CNS Pharmaceuticals (NASDAQ: CNSP) Reaches Milestone with Enrollment of 200 Patients in Ongoing Potentially Pivotal Study of Berubicin with the Treatm
Enrollment process for the study will be successfully finished by the conclusion of 2023.
Results from the initial analysis, which will provide a summary of the key findings, are expected to be announced before the end of 2023.
Houston, Texas - September 7, 2023 - CNS Pharmaceuticals, Inc. (NASDAQ:CNSP), a company that focuses on developing new therapies for primary and metastatic brain and central nervous system cancers, shared today that they have enrolled 200 out of 243 anticipated patients in their current significant study to assess Berubicin as a potential treatment for recurring GBM, a severe and untreatable type of brain cancer.
This important global research on Berubicin is a flexible and widespread study that involves multiple centers and is open to adults with recurrent GBM (Grade IV according to WHO) who have not responded to traditional first-line treatment. It will be compared to Lomustine, which is the current standard treatment. The main goal of the study is to measure Overall Survival (OS), which is a very strict measure that the FDA considers when deciding whether to approve cancer medications. The study will be conducted at 46 clinical trial locations out of the total of 60 sites chosen in countries such as the United States, Italy, France, Spain, and Switzerland.
As we have mentioned before, the individuals who volunteer as patients and their medical professionals who treat them play a crucial role in our development program for Berubicin. We are fully aware of the fact that these courageous patients are currently fighting the most difficult battle of their lives, and we will forever be grateful for the trust and confidence they have placed in Berubicin and our company. The fact that 200 of these individuals have joined our trial is significant because it helps us gather a large and diverse group of participants that we have been aiming for from the very beginning. We understand that we cannot move forward with this promising drug candidate without these extraordinary patients. Additionally, we believe that the speed and consistency at which participants are enrolling in the trial is not only impressive in itself but also indicates the immense interest and excitement among our investigators and patients. Fighting this devastating disease remains our main driving force, and we are thrilled to reach this important milestone. This milestone brings us one step closer to completing the study and potentially providing a safe and well-tolerated treatment option for GBM. According to John Climaco, the CEO of CNS Pharmaceuticals, "We are pleased to reach this landmark milestone as it signifies progress towards our goal of offering a safe and effective treatment for GBM."
As mentioned before, CNS Pharmaceuticals has met the necessary requirements outlined in the study plan to carry out a pre-determined analysis to assess the effectiveness of Berubicin as a second-line treatment for glioblastoma patients. This analysis will be conducted by an independent Data Safety Monitoring Board (DSMB), who will determine whether to proceed with the study as planned or make modifications based on the potential value of Berubicin. CNS Pharmaceuticals had previously stated that this analysis would take place once at least 50% of the patients in the selected group (30-50% of the total patients involved in the trial) had reached the main efficacy endpoint, as outlined in the study plan. The DSMB will evaluate the number of deaths in each group to ensure that the survival rate for patients receiving Berubicin is statistically comparable to those receiving Lomustine. Furthermore, additional assessments will include comparisons of secondary endpoints such as progression-free survival (PFS), response rates, and safety evaluations. The company is confident that the results from the interim analysis will be publicly announced before the end of the year. Patient enrollment will continue during this interim analysis.
To gather additional details regarding this experiment, please visit clinicaltrials.gov and make a note of the reference code NCT04762069.
The FDA has given CNS Pharmaceuticals a special designation called Fast Track Designation for their drug Berubicin. This means that CNS Pharmaceuticals can have more regular meetings with the FDA to get advice on speeding up the development and review of Berubicin. On top of that, the company has also been given Orphan Drug Designation by the FDA. This could give them exclusive rights to market Berubicin for seven years after it gets approved.
Berubicin belongs to a group of powerful chemotherapy drugs called anthracyclines. These drugs are effective against many different types of cancer and work by damaging the DNA in cancer cells. Specifically, they target an enzyme called topoisomerase II, which is important for cell growth. Reata Pharmaceuticals, Inc. conducted a Phase 1 clinical trial on brain cancer patients and saw positive results, including one patient who had a lasting complete response to Berubicin treatment. The drug was developed by Dr. Waldemar Priebe, a Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.
CNS Pharmaceuticals, Inc. is a company specialized in the field of neuroscience, particularly focusing on the study and development of pharmaceutical products. As a company, CNS Pharmaceuticals, Inc. is passionate about making significant breakthroughs in the treatment of various central nervous system disorders. They are committed to conducting extensive research and clinical trials to bring innovative pharmaceutical solutions to those in need. With their expertise and dedication, CNS Pharmaceuticals, Inc. is striving to improve the lives of individuals suffering from neurological illnesses.
CNS Pharmaceuticals is a company that is in the process of creating drugs to fight against different types of cancer that affect the brain and central nervous system. The main drug they are focused on is called Berubicin. It is a unique type of drug that is able to enter the brain through the blood-brain barrier. Berubicin is currently being developed to treat various types of aggressive brain and central nervous system cancers, including glioblastoma multiforme (GBM), which is a particularly difficult form of brain cancer that currently has no cure.
To find out more, kindly visit www.CNSPharma.com and engage with the Company on Twitter, Facebook, and LinkedIn.
Some of the statements in this press release are predictions about the future and involve risks and uncertainties. These predictions include the Company's plans to complete the study and analyze the results before the end of the year, their ability to open more clinical trial sites on time, and whether the FDA will accept their main objective as a basis for approval. These statements relate to future events, expectations, plans, and possibilities. Although CNS believes that these predictions are reasonable as of now, the actual results may be different. CNS has tried to identify these predictions by using words like "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately," or other words that show uncertainty about the future. These statements are only guesses and involve known and unknown risks, uncertainties, and other factors. You can find more information about these risks and uncertainties in CNS's most recent Form 10-K filed with the SEC. Any predictions in this press release are only accurate as of the date they were made. CNS does not have to update any predictions in this press release to show events that happen after the date or events that were not expected.
Contact for Investor RelationsJTC Team, LLCJenene [email protected]
Original: CNS Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel treatments for primary and metastatic cancers of the central nervous system. Rewritten: CNS Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in creating new therapies for primary and spreading cancers that affect the brain and spinal cord.
