developing drugs and bringing medical products to market.
Signed a collaboration agreement with Reata Pharmaceuticals, a $700M+ NASDAQ listed company, to further advance the development of brain cancer technologies.
CNS intends to list on the NASDAQ in 2018.
*Study not designed to demonstrate safety and effectiveness
In the United States, an estimated 78,980 new cases of brain tumor are expected to be diagnosed in 2018. Of these, the deadliest form is Glioblastoma Multiforme (GBM), responsible for the highest number of cases of all malignant tumors, with 12,500 cases projected in 2017 and 12,760 in 2018.*
Glioblastoma is the type of brain cancer that killed Senator Ted Kennedy and Vice President Joe Biden’s son. Unfortunately, Senator John McCain was also recently diagnosed with this deadly disease.
GBM is the most aggressive and common primary brain cancer in adults. It is highly invasive, virtually incurable, and the primary target for our lead drug candidate Berubicin.
Despite decades of research, the survival outcomes for patients with GBM remain virtually unchanged, with a median survival time of 14.6 months. * CBTRUS report
Berubicin, was created at the MD Anderson Cancer Center by Dr. Waldemar Priebe. Dr. Priebe is the founder of CNS Pharmaceuticals.
Berubicin is considered a breakthrough technology because...
What is an anthracycline?
An anthracycline is a class of drugs that are among the most effective anticancer treatments ever developed and are effective against more types of cancer than any other class of chemotherapeutic agents for cancers like breast, ovarian, leukemia, lymphoma, testicular, and others.
While this class of drugs has been extremely successful at treating even the most aggressive types of cancers, unfortunately in over 60 years of clinical research, anthracyclines have NEVER been shown to cross the blood-brain barrier (BBB) and impact deadly brain cancers… until now.
The very promising results of the Phase I clinical trial of Berubicin in GBM patients, completed by Reata Pharmaceuticals, demonstrated significant anti-tumor activity in 44% of the treated patients.*
It consisted of 61 patients which were enrolled in two separate studies. Both dose finding and safety were studied in patients with GBM or other brain cancers.
Berubicin has also been granted Orphan Drug status by the FDA in the US.
In 2018, with the funding to be secured from this equity crowdfunding campaign and a planned NASDAQ IPO, CNS expects to commence its Phase 2(a) clinical trial of Berubicin for the treatment of GBM.
In late 2017, CNS entered into a collaboration agreement with Reata Pharmaceuticals, currently a $700M+ NASDAQ listed company, to further advance the development of brain cancer technologies.
*Based on all tumor cell lines so far tested, Berubicin has been significantly more potent than doxorubicin, more cytotoxic, and a more potent topoisomerase II poison.
*Study not designed to demonstrate safety and effectiveness
At 2 minutes and 44 seconds into the video above, there is an animation that will show you how Berubicin is able to cross the BBB and attack a tumor.
The current standard for treatment for GBM is surgery, radiation, and chemotherapy with Temozolomide (TMZ). TMZ, the current standard of treatment for GBM, has limited efficacy.
Drugs currently used for the treatment of other cancers are not effective for the treatment of brain tumors. The brain’s protective mechanism, the BBB, is responsible for shielding brain tumors from the existing and potential new anti-cancer agents. The BBB makes development of effective drugs for brain tumors very difficult.
The lack of progress in the treatment of GBM provides a tremendous opportunity to identify better drugs like Berubicin.
If approved, Berubicin has the potential to realize a multi-billion dollar opportunity as a stand-alone or combination therapy for GBM and other cancers.
Approximately 40% of GBM patients have a genetic variation, which makes their tumors initially more responsive to Temozolomide (TMZ). TMZ is the current standard of care for these patients. Nearly all of these patients will quickly become resistant to TMZ. Berubicin could be prescribed after TMZ’s failure.
In case of the remaining 60% of GBM patients, TMZ is ineffective and Berubicin could be prescribed as a primary drug treatment.
In 2009, Schering reported worldwide sales of temozolomide (TMZ) of $1 billion. Current numbers for temozolomide market share may be lower since launch of generics in 2013.
As of now, there is no standard of care for recurrent GBM. Bevacizumab (Avastin) is a recently approved by FDA drug for chemotherapy for glioblastoma at relapse; however it does not improve survival.
Short-term efficacy of the current standard of treatment and low survival rate of GBM patients and other related central nervous system malignancies, create a significant unmet need and financial opportunity.
Berubicin has the potential to become the standard of care treatment for recurrent and TMZ resistant GBM. CNS will plan future clinical trials to establish Berubicin as an upfront treatment for glioblastoma. If approved, CNS believes that Berubicin has the potential to realize a multi-billion dollar opportunity as a stand-alone or combination therapy for GBM and other cancers.
John M. Climaco, JD is the CEO of CNS Pharmaceuticals, Inc. For 15 years Mr. Climaco has served in leadership roles in a variety of healthcare companies. Recently Mr. Climaco served as the Executive Vice-President of Perma-Fix Medical S.A where he managed the development of a novel method to produce Technitium-99. Previously Mr. Climaco served as President and CEO of Axial Biotech, Inc., a DNA diagnostics company. In the process of taking Axial from inception to product development to commercialization, Mr. Climaco created strategic partnerships with Medtronic, Johnson & Johnson and Smith & Nephew. Mr. Climaco currently serves as a director of several public companies including Moleculin Biotech, Inc., pharmaceutical company focused on anti-cancer drug candidates. Mr. Climaco also served as a director of PDI, Inc., a provider of outsourced commercial services to pharma companies, and InfuSystem Holdings, Inc., the largest supplier of infusion services to oncologists in the US.
Sandra L. Silberman, M.D., Ph.D. is the Chief Medical Officer of CNS Pharmaceuticals. Dr. Silberman is a Hematologist/Oncologist who earned her B.A., Sc.M. and Ph.D. from the Johns Hopkins University School of Arts and Sciences, School of Public Health and School of Medicine, respectively, and her M.D. from Cornell University Medical College, and then completed both a clinical fellowship in Hematology/Oncology as well as a research fellowship in tumor immunology at the Brigham & Women's Hospital and the Dana Farber Cancer Institute in Boston, MA. Dr. Silberman has played key roles in the development of many drugs including Gleevec™, for which she led the global clinical development at Novartis. Dr. Silberman advanced several original, proprietary compounds into Phases I through III during her work with leading biopharmaceutical companies, including Bristol-Myers Squibb, AstraZeneca, Imclone and Roche.
Matt Lourie, CPA is the CFO of CNS Pharmaceuticals, Inc. Mr. Lourie has extensive management, accounting and financial experience. Mr. Lourie served as an audit partner of the PCAOB registered firm MaloneBailey where he oversaw audits and financial reporting of SEC registrants. In addition, he served as the Corporate Controller of a public company with over 300 locations across the country. Mr. Lourie is a graduate of the University of Houston where he earned both his Bachelor of Business Administration - Accounting and his Masters of Science in Accounting.
Donald Picker, PhD, joined the CNS team in November, 2017 with over 35 years of drug development experience. At Johnson Matthey, Dr. Picker was responsible for the development of Carboplatin, one of the world’s leading cancer drugs, acquired by Bristol-Myers Squibb and with annual sales of over $500 million. He also oversaw the development of Satraplatin and Picoplatin, third-generation platinum drugs currently in late-stage clinical development. Dr. Picker has significant experience in dermatological pharmaceutical discovery and development as well, having led projects for topical therapies in psoriasis, atopic dermatitis and acne.
J. George Gumulka, PhD, has more than 30 years of industrial and academic experience primarily in the R&D functions. George is an accomplished technology leader with strong international experience and with an excellent track record of successful new product and application. He has led innovation, technology and supported business efforts at several major global chemical companies including., Royal Dutch Shell/Shell Chemical Company, Kraton Polymers U.S. LLC, and Biospectrum Inc. His experience crosses multiple global industrial sectors including biotechnology, polymer and elastomer applications in consumer products, electronics, general industrial, commercial and residential construction, oil transportation, water purification to name a few.
Waldemar Priebe, PhD, Chairman of the Scientific Advisory Board, is a world renowned medicinal chemist and entrepreneur. Dr. Priebe is a Professor of Medicinal Chemistry in the Section of Immunobiology and Drug Carriers in the Department of Bioimmunotherapy at MD Anderson. Dr. Priebe is the inventor of more than 50 patents and the author of more than 200 scientific publications. As the founder or founding scientist of 6 pharmaceutical companies, including three listed on NASDAQ, Dr. Priebe has been integral in advancing several drugs through the pipeline, five of which entered clinical development. Dr. Priebe led the research that formed basis for the development of agents with high brain uptake (BBB crossing) and is the discoverer of our lead drug candidate Berubicin.
Sigmund Hsu, MD is fellowship trained and certified by the American Board of Psychiatry and Neurology, with extensive experience in the evaluation and treatment of neurological disorders in cancer patients. He specializes in primary brain tumors as well as brain and spinal cord metastases, cancer neurology and the treatment of chemotherapy neurotoxicity. Dr. Hsu has presented research at several national conferences, and his work has been published in numerous journals and textbooks. His most recent research has focused on novel therapies for recurrent primary CNS lymphoma, recurrent glioblastoma multiforme and intralumbar injections for cancer therapy, and he has several patents granted and pending for his treatments.
Our first step is to raise the maximum funding allowed on Republic, which is $1,070,000. This is the campaign that you are currently viewing now.
Shortly after, we plan to begin a Regulation A+ equity crowdfunding campaign on Sprout Equity and raise up to $15,000,000.
After we close out the Reg A+ fundraising round, we plan on listing on the NASDAQ stock exchange in 2018.
The smallest investment amount that CNS Pharma is accepting.
CNS Pharma needs to reach their minimum funding goal before
the deadline. If they don’t, all investments will be refunded.
The Crowd SAFE is an agreement for future equity in the startup,
meaning that it can convert to equity in the future.
The Crowd SAFE is an agreement for future equity in the startup, meaning that it can convert to equity in the future.
$100,000 – $1,070,000
CNS Pharma needs to raise
before the deadline. The maximum amount CNS Pharma is willing
to raise is $1.07M.
My father was diagnosed with a glioblastoma and fighting! We need to find a cure and fast to beat this deadly disease. I believe this is the right steps in finding a cure!
I invested because my father died of brain cancer in 1967. My prayer ever since then has been for someone to find a cure.
I read their Form C, read up on backgrounds of founders, AND because CNS was rec by an advisory service to which I subscribe.
CNS Pharma was founded to bring breakthrough central nervous system drugs to market by utilizing new regulations recently approved by Congress. These new regulations allow individual investors, like yourself, the opportunity to be early stage investors as opposed to wall street bankers and venture capitalists.
Bringing a drug through a clinical trial and ultimately bringing it to market can take several years. Based on the compelling data relating to the mechanism of action of this novel drug, as well as initial clinical results in the Phase 1 study, this is planned as a multi-center Phase 2 study that will evaluate the efficacy of Berubicin in subjects who have Glioblastoma that has recurred or progressed following prior radiation therapy and temozolomide, which are the standards of care for newly diagnosed Glioblastoma. Approximately sixty (60) patients will be entered. Efficacy will be measured in terms of progression-free survival (PFS), which is a major endpoint in studies of Glioblastoma, using accepted methodology, corticosteroid usage, and neurologic status. All of these are considered important in terms of a disease that after failure of primary therapy is almost uniformly fatal. Median PFS is the primary efficacy endpoint defined as the number of months from the date of the first dose of berubicin to the date of first documentation of an event (progressive disease per standard radiographic criteria or death due to any cause). Note that in Glioblastoma, PFS and overall survival (OS) are strongly correlated, indicating that PFS may be an appropriate surrogate for OS. Compared with OS, PFS offers earlier assessment and higher statistical power at the time of analysis. We intend to keep our shareholders updated with press releases as we progress through the process.
No, we plan to license or develop additional Central Nervous System (CNS) anti-cancer drugs in the future to have a more diversified portfolio of drug candidates.
Subsequent to this fundraising campaign, we plan to raise funds under a Tier 2, Regulation A campaign. Our goal is to raise up to $15,000,000 in that campaign to fund our Phase II trials of Berubicin.
We plan to begin a Regulation A+ equity crowdfunding campaign on Sprout Equity and raise up to $15,000,000. After we close out the Reg A+ fundraising round, we plan on listing on the NASDAQ stock exchange in 2018, at which time investors could choose to sell their equity position or not.
Berubicin has no competitors that have proven to cure Glioblastoma. That said, the current standard of care involves surgical resection followed by radiation and treatment with Temozolamide. Almost all patients unfortunately still die of the disease following this program. There are also at least 23 ongoing Phase II or Phase III clinical trials of different combinations of drugs, any one of which might be effective against Glioblastoma. Of the many previous clinical trials, none have successfully provided a cure for Glioblastoma.
This capital will be used to fund early work needed to prepare for Berubicin’s Phase II Clinical Trial. This may include beginning production on the basic materials used to create Berubicin, paying the salaries of employees and general & administrative expenses. We have a tremendous advantage in that our collaboration agreement with Reata Pharmaceuticals enables us to use all the data from their 2009 Phase I study of Berubicin. As we mentioned earlier, we also intend to complete an IPO with an offering of up to $15,000,000 later this year. Those funds will be used in part to conduct this development work.
We believe Berubicin has the potential to become the standard of care treatment for recurrent and Temozolomide (TMZ) resistant Glioblastoma. CNS will plan future clinical trials to establish Berubicin as an upfront treatment for Glioblastoma. Based on currently available sales figures for TMZ, if approved, the initial market size for Berubicin could be up to $1 billion.
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