- A novel anthracycline believed to be effective in combatting deadly glioblastoma brain cancers by crossing the blood-brain barrier and zeroing in on the tumor will begin Phase 2 trials during Q1 of next year
- The drug, Berubicin, is being developed by CNS Pharmaceuticals after initial testing nearly 15 years ago resulted in improvements among some subjects, including one who has survived cancer-free since that time
- The company, in collaboration with Polish sub-licensee partner WPD Pharmaceuticals, plans a multinational staged series of trials that will attempt to keep time and costs to outcome at a minimum
- As part of the effort, CNS and WPD plan to conduct the first-ever pediatric Phase 1 trial of Berubicin in children with no other recourse
Brain cancers that are relentless and effectively incurable have caught the attention of drug maker CNS Pharmaceuticals (NASDAQ: CNSP), which is working to complete testing of its lead candidate in hopes of finding a cure against those central nervous system disorders.
The drug, Berubicin, is an anthracycline with the novel distinction of being able to cross the blood-brain barrier to combat tumors — something all other anthracyclines are unable to do. Nearly 15 years ago, Berubicin was the subject of a Phase 1 safety trial conducted by Reata Pharmaceuticals. The limited study resulted not only in a finding of safe usage, but in two patients reductions of greater than 25 percent in the size of their tumors (one achieved an 80% reduction in the tumor) while another patient became cancer-free (known as a durable complete response) and has remained cancer-free to the present, as noted in a recent company webinar (https://ibn.fm/WnXTx).
CNS obtained rights to Berubicin and its related clinical data. The company was awarded Orphan Drug Designation (“ODD“) for Berubicin in treating malignant glioma cancers (an indication much broader than the current investigational target of glioblastoma multiforme) and announced Nov. 17 that it had filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”), which had been accepted for review (https://ibn.fm/T6idd). Thirty days later the Company announced that its IND for Berubicin for the treatment of Glioblastoma Multiforme (“GBM”) was approved and in effect as filed with the US Food and Drug Administration (“FDA”).
CNS continues to methodically develop its plan of attack with Berubicin, planning to launch a Phase 2 trial during the first quarter of 2021, which will involve randomized and controlled comparative administration of Berubicin and the chemotherapy drug lomustine to 243 patients. Lomustine is widely considered to be the second-line standard-of-care therapy despite not being formally approved as such.
The trial will take place at about 60 study centers in North America, Europe and the Asia-Pacific region, searching for proof that Berubicin patients may benefit from reduced tumor size or even just from arrested development of the tumor’s growth. And, ultimately, the overall survival of the patients, of course.
Glioblastoma patients have been found to have a median survival rate of only 14.6 months from the date of the malignancy’s diagnosis. With surgical intervention, the cancer tends to recur and adapt to pharmaceutical interventions. The Phase 1 patient’s survival without cancer recurrence during the past 14 years is seen as significant cause for optimism.
Concurrent with the multinational Berubicin trial, CNS Pharmaceuticals is partnering with Europe’s WPD Pharmaceuticals to launch a first-ever Phase 1 Berubicin pediatric safety trial in Poland during Q1 of 2021 for children who have the GBM tumor and have run out of other medical options. WPD will also conduct a Phase 2 trial on the adult use of Berubicin. Under the licensing agreement, WPD will pay a minimum of $2 million on the development of Berubicin and pay CNS a royalty fee on sales.
WPD received a $6 million development grant in January from the European Union to complete the two trials, which significantly increases CNS’s ability to complete the Berubicin trials without the degree of spending and equity dilution that might have occurred otherwise. In an effort to further control those outlays of capital, CNS CEO John Climaco stated during the webinar that the company will complete the trials in stages over the next two to two-and-a-half years, funding each successive stage as results from achieved milestones show the efficacy of continuing to proceed forward.
The trials are expected to cost $30 million to $35 million by the time they are completed. In the meantime, the company also hopes positive results from the trials will convince the FDA to grant Berubicin an expedited pathway to approval, which would reduce the time and cost of the trials to an even greater degree. The company recently announced the sale of $10 million of stock in a public offering and has also secured up to $15 million in potential equity financing via an equity line facility with Lincoln Park Capital.
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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