- CNS Pharmaceuticals is a pre-clinical-stage developer of novel brain cancer-fighting drugs, including its lead candidate Berubicin
- The company is working to build on promising results from a 2006 Phase I trial, which provided 44 percent of its limited patient pool with clinically significant improvement in disease stability and one patient with a durable complete response (no evidence of any tumor remaining) for over 14 years
- CNS Pharmaceuticals expects to launch a pivotal Phase II trial of Berubicin at the beginning of next year and has been assembling a team of partner companies help with the trial
- CNS recently announced that the partner contracted to manufacture the Active Pharmaceutical Ingredient (API) for Berubicin has received a Certificate of Analysis necessary for the drug substance to be used in the clinical trial
- The company is also preparing in collaboration with its sub licensed partner, WPD Pharmaceuticals, for the first Phase I pediatric trial of Berubicin
- CNS is continuing the pre-clinical development of the company’s second promising cancer-fighting drug candidate, WP1244
Houston, Texas-based biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) continues to achieve milestones in its drive to defeat glioblastoma multiforme (“GBM”), a relentless type of brain tumor known for very rapid progression and very short survival periods in nearly all patients once they’ve been diagnosed.
“If you get glioblastoma, the sad fact is you’re going to die from that disease,” CNS Pharmaceuticals CEO John Climaco told attendees at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit in September during a discussion about the aggressive brain tumors and the company’s investment potential as it advances tumor-fighting drug candidates (https://ibn.fm/t13u4). “We believe that [our drug candidate] Berubicin could potentially be a game-changer,” Climaco continued.
CNS Pharmaceuticals is in the process of developing the testing infrastructure for its its lead novel drug candidate, an anthracycline called Berubicin. The company announced at the beginning of this month that a partner company contracted to manufacture Berubicin active pharma ingredient (API) received a Certificate of Analysis, clearing it for use in the production of the Berubicin drug product in preparation for use in the clinical trial (https://ibn.fm/N2AMO).
Berubicin has shown the potential to stand out from other tumor-killing anthracyclines because it has the ability to cross the human body’s Blood-Brain Barrier (“BBB”) and sequester itself preferentially in tumor tissue, the company’s website states (https://ibn.fm/F8SNr).
The blood-brain barrier is a wall of specialized endothelial cells that separate the blood circulatory system from the brain and kick out recognized toxins such as anthracyclines before they can affect the body’s central nervous system. “That’s why anthracyclines kill glioblastoma cells in test tubes but don’t affect glioblastoma tumors when given to people,” the website states.
In a limited Phase I trial conducted in 2006, Berubicin showed evidence of prompting improved survival in a patient population that has a median survival rate of only 14.6 months from the date of the disease’s diagnosis, and one of the trial’s patients remains cancer-free as of the last assessment on Feb. 20 of this year, approximately 14 years later, Climaco said.
Tumors are generally first removed surgically to the extent possible, but then tend to recur.
The pharmaceutical temozolomide has been shown useful as a first-line response in temporarily extending the lifespan of fewer than 40 percent of GBM patients with a specific genetic variation, but even nearly all of those patients develop resistance to temozolomide within about a year’s time and CNS hopes to present Berubicin as a second-line therapy.
The contracts with drug manufacturers Pii and BSP will provide drug product for CNS’s Phase II clinical trial as well as two trials in Poland to be conducted by sub licensee partner, WPD Pharmaceuticals, including a Phase 2 adult trial and a first-ever Phase 1 pediatric trial, both of which are expected to launch during Q1 of 2021. The company recently announced an agreement with medical imaging company Image Analysis Group (“IAG”) to evaluate the upcoming clinical trial imaging results in real time using AI-driven technology (https://ibn.fm/TlKhu).
CNS Pharmaceuticals is also conducting pre-clinical development on a drug candidate known as WP1244 that has been shown in preclinical studies to have a DNA-binding agent 500 times more potent than chemotherapy drug daunorubicin in stopping tumor cell expansion.
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